chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 23 year old female with asthma and no known drug reactions/allergies, who on 21-JAN-2009 was vaccinated with the first dose of GARDASIL, 0.5ml intramuscularly. Concomitant therapy included albuterol. The registered nurse reported that the patient was pregnant. On an unspecified date, the patient had a positive beta-human chorionic gonadotropin pregnancy test. Date of last menstrual period was on 24-OCT-2008. The estimated delivery date is 31-JUL-2009. The patient sought medical attention and was seen at the practice. Follow-up information was received from a questionnaire completed by a gynecologist indicating that the patient was a female, with cervical dysplasia and with a history of 1 pregnancy, 1 live birth and no pre-term deliveries, spontaneous abortions, elective terminations nor fetal deaths, who on 21-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # 661703/0651X). Concomitant therapy included albuterol. Medications taken during the pregnancy included folic acid and prenatal vitamins. Routine prenatal testing included a routine ultrasound performed on 06-MAR-2009, which detected bicornuate uterus and fluid filled cyst. Follow-up information was received on 19-MAR-2009 from the licensed practical nurse, clarifying that the bicornuate uterus and fluid filled cyst was in the mother and not in the fetus. She also mentioned that it was a left ovarian ovarian fluid filled cyst. Additional information has been requested.
20 Patients received Spikevax past the 30 day expiration date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case belongs to 5 of 20 patients described by the reporter.  No concomitant and treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Pt reports Hard, Red, Raised, itchy rash around injections site starting 7 days post injection.
08/28/2021- Everything started swelling, neck swelling, throat swelling, hives, nerve pain, fever, nerve pain rapid heart beat, low oxygen level, headaches, eye pain and tendonitis
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 1, single (Lot number: EW0158), in left arm and on 01May2022 as dose 2, single (Lot number: EW0175) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: other medical history: Crohn's disease; "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin; "rheumatoid arthritis" (unspecified if ongoing), notes: other medical history: rheumatoid arthritis; "chronic pain" (unspecified if ongoing), notes: other medical history: chronic pain. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0158 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0158, fill lot EP8693, and the bulk formulated drug product lot EW8072. The final scope included the reported finished goods lot EW0175, fill lot EP8726, and the bulk formulated drug product EP8607. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. ID of Previously Completed Inv: Link (Previously Investigated CR): ID of Previously Completed Inv:   Clinical course: It was reported that, the patient received Paxlovid for the treatment of Covid-19 from 02Oct2022 to 07Oct2022. The patient received other medications in 2 weeks.
Flu shot site was sore for about 2 days then I started feeling severe sharp pain shooting from my left shoulder to elbow. Unable to life much weight with the left arm. By October 14 pain traveled from left shoulder to left wrist was suddenly moved or when used. Unable to raise left arm or pick up her young child. Saw physician on 10-15-2015. Prescribed anti-inflammatory medications and rest. Out of work for 3 days. Symptoms persisted, and physical therapy was prescribed and received. As of January 08, pain had improved after therapy but once therapy was discontinued, the symptoms recurred, and now the pain prevents sleep. Physical therapy is to resume.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.   60 doses was received to several patient from Lot AS7148B. Concomitant medications were not reported.  No treatment information was provided
Patient made an appointment to receive the Hepatitis B vaccine. Our staff inadvertently administered the Hepatitis A vaccine. This error was disclosed to the patient and patient returned to have the correct vaccine (Hepatitis B) administered.
ED  - Discharged  8/22/2021 (1 hours); Last attending ? Treatment team COVID-19 Clinical impression Covid-19 Screening Chief complaint  Covid-19 Screening, congestion.
Extreme fatigue, lack of energy for 11 days  diarrhea the next day off and on nausea, head ache, sweats, chills for past 11 days One week after vaccine had a telehealth appointment with primary care, COVID test (Negative), and blood work.  Blood work was normal and tested negative for antibody to COVID.   Have missed work for 7 days.  Still no energy (day 11).  Exhausted after minimal activity.  Sweat through my nightshirt overnight (day 10), extreme chills prior.
Vertigo; condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and CONDITION AGGRAVATED (condition aggravated) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Benign positional vertigo in 2020. Concurrent medical conditions included Hypertension (mild blood pressure). Concomitant products included METOPROLOL SUCCINATE for Hypertension.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VERTIGO (Vertigo) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, VERTIGO (Vertigo) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Blood pressure measurement: 167 167.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided.  Company comment: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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: reporter's email was updated to the case; Sender'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.
Right leg swelling that involved 50% of the leg surrounding the injection site. There was associated erythema. There was no induration. Onset was within the first 24 hours. Thought to be due to Kinrix.
tingling all over, difficulty breathing, dizziness; referred to MD; went to MD office & began to feel better & did not want to see MD;
I have been experiencing pulsatile tinnitus in my ears since having the injection for 2+ weeks now.
This spontaneous report was received from a certified medical assistant concerning seven patients (ages and genders not specified). On an unspecified date, doses of VARIVAX (Merck) 0.5 mL that underwent a temperature excursion were administered to seven unspecified patients. No adverse effect was reported. Additional information has been requested.
I got face numbness; Numbness on my lips, tongue, all the way to my left eye mostly in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I got face numbness) and HYPOAESTHESIA ORAL (Numbness on my lips, tongue, all the way to my left eye mostly in my mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (I got face numbness) and HYPOAESTHESIA ORAL (Numbness on my lips, tongue, all the way to my left eye mostly in my mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (I got face numbness) and HYPOAESTHESIA ORAL (Numbness on my lips, tongue, all the way to my left eye mostly in my mouth) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.
fever 101 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101 F) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever 101 F). At the time of the report, PYREXIA (fever 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 F.         No concomitant medication was reported. No treatment medication was reported.
5/27) pt had varicella vaccine.  5/28) pt noted inflammation, redness + pain at injection site.  5/29) pt came back to clinic - left upper arm 3x4" area of redness, warmth + edema.
Chills, fever, shortness of breath, ascending paralysis, chest pain, difficulty breathing and speaking, difficulty getting the words out, chest pain with breathing at certain points, chest pain and discomfort with exertion and taking a shower, stiff neck, weakness in left arm, weakness in left side of body, weakness in both arms and both legs, generalized weakness, chest pain when inside a moving car that turns, breaks, or hits indentations on the surface of the street, crushing chest pain, cramps in arms, coldness in arms and legs, coldness in legs alone, dizziness, nausea, stomach sensitivity, chest surface sensitivity to pressure, high blood pressure on multiple occasions (over 150/100 on multiple occasions), significant difference in blood pressure upon standing and not standing (possible postural orthostatic tachycardia syndrome), high D- dimer, MPV of 9.7, 3+ ketones in urine, 1+ bilirubin in urine, trace proteins present in urine, amber urine color,  potassium of 3.2, platelets of 9.7, in addition to a relative lymphocyte count of 7.4, an absolute lymphocyte count of 0.5, a relative neutrophil count of 87, chest discomfort upon leaning back, chest discomfort upon moving arms, tingling in hands, dry palms, sweaty palms, numb palms, episodes where I breathed abnormally and had to purse my lips, episodes where I had to spread my legs and arms in a laid position to avoid additional labored breathing,
1. When first administered, the pain shot around my arm. After moving it a lot, it subsided in a few hours. It is now just dull. 2. I began to feel dizzy and woozy around 4:00 p.m. the day of the vaccination. 3. Now, I have tinnitus, waves of shocking through my head, and a fever of 99.7, in addition to being 1000mg of acetaminophen.  4. I have been taking normal amounts of Airborn, probiotics, and calcium.
I contracted Covid-19 I had a cough and chest congestion, sinus congestion runny, nose mucus head ache fatigue and laryngitis.
Redness and warmth in the area and sureounding area of where the vaccine was given.
For two days pt. became overly lethargic and was difficult to arouse. His heart rate and respiratory rate were both very high before his fever began, and of course worsened as his fever increased. When he woke up on the third day he had improved significantly. He has had all of his vaccinations up to this point and has never reacted this severely.
I had a fever that went up to 102.4F by midnight, severe chills, and muscle pain.  I took some medicines.
11-18-14 Developed urticaria (lg had rash with welts over entire body) day after receiving immunization. 11-20-14 Mom called and stated rash has resolved.
Patient received 1st COVID vaccine and was sitting in the waiting area afterward.  He told his fiance that he felt "hot" and was going to the bathroom.  While in there, he passed out and hit the bathroom wall.  He was observed by EMTs and refused transport to the hospital.  He left walking out with his fiance.
Redness around injection sites of both arms. Slide warm to the site. Flu like symptoms. No streaking of redness for local sites.
This medically confirmed spontaneous report (initial receipt: 18-Sep-2012) concerns a female patient, who had an allergic reaction to pneumonia vaccine which she described as 'quite severe'. On an unknown date the patient received a flu vaccine (manufacturer, brand name and lot number were not provided) and experienced allergic reaction. The event outcome was not reported.
My arm starting hurting the next day and it has not stopped since. I can feel the exact spott the shot ws give when I move my arm. It has now been 4 months and I never had a reaction to any of the other injections. I went Urgent Care on 01/09/2023 My right arm was X-Rayed it did not show anything. The PA gave me some arm strengthening exercises to do, however that has not helped. This is not normal I feel like I have lost strength and mobility in it.
04/01/2021 the day after the vaccination, I like a flush, lightheadedness, like I was going to pass out. I felt like a fever breaking. It lasted like 5 minutes and then I was fine. 09/27/2021 went to urgent care. I was diagnosed with Shingles. They prescribed antiviral medication, famciclovir 500 mg, 3 x day. I do not think this is an AE from my vaccine. I was also having a scratchy throat and runny nose and I thought it was the  start of a sinus infection. They gave me a COVID-19 rapid test-the results were negative. They told me if the symptoms continued to come back and get retested. 10/01/2021, the symptoms continued. I was given another rapid COVID-19 test- the results were negative. 10/05/2021, I am still recovering from the shingles and COVID-19. I am quarantining.
Rash covering about half the body that's red, raised, and hives-like in certain areas. Areas included patient's arms, axillary area, breasts, sides, stomach, and back. The rash began the morning after administration of the vaccine and is extremely itchy and irritating. The patient sough emergency treatment for it. She also said she had a pounding headache that began the night of vaccine administration and had persisted for 3 days. Patient states she did not have any type of rash following the first or second doses of the vaccine.
respiratory issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient in their 60's received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory issues".  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Sharp, stabbing pain moving into my right armpit and right side of neck, numbness to the entire right arm, loss of strength in entire right arm, painful to touch right arm where pain is located
Fever 39 C; Moderate Chills; Moderate muscle pain; mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 17Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. Patient had no allergies to medications, food, or other products. Patient had not tested for COVID-19, since the vaccination. The patient experienced fever with temperature 39 degrees Celsius, moderate chills, moderate muscle pain and mild nausea on 18Mar2021. Therapeutic measures were taken as a result of adverse events and included treatment with paracetamol and Ibuprofen. The clinical outcome of the fever with temperature 39 degrees Celsius, moderate chills, moderate muscle pain and mild nausea were not recovered.   No follow-up attempts are needed. No further information is expected.
Information has been received from a Physician Assistant (P.A) concerning a 15 year old female patient who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # not reported). It was reported that the patient fainted right after receiving the first dose of GARDASIL on 13-JUN-2009. It was reported that the patient was was brought to the emergency room and stayed there for a few hours. The patient was not admitted to the hospital. The patient sought medical attention with the Physician Assistant. There was a blood work performed (results not provided). It was reported that the adverse event had improved at the time of the report. All telephone attempts to contact the reporter have been unsuccessful. Follow up information was received from a Physician Assistant (P.A) on 23-JUN-2009 via telephone reported that the patient with no pertinent medical history or known drug allergies was vaccinated with the first dose of GARDASIL (Lot # 661846/1312X) on 13-JUN-2009. On 13-JUN-2009 the patient was very anxious and hadn't eaten since the night before. There were no concomitant medications and no other vaccinations given that day. After having fainted for only a few seconds, the patient was monitored in the office for the next 45 minutes. The vital signs and blood sugars were normal, but the patient was nauseous, lethargic and pale. She was transported to the emergency room. It was unknown what tests - other than blood work - were performed. The event was considered disabling for about five hours. The patient had fully recovered. The reporter considered fainted, nauseous, lethargic and pale to be significant disability/disabling. No further information is available.