chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash got worse again a few days after second dose/ red and hot rash; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at left arm on 15Feb2021 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications in two weeks. The patient did not received any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at left arm on 25Jan2021 at 09:00 (24-year-old at time of vaccination) at single dose for COVID-19 immunization and experienced red and hot rash on the same arm (located in the crease of the elbow and about 5 inches in diameter) from 01Feb2021 at 08:00; received cortisone for the rash (it got better). Rash got worse again a few days after second dose in Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not test COVID post vaccination. Therapeutic measures were taken as a result of the event and included cortisone. The outcome of the event was recovering.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: patient had severe pain and swelling in arm and sharp pains in neck. Referred her to PCP.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 69-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that their facility had not been able to download  they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine. It was reported that, the facility was unable to download & they would need to treat this issue as a temperature excursion. The data was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  No treatment medications were reported.  The reporter stated that no adverse reactions were reported by any patients.
Localized reaction: pain, swelling, and erythema in the area surrounding the injection site (>4 inches in diameter surrounding injection site).  Developed during evening of the day injection was given, continued through next day, is resolving on second day following injection.  Treatment recommended: ice pack to affected area, acetaminophen, diphenhydramine.
Pt came to emergency dept complaining of rash to upper lateral left arm: a 5 x 5 cm area with honey color crust, mild surrounding erythema and several small vesicles. She reported receiving small pox vaccination at the site 10 days ago (on 8/19). Clinical impression: Impetigo Rx: Keflex 500 mg q 6 hours x 10 days. Temp 102.3. Complained of nausea and vomiting.
101 Fever along with the chills. Sweating began around 3:00 AM. Fever began to subside around 9:00 am. Fever was gone around 12:00 PM.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided. Patient did not experience any other adverse reactions.   This case was linked to (Patient Link).
Pt had a syncopal episode, fell and hit her head on the floor.  Became diaphoretic, Pulse 80/palp, pulse 42.  Immediately regained consciousness and was A&Ox3
Myalgia & Arthralgia Narrative:  Missed work following first dose due to above symptoms
fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 13Jan2021 09:45 at single dose in left arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no covid prior vaccination and no covid tested post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), via an unspecified route of administration on 23Dec2020 14:45 at single dose in left arm for COVID-19 immunization. The patient experienced pain at injection site, chills, body aches, headache, neck pain, joint pain, nausea, fatigue on 14Jan2021 02:00. The outcome of the events was recovered in Jan2021. The patient did not receive treatment for the events.  No follow-up attempts are possible. No further information is expected.
Patient arrived for 1 st covid vaccine, Patient  given Moderna biv infant dose from pink yellow vial intead of dose from moderna biv blue top.
A day after receiving my first vaccine, the onset of ringing in my ears began and my ear felt full and I had dizziness.  I went to my primary Doctor and she ruled out ear infection and referred me to an ENT doctor and an audiologist. They gave me an audiogram and then the ENT doctor could not give a definite diagnosis except that I now have hearing loss  in both my ears and tinnitus could be a chronic issue. I continue to suffer  hearing loss and tinnitus in my ears since I received my vaccine and it continues to this day.
Per Dr, patient has Guillain-Barre Syndrome.  On 10-3-21 patient experienced problems walking, poor gait affecting his lower back to knees.  Patient started IgIV therapy on 10-20-21.  The patient completed 5 treaments from 10-20-21 to 10-27-21.  Patient states he is improving.
Information has been received from a nurse concerning a 19 year old female with asthma, hirsutism and polycystic ovarian syndrome and no known drug allergies, who 2 years ago was vaccinated with a first dose of GARDASIL. On 30-DEC-2008 the patient received a 0.5 mL second dose of GARDASIL (lot # 659184/0843X), intramuscularly. Concomitant therapy included Ocella. Ten minutes after the administration of the second dose the patient experienced syncope. The patient was "in and out of consciousness" for 4 to 5 minutes. She also experienced nausea and tingling sensation in her arm. There were no laboratory diagnostics studies performed. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
The patient received an unauthorized vaccine/ patient was not age 12 at the time the vaccine was administered
After getting 2nd dose of Moderna Vaccine on 3/18/21 @ 1335, patient developed a blister next to the injection site on the left arm on the area covered by the band aid which was discovered by the patient at 1215 pm on 3/19/21.  The blister has a clear fluid and is not causing much discomfort.
pt recv vax JUN97 & about 1wk later pt exp about 101 lesions the first day & a few more the next day;
At 2am I began experiencing painful cramping in my lower abdomen. It felt like a combination of severe gas build up and birthing pains. I fly extremely nauseous but never vomited.
I was diagnosed as having gynecomastia .  I first noticed pain in my right breast right below the nipple.  The pain continues until this day.  My breast has not changed in size significantly.
Fluarix QIV instead of Pediarix; Fluarix vaccines was given to a 2 months  baby; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 2-month-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the Fluarix vaccine was given by error to a 2 months baby instead of Pediarix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
as soon as need came out of patient's arm felt shaky in the left arm (same side as injection), followed immediately by a clogged ear sensation (bilaterally) then felt dizziness and nausea then felt clammy. Patients heart rate dropped to 47 with SPO2 94 that fluctuated up and then patient became clammy with rapid recover 1 minute. Total time feeling sensations between 2-5minutes
Enlarged and painful lymph node in left armpit; Enlarged and painful lymph node in left armpit; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EC3246), via an unspecified route of administration at left arm on 12Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (Lot number: EK5730) at left arm for covid-19 immunization. The patient experienced enlarged and painful lymph node in left armpit on 13Jan2021 with outcome of not recovered. No treatment received for the adverse events.  No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
STIFF NECK; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the patient experienced stiff neck, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and headache. This report was non-serious This report was associated with product quality complaint: 90000214169
Starting the evening of 10/20/2021, I laid down to take a nap. When I woke up, I had a temp of 102.8 and couldn't breathe. I took some Tylenol and 3 breathing treatments. The breathing treatments helped, but my temperature stayed elevated. I called the Doctor on call at my PCPs office and asked if I could take aspirin due to my temperature not lowering with tylenol AND being on Xarelto. I got the okay, and I took an aspirin. Within 30 min, my temperature had dropped to around 100. I continued to monitor my temp to ensure it continued to come down.  Also, doctor put me on Ceftin and steroids. I took one more breathing treatment before bed and continued to use cold compresses to help my temperature come down. My 02 stats were 88-89 when this began, and I was tachycardia (due to bronchospasms and fever) and after the breathing treatments) my 02 stats came back up to 92. I remained tachycardia until my fever broke. I did a COVID at home test 2 days later that was negative.
Pt. had severe pain after administration that became worse over the course of several days. Pt has had an MRI and prednisone course with no resolve. Pt. is going to see orthopedist.
Information has been received from an LPN concerning a 12 month old male with eggs allergy who in 1996 was vaccinated with the 1st dose of MMRII, 4 years ago. Within 24 hours, the pt experienced trouble breathing and coughing. On 9/10/01, the LPN reported the pt "just received his 2nd vaccination with MMRII, with no adverse event". No further information is available.
Pt called on 12-10-18 and said that left arm had been hurting since she got the shot and was getting progressively worse and going down (L) arm and up her neck. She said skin did not look swollen or abnormal. Nurse told her to see Dr. ASAP.
BlurredVision, Tachycardia, "feel very hot" Narrative:
Bruising and swelling at injection site, headaches, slight nausea on one day, and sporadic ringing in the ears.
40 Y.O female was received 1st dose Moderna vaccine lot# 025L21B on 3/1/2022 at 1544.. Patient started having hives, redness on her neck, forehead and arms. Patient complained of feeling drowsy. Denied shortness of breath. At 1600, Benadryl 50mg/1ml IM to Left deltoid muscle was given. Patient stated her baseline BP is 110/60. at 1600,  patient's BP was 103/58 HR 77, O2 99%. At 1621, the redness and hives started disappearing on patient's neck and arms. Her BP was 109/64, HR 73, O2 100%. Educated regarding allergic reactions to seek emergency services if reaction persist. The patient was recommended to have someone to pick her up instead of driving. Patient stated that she is fine to drive. The patient was escorted to her car.
My husband died of ?heart Attack? on April 17, 2021  Had an enlarge hearth and rupture in the Aortic Artery
Massive headache, fever: 101 degrees, fatigue: napped the entire day: got up at 7:30, slept from 8:30-11:30, slept again from 1-2:30, slept again from 3-5pm, no appetite, metallic taste in mouth flu-like symptoms: achy muscles, chills.
irritability, fatigue, chills, body aches, headache, nausea, dry-heaving, and vomiting.
itchiness; a little pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and PAIN (a little pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness) and PAIN (a little pain). At the time of the report, PRURITUS (itchiness) and PAIN (a little pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
The patient had a seizure 4 hours after receiving his first dose of the Pfizer Covid Vaccine. He has no history of seizures. As a result of his seizure, he was driving a moped which turned over and he has sustained severe brain injury/ Diffuse Brain Injury with left and right side nerve cell damage. He has been at the Medical Center, ICU Unit. Case Mgr., and Dr., Neurologist was called and was available for my questions.
Patient became lightheaded and weak after vaccine.   Has had previous episodes over the last few months, regardless of vaccainations.  Patient taken from store by ambulance to hospital.
Information has been received from a hospital pharmacist concerning a patient who on unknown date, were vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported). It was reported that on unknown date, the patient had "sensitivity reactions" to PNEUMOVAX 23 at the injection site, one of them "was bad and got really hard". It was also reported that on unknown date, the patient was "on the floor" at the hospital (date, duration and location unspecified). The patient's outcome was unknown at the time of report. This is one of several reports from the same source. Additional information has been requested.
2nd dose was scheduled for 25Jan2021, but she has not received yet; COVID-19 virus test positive; A spontaneous report was received from a consumer concerning a 62-year-old, female patient who was administered Moderna's COVID-19 vaccine and tested positive for COVID and her 2nd dose was scheduled but she has not received yet.  The patient's medical history included high blood pressure and high cholesterol. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number:025L20A) unknown route of administration on 30 Dec 2020.   Patient received the first dose on 30 Dec 2020. Patient tested positive for COVID on 20 Jan 2021. Her second dose was scheduled for 25 Jan 2021, but she has no received yet. Patient wanted to know if she should receive the 2nd Moderna vaccine. No treatment information was provided.  Consent to follow up was given.  The second dose of mRNA-1273 was discontinued in response to the event.  The event, her 2nd dose was scheduled but she has not received yet were considered resolved. The outcome for the event tested positive for COVID considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Initial report received on 03 February 2011 from a company representative who had received the report from a nurse who had received the original report from a health care professional. A 40 year-old male patient had received a dose of FLUZONE SV 2010-2011 (lot number U3651AA) during a flu clinic that took place at his place of employment on 01 November 2010. Since the vaccination, the patient has experienced difficulty with opening his eye, and has since been hospitalized. The hospital linked the patient's eye problem to the flu vaccination. The patient has not recovered. No further information was provided. Documents held by sender: None.
Pt developed shingles starting about 9/13/19 in C2 distribution left side of neck.  This was 8 days after her first shingrix vaccine.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 09-weeks-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 09-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
as if caller was hit by a truck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Lot number: Not Provided) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "as if caller was hit by a truck". No follow-up attempts are possible. No further information is expected.
Client was vaccinated with Pfizer Covid vaccine on 3/19 and 4/9/2021.  He tested positive for Covid with symptoms on 8/11/2021.  Symptoms: difficult breathing x 1 day, fever x 2 days, loss of smell and taste.  VAERS report submitted because this is a case of Covid in a previously fully vaccinated person.
Pt said he experienced rash over his stomach area several days after receiving the high-dose flu vaccine. Rash lasted for approximately 10 days. Pt cannot think of any other possible cause for the rash.