chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Raised rash all over body; Raised rash all over body. Hot and very itchy. Raised rash all over body. Hot and very itchy. This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 06May2021 at 07:45 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 12:45 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. On 08May2021, the patient had raised rash all over body, hot and very itchy. 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 events raised rash all over body and hot and very itchy was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
'Flu like' symptoms for two days, left arm pain, hot to touch, itching, swollen, and red  on days 2 - 4, swelling, heat, and pain diminished but redness, itching still remain on day 7. Blood pressure raised and dizziness on days 3-4
Injection site pain; dizziness; swollen lymph nodes; joint pain; headache; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), DIZZINESS (dizziness), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 57-year-old male patient 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), DIZZINESS (dizziness), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint pain), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (Injection site pain), DIZZINESS (dizziness), LYMPHADENOPATHY (swollen lymph nodes), ARTHRALGIA (joint pain), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided      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.   Treatment information was not provided. /unknown.  Concomitant product use was not provided/unknown by the reporter.
Fatigue for 14 days Skin rash continuing to present. Dizziness intermittent for 14 days.
SYNCOPE: CLAMMY/SWEATING, PALENESS, NAUSEA
Taken to ER for fussiness, looking to the left, arching back and poor feeding. Her temperature was 37.9C.
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: Patient stated that she has a history of fainting after vaccines.  Immediately after she felt lightheaded and then a couple mintes after she fainted for a few seconds.  A couple minutes later she vomitted. She stayed seated for several minutes until feeling better.
Pt first developed numbness and tingling of the lips which was followed by very slight upper lip swelling.  This numbness and swelling improved without intervention but over the next 10 mins returned but this time with swelling of the lower lips.  Pt has h/o atrial thrombus as well as reaction to epinephrine (drooling, tachycardia, unsteady gait).  Benadryl 50 mg given in hopes that this will slow the reaction while patient was transported to the ER.  While epinephrine was indeed warranted this was not provided given her comorbidities and prior reaction to epinephrine.  Patient with stable vitals, no dyspnea.  Ambulatedto the Ambulance without difficulty.
Extremely minor or little pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Extremely minor or little pain at injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Extremely minor or little pain at injection site). At the time of the report, INJECTION SITE PAIN (Extremely minor or little pain at injection site) 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.
January 2020 /uncomfortable feeling progressed to a burning sensation; painful when touched; had to sleep on her stomach only; and couldn't ride her stationary bike; uncomfortable feeling progressed; uncomfortable feeling progressed; This case was reported by a consumer via call center representative and described the occurrence of burning leg in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of limb discomfort (1st dose received in October 2019, refer case US2020203023). Concurrent medical conditions included dizziness. Concomitant products included gabapentin.   In December 2019, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 months after receiving Shingrix, the patient experienced burning leg, tenderness, sleep disorder, decreased activity, leg discomfort and condition aggravated. On an unknown date, the outcome of the burning leg, leg discomfort and condition aggravated were not recovered/not resolved and the outcome of the tenderness, sleep disorder and decreased activity were unknown.   It was unknown if the reporter considered the burning leg, tenderness, sleep disorder, decreased activity, leg discomfort and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient had been taking 300 mg gabapentin every 4 hours which causes some dizziness. The patient received 2nd shot of Shingrix in left arm. By January 2020, the uncomfortable feeling progressed to a burning sensation that felt like a bad sun burn that was painful when touched. It was to the point where she had to sleep on her stomach only and could not ride her stationary bike. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203023:same patient (1st dose)
sudden right hearing loss; sudden right hearing loss; bilateral sensorineural hearing loss; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.  On or around 21-OCT-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot number, dosage, and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), the pt suffered sudden right hearing loss and bilateral sensorineural hearing loss and had multiple intratympanic dexamethasone perfusion procedures to no avail. As a direct and proximate result of zoster vaccine live(ZOSTAVAX),the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Sudden hearing loss, deafness unilateral and deafness neurosensory were considered to be disability.   Upon internal review, sudden hearing loss, deafness unilateral and deafness neurosensory were determined to be medically significant.
Shortness of breath, weakness, blurred vision, tiredness, generalized aches and pains, legs are tired
muscle in the right arm started to hurt.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982) via an unspecified route of administration in right arm on 23Jan2021 09:00 at single dose for COVID-19. Medical history included rotator cuff surgery on her left arm on 28Dec2020 that was affected by a flu shot that she just got (sore left arm Flu vaccine, 26Oct2019-27Oct2019), chronic lymphocytic leukaemia (CLL) (had it 20-25 years ago stated that she watches her white blood cell count on it). Family medical history relevant to AE was none. No vaccine was received within four weeks. There were no concomitant medications. The patient experienced muscle in the right arm started to hurt on 24Jan2021 17:00. She put ice on it as treatment. Relevant tests were none. The event didn't require Emergency Room visit or Physician Office visit. The outcome of event was not recovered.
after the vaccine she is only getting like 2 good days out of her infusions, making the infusions not help now; after the vaccine she is only getting like 2 good days out of her infusions, making the infusions not help now; severe lethargy and malaise; severe lethargy and malaise; severe neck pain; smells things burning; no appetite; tinnitus in both ears; chest pains; lost a lot of weight; This is a spontaneous report from a contactable nurse (patient).   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization  .  Medical history included ongoing Primary immune deficiency disease diagnosed around 2017. States she has multiple drug allergies, no further information provided. Concomitant medication included immunoglobulin human normal (GAMMAPLEX) taken for an primary immune deficiency disease from 2018. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization Patient state she was lethargic and had severe malaise, she had severe neck pain and had to ice things, states she smells things burning all the time, the house burning, toast burning, stopped checking because she knows it was just a symtom, she had no appetite, had tinnitus in both ears and now it is unbearable, can barely hear because it is so loud in both ears, has chest pains that she has never had before, and states  after the vaccine she was only getting like 2 good days out of her infusions, it had decreased the effectiveness of the infusions, used to get a good 10 days after the infusions, now she only gets 2. States she has lost a lot of weight as well since the second dose of the vaccine, used to be 175.  The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna 3/24/21, 4/22/21, 15/15/21. Positive on 4/10/22
Started seeing blisters; Diagnosed with shingles by the typical skin presented in lower abdomen, right side of the waist and the back area at waist level; More and larger red rash surfaced; felt burning on the skin in lower abdomen; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included a mild degree of diabetes which was under control and the patient had no autoimmune diseases, was a non-smoker and was not an alcohol user. The patient had no allergies to medications, food, or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 20:00, after the first dose, the patient felt burning on the skin in lower abdomen with fatigue. On 12Apr2021 and 13Apr2021, the following 2 days, the affected areas grew wider and spread to the right and her back; more and larger red rash surfaced. On 14Apr2021, the patient started seeing blisters, so went to see a doctor, and told her it might have resulted from the first dose. On 14Apr2021, the patient was diagnosed with shingles by the typical skin presented in lower abdomen, right side of the waist and the back area at waist level. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with valacyclovir 1 gm three times a day for seven days. On 15Apr2021, the patient read an Israel report which came up indicating shingles events having a possible link to the vaccine and the patient wanted to know if she could skip the second dose which was scheduled on 05May2021. Her shingles would not be fully recovered before the second dose and she wanted to know what was the maximum interval allowed between dose 1 and dose 2 to maintain the desired efficacy. She also asked if skipping the second dose would impact Pfizer upcoming variants boost dose on efficacy. She also asked if she can receive other company's second dose or a booster if she planned to skip Pfizer's second dose. The clinical outcome of the events burning on the skin in lower abdomen with fatigue, red rash, blisters and shingles were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Finely scattered rash over a period of 3 days & temp. pt mother just observed rash no treatment. Rash resolved.
Wobbly; gate problem; balance problem / his body was out of balance; back pain/he can no longer bend over to put on socks; waking up at night; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks) and SLEEP DISORDER (waking up at night) in a 74-year-old male patient 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks), SLEEP DISORDER (waking up at night) and FATIGUE (Felt fatigue). At the time of the report, DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks), SLEEP DISORDER (waking up at night) and FATIGUE (Felt fatigue) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.  Patient was can no longer bend over to put on socks      Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up received contains no new information.
That evening my arm swelled up and became very painful - not as much as the first vaccine. I had a hard time sleeping - nausea and headache throughout the  night. 4/3 - extremely tired; felt like I couldn't get enough air (shortness of breath) body aches and muscles aches - over all lethargic. 4/4 - I was dizzy, short of breath . Those two symptoms lasted along with fatigue - which lasted for two days. I almost passed out that day - everything went black and I had to be assisted to the couch to recover from that.  I used Tylenol for my symptoms when needed.   I still have ongoing headaches - three weeks ago (about a week after I got the vaccine) - I noticed I was having ongoing headaches and I still have these.  Pregnancy - 2nd pregnancy; 1st one was full term. Date of delivery expected - September 9, 2021.
PATIENT STATED THAT HER ARM HAS BEEN SORE EVER SINCE SHE RECEIVED VACCINATION. SHE COMPLAINED THAT SHE HAS TROUBLE LIFTING HER ARM TO PUT ON AND TAKE OFF HER BRA AS IF SOME NERVE PROBLEM EXISTS.
Pt was trying to conceive at appt 7/7/2015, with LMP of 6/20/2015. Gardasil 9 was given on 7/7/2015, and pt subsequently conceived to be currently pregnant, EDC of 3/26/2016. This is an early pregnancy exposure reporting.
This spontaneous report was received from a consumer concerning a patient of unknown age and gender (consumer's friend). No medical history reported. On an unspecified date, the patient had an active case of wild-type shingles. It was reported that while the shingles was still in the active phase, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, strength, lot and expiration date not provided). The consumer reported that her friend's shingles symptoms seemed to get worse. At the time of the report, the outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Patient tested positive for Covid19 eve after being vaccinated with Pfizer vaccine 04-29-2021  05-20-2021
It was reported that a 46 year old female received a Fluzone UNSP '99-'00 vaccination on 11/11/99. Reportedly, 6 hours, post vax, the pt developed a rash on her chest. Three days later, the rash began to itch.
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021 at 11:49 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.
Pt was given covid vaccination, then moved from exam room to waiting room. Pt was sitting in waiting room chair, was leaning forwards, then leaned back. Pt then stated "Oh no" and this nurse asked if he was okay, at this time pt became unconscious et leaned to the left, fell out of the chair et hit head on floor, laid on left side. This nurse hit emergency call button, then went over to patients side, while other nurses responded. Pt was pale in color, skin temp warm et pt was diaphoretic. Pt then rolled from his side to his back, et woke up, pt was confused upon first waking, but was then able to tell us his name, et where he was and what he was doing. It was noted that pt had some blood in his mouth, from hitting floor. While pt was laying on his back, vs were taken. HR low, BP within normal range. Pt denied pain, denied SOA, but stated he was "hot, sweaty, and dizzy" pt then sat cross legged on floor. Given water to drink, noted to be shaky. Pt stated he was feeling better, but wanted to continue to sit on the floor. Pt stated when he first woke up, he was confused, because he thought he was at home sleeping. Pt was able to carry on a conversation with nurses. Pt then got up et sat in chair, stated he was cold and was shaking. Ceiling fan was turned off, et pt stated that felt better. After a while, pt walked around waiting room area before deciding he was stable enough to drive himself home.
A consumer report had been received concerning a 10 years old female patient. No medical history and concurrent diseases provided. Concomitant medications were not reported. On 17-Oct-2012 the patient was vaccinated with nasal FLUMIST and appeared to have little in the first nostril and a huge blast in the second nostril. The patient told that she didn't feel any in her first nostril. The action taken with FLUMIST was unknown. The report was considered to be non-serious by the reporter. Corrected report 15-Dec-2012: Event 'patient didn't feel any FLUMIST in first nostril' replaced with 'little in the first nostril and a huge blast in the second nostril', narrative updated, reporter details corrected. Corrected report on 16-Apr-2014: Drug and event start date added. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
first dose in sep 2020 never got the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020 (batch number erv5zb and expiry date 9th June 2021)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: HCP (Health Care Professional) reported that the patient received first dose of Shingrix in September 2020, never got the 2nd dose. The patient was immunocompetent. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Bottom lip went numb and right knee and right arm on his drive home. Went to ER, received Claritin and prednisone, no progression. Staff at ER told pt it was an expected reaction and to take Claritin at time of next vaccine.
2 inch area of erythema, warmth, itchiness to area around injection site of the flu vaccine.