chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The two big toes where swollen, red and painful underneath; four toes on each feet developed dark red spots on top/ fourth toes each were darkish red and also had the dark red spots on top; This is a spontaneous report from a contactable 75-year-old female consumer reported for herself that.  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:00 as (At the age of 75-years) dose 1, single for covid-19 immunisation. Medical history included sleep apnoea syndrome, and obesity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took clindamycin and experienced drug hypersensitivity. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient did not diagnose with COVID-19 Prior to vaccination. Patient was not been tested for COVID-19 Since the vaccination. It was reported that on 09Feb2021 13:00, 3 days after the vaccines, four toes on each of his feet developed dark red spots on top. The two big toes where swollen, red, and painful underneath. The fourth toes each were darkish red and also had the dark red spots on top. Patient was visited Doctor or other healthcare professional office/clinic for the events. Patient did not receive any other treatment for the events. The events were assessed as Non serious by reporter. The outcome of events was recovering.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Developed a swelling and induration at right arm injection site. Size 5"x3". Possible cellulitis.
palpitations; tingling in hands; tingling in left side of neck/ tingling in left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), PARAESTHESIA (tingling in hands) and PARAESTHESIA (tingling in left side of neck/ tingling in left side of neck) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], BISOPROLOL, VITAMIN D NOS, VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations), PARAESTHESIA (tingling in hands) and PARAESTHESIA (tingling in left side of neck/ tingling in left side of neck). At the time of the report, PALPITATIONS (palpitations), PARAESTHESIA (tingling in hands) and PARAESTHESIA (tingling in left side of neck/ tingling in left side of neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI
I was 6 years cancer free, from head and neck cancer. Did the Moderna vaccine have anything to do with bringing it out of remission?  My cancer returned may 2021
At 11:51 AM, RN administered 0.1cc dose of Jynneos vaccine Lot # FDP000014 exp date 11/17/2022 via intradermal route to left arm to patient  age 30 and a wheal was not produced. RN notified clinic lead nurse, PHN regarding incident and per clinical guidance was instructed to give a 2nd dose. Patient requested to get 2nd dose on left arm. Educated patient that because no wheal was produced, a repeat dose must be placed to the other arm or 2 inches away from the 1st dose. Patient verbalized understanding. RN re-administered another dose of 0.1cc of Jynneos Lot #  FDP000014 exp date 11/17/2022 left arm and a wheal was produced. Patient was educated to observe for adverse reactions.
Patient called morning of 10-7-08 complaining of pain and numbness in left arm.  Patient states pin started that afternoon after she received shot.  Pt called doctor who instructed her to take BENADRYL and DARVOCET for pain.  Patient stated she saw physician who gave her a "shot" for pain and pain  was relieved
body aches; feels feverish; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 26-JUL-2023, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches) and fever (Verbatim: feels feverish). The outcome of the general body pain and fever were not resolved.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.     It was unknown if the company considered the general body pain and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUL-2023 The reporter reported that a patient received his first Shingrix dose yesterday, 25-JUL-2023. On the day of reporting, he felt feverish and had body aches. The reporter did not consent to follow up.
Patient stated that she went to sit down , sat on the tip of the chair and fell to the floor.  Patient had no respiratory distress , no loss of consciousness, but cut her left elbow. Elbow cleaned and bandage. Patient had  a neck brace due to falling 5 weeks ago and fracturing her spine per patient.. Patient refused other medical care-didn't want paramedics called.
I exp stiffness right arm(not able to raise my arm above shoulder length). I felt as if more pain than the 1st dose.
unusual intense cramping; Early period; extended period; spotting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 12:00 (Lot number: ewo183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gerd" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: NEXUS [AMLODIPINE]; VITAMIN D [COLECALCIFEROL]; IRON. The following information was reported: DYSMENORRHOEA (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "unusual intense cramping"; MENSTRUATION IRREGULAR (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "Early period"; OLIGOMENORRHOEA (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "extended period"; INTERMENSTRUAL BLEEDING (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "spotting". Therapeutic measures were not taken as a result of dysmenorrhoea, menstruation irregular, oligomenorrhoea, intermenstrual bleeding. Additional information: Reaction/event as reported by primary source: Early period, extended period, spotting, unusual intense cramping. Happened to the reporter herself and daughter at the same time after vaccine. No prolonged hospitalization and no treatment received. Facility where the most recent COVID-19 vaccine was administered was available. Start Date/Time: Pfizer 2Aug2021 12:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Known allergies to penicillin.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110884 Same Vaccine/event, different  patient.
Patient presented to the clinic with left upper arm redness (10x8cm), warm and tender. Temp=99.3 (ear). (2 days after administration). No treatment - Told to return if worsening redness and pain, or drainage noted.
headache, nausea, chills, gastrointestinal - gas and sudden need to poop.  symptoms lasted from about 6 hrs after the vaccine, that night, next day and into the next night.
Onset at 8:50 pm 10/22/2021.  Extremely achy muscles, (not joints) on backs of legs, arms, shoulders. Intermittent nerve pains overnight, not like an electrical impulse but running along a nerve for 2-3 inches and relieving before I could respond, not localized in one place, random over body and face, weak, loss of appetite, smelling of cigarette smoke ( no smokers in house or on or near premises, but definitely the smell of cigarette smoke, intermittently, through night.) Restless sleep.  No fever or chills but cold.  Symptoms started mitigating at 9:00am on 10/23/2021 and resolved by 1:00 pm, and regained strength until fine on 10/24/2021.
Shingles, had both shingles shot/ suspected vaccination failure; shingles, had surgery, scar on side of head, went to ear; Shingles went to ear; eye looked like somebody had punched me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included surgery (head surgery). Concurrent medical conditions included scar (scar on the side of head where the patient had the surgery).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, herpes zoster oticus (serious criteria GSK medically significant) and black eye. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, herpes zoster oticus and black eye were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, herpes zoster oticus and black eye to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she was getting over shingles now and had a scar on the side of head where he/she had the surgery, that was where shingles started then went to ear. The next day, the patient's eye looked like somebody had punched him/her. The patient immediately went to the eye doctor and the doctor asked if patient had received the Shingles shot, to which the patient replied that he/she had both the shots.  The doctor checked the patient's eye and it wasn't in eye but he said, the patient had shingles.  The patient was still taking the anti viral, the doctor had prescribed. The patient stated that, before he/she knew what he/she had, the patient thought he/she was going to scratch the head off.  The patient would get the simple Super B complex, and was asking where to purchase this. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting.
- Covid arm on 11th day after 1st shot, size 3" x 1 3/4", swollen and itchy.  Took Zyrtec, resolved in 4 days. - Mild fever but intense full body pain for 2 full days after 2nd shot. - Delayed adverse reactions starting 7/13/2021 ; neuropathy : electric zaps, pins and needles, numbness, muscle spasm and twitches.  Started 1st at feet and legs, then up to thighs and groin, then arms and body, also face and lips.  Guillain barre variant? Doctor checked B12 and thyroid, normal. - 8/20/2021 ; 2 lumps developed at arch of feet = location of 1st electric zaps. - November : vascular problems - mini blood lumps appear on finger after some pressure, eg. twist-drying kitchen towel.  In July, many spider veins appeared (doc thought not related to vaccines.  I think it's related).  Symptoms still progressing now.
Muscle aches; Sweats; Severe fatigue; Sides ache; I can feel every hair on my body throbbing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 18:00 (Lot number: FA7485) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FA6780, Administration time: 05:15 PM, Vaccine location: Left arm, Dose number: 1), administration date: 22Jul2021, when the patient was 58 years old, for COVID-19 Immunization.The following information was reported: MYALGIA (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Muscle aches"; HYPERHIDROSIS (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Sweats"; FATIGUE (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Severe fatigue"; PAIN (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "Sides ache"; FEELING ABNORMAL (non-serious) with onset 13Aug2021 08:00, outcome "not recovered", described as "I can feel every hair on my body throbbing". Therapeutic measures were not taken as a result of myalgia, hyperhidrosis, fatigue, pain, feeling abnormal.  Additional information: Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Seriousness reported as No.  Follow-up attempts are completed. No further information is expected.
Friday, throat felt "on fire"-mucous, sinus, nose, throat clear, on occasion yellowish. Increased salivation-for 2 wks->to be a rest: dry->productive cough. Exhaustion.
Patient experience mild rash. Got over the counter medications to help with the itch. Will follow up with doctor in near future if doesn't resolve.
Itching all over his body/itching presented on his feet and toes; Feels a burning on his face that comes and goes; His face gets red in color; His head, back and legs are scratched; itching on his testicles; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 94-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer. Concomitant products included antineoplastic agents (nos) (Anticancer Agent (Nos)).   In 2019, the patient received the 2nd dose of Shingrix. On 17th September 2019, less than 9 months after receiving Shingrix, the patient experienced genital itching male. On an unknown date, the patient experienced generalized pruritus, burning sensation, red face and scratch. On an unknown date, the outcome of the generalized pruritus and red face were not recovered/not resolved and the outcome of the burning sensation, scratch and genital itching male were unknown.   It was unknown if the reporter considered the generalized pruritus, burning sensation, red face, scratch and genital itching male to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in either March or April and following that dose he has developed itching all over his body. His head, back and legs are scratched from him scratching them.The itching presented on his feet and toes just recently and before the date of reporting he complained of itching on his testicles. He feels a burning on his face that comes and goes.When it presents, his face gets red in color. There was no rash present with this itching. The reporter consented to follow up.
High Blood Pressure; High Blood Sugar; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure) and BLOOD GLUCOSE INCREASED (High Blood Sugar) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included INSULIN for Diabetes.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERTENSION (High Blood Pressure) and BLOOD GLUCOSE INCREASED (High Blood Sugar). On 04-Feb-2021, HYPERTENSION (High Blood Pressure) and BLOOD GLUCOSE INCREASED (High Blood Sugar) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Pt Stood up after vaccine from exam table; and passed out. As A result pt fell face first and hit face on ground. Pt has laceration above (R) eye brow. Pt needed stiches (5-6) above eye brow.
On Tuesday at lunch, I didn?t realize that something I was eating (hummus) was burning my tongue. Didn?t think anything about it. Tuesday evening, I spent the evening outside and we were painting. When I got home, my throat started getting sore and I had a paint smell in my nose. When I woke up on Wednesday, my throat was really sore. I figured it was maybe because I was out in the pollen. I took an antigen test just to be safe. I took it and left it on the counter to go to work. My husband took a picture and sent it to me and it was positive. I called my employer and said I wouldn?t be coming to work and turned around to go home. By the time I got home, I was experiencing diarrhea and then my nose continued to hurt and run. My throat was scratchy. Ears were hurting. Headaches and body aches. No fever. Today and last night, sweats, chills, and waking up this morning very weak and nauseous. My temperature this morning was normal. that?s it ? headaches, body aches, chills, sweats, sore throat, and ears. I do have certain foods that also make it feel like my tongue is burning. I don?t have the paint smell in my nose anymore, but it is still stuffy and congested.
was administered the first dose of GARDASIL 9 when she was 13 years old/was then administered a second dose of GARDASIL 9 when the patient is now 19 years old; No adverse effects were reported; Information has been received from a nurse, referring to a 19 years old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided.   On 15-AUG-2013 (reported as when she was 13 years old), the patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, lot# and expiration date were unknown) intramuscularly for prophylaxis. On 19-JUN-2019, the patient was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose and strength were unknown; lot# was reported as 1614897 and expiration date 20-SEP-2021) intramuscularly for prophylaxis (inappropriate schedule of product administration).  No adverse effects were reported.
Home antigen test was strong positive/Developed fatigue and congestion; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Home antigen test was strong positive/Developed fatigue and congestion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Seqirus Quadrivalent Influenza Vaccine (Seqirus Quadrivalent Influenza Vaccine 2016-2017) from 2016 to 2017. Past adverse reactions to the above products included Allergy with Seqirus Quadrivalent Influenza Vaccine. Concurrent medical conditions included Hypertension.    On 03-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022 at 5:00 PM, the patient experienced COVID-19 (Home antigen test was strong positive/Developed fatigue and congestion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Home antigen test was strong positive/Developed fatigue and congestion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Strong positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment with Paxlovid. It was further reported that today, on 18-May-2022, four days after completing the course of Paxlovid, the patient had developed fatigue, congestion and at the patient home antigen test was strong positive. No treatment medications were reported.  Company comment- This spontaneous case concerns a 43-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred 6 months and 15 days after vaccination with a third dose of mRNA-1273. The patient experienced Covid-10 and took Paxlovid. 4 days after completing his course of Paxlovid, the patient developed fatigue and congestion. The home antigen test done was positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred 6 months and 15 days after vaccination with a third dose of mRNA-1273. The patient experienced Covid-10 and took Paxlovid. 4 days after completing his course of Paxlovid, the patient developed fatigue and congestion. The home antigen test done was positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
fever of 101.2 extremely weak, shivers & shaking, throat swelled up; no problems breathing; thinks it is a sore throat; lasted 11 hrs; feels beter; 1st dose w/o problem; 9 hrs p/2nd dose got ill; 21SEP92 f/u blood drawn for titer check;
tired, numbness, cramps, stiffness, pain, joint pain, lung pain, swelling at lymph nodes.  i have not been to a treatment, i don't speak the language. it started after the first dose and was worse after the second. ongoing.
He had exhibiting a runny nose with a wet cough and had a brief fever that was 10 minutes in duration. We did a at home COVID-19 test which was negative and we took him to the night clinic and they administered a flu test COVID-19 test, Strep test and all were negative. He was diagnosed with a common cold along with an ear infection. Treatment that was provided was only amoxicillin antibiotic.
Patient said she felt drowsy and malaise for 24 hours after the vaccine, then on 1/15/2020 she started to develop an irregular shaped rash on her vaccinated arm. The rash grew to double the size by mid day 1/16/2020 and was warm to the touch and red/erythmetous. Pharmacist suggested patient see nurse practitioner at urgent care clinic in our pharmacy location.