chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Each time I was extremely itchy on my scalp and in all joint areas; peri-orbital redness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN. Past drug history included: Neomycin for Known allergies: Neomycin. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "peri-orbital redness", "Each time I was extremely itchy on my scalp and in all joint areas"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "peri-orbital redness", "Each time I was extremely itchy on my scalp and in all joint areas". The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "Each time I was extremely itchy on my scalp and in all joint areas"; ERYTHEMA (non-serious), outcome "recovered", described as "peri-orbital redness".  Additional information: The patient received more than 3 doses. 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 vaccine. Each time patient was extremely itchy on scalp and in all joint areas. Itching lasted for several hours. Patient also had peri-orbital redness each time. Adverse event start date/time was also reported as 09Mar2021 at 12:00 PM.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325408 same reporter/patient/event, different vaccine dose;US-PFIZER INC-202201325409 same reporter/patient/event, different vaccine dose;
Several days prior to the shot, I had been experiencing sore, muscle-related pain in my neck, especially the left side and shoulder area, making it difficult to turn my head to the left. I was still experiencing this pain at the time of the shot. The evening of receiving the shot, I awoke at about 11:30 p.m. with extreme pain in my left shoulder (would describe as 8 on scale of 1 to 10)...not sure I could even get out of bed. Was able to "walk it off" and went back to bed, but had the same pain and difficulty getting out of bed twice more that night. Once prone, the pain would eventually subside. Went to work that morning (the day after receiving the shot) but returned home after an hour as I had a mild fever (100.1) and chills. I took 2 Ibuprofen and slept for about 2 hours. I awoke with temperature down to 99.7 and less pain in the left shoulder/arm area. Throughout the day, my temperature continued to go down and the chills lessened. Two days later, I have no fever and mild pain at injection site.
snotty nose; can't breathe well out of her nose; body aches; fever; This is a spontaneous report from a contactable consumer (Mother). This consumer reported for 2 patients. This report is for 1st of 2 patients. A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at age of 12-year-old) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient experienced fever of 102.1 on the first night on 15Jul2021, 101.1 the next day (16Jul2021), and since then has had a fever ranging from 99.3 up to 100. On 16Jul2021, the patient experienced snotty nose, can't breathe well out of her nose and body aches. The patient got vaccinated on 15Jul2021 and about an hour later the patient had a huge fever which the caller knew would happen. The patient was snotty, could not breathe well, and had body aches. Caller wondering if these side effects were due to the vaccine. Outcome of the event fever was recovering; snotty nose, can't breathe well out of her nose, body aches was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue; Chills; Off-label use; Booster dose; This is a spontaneous report from a non-contactable consumer. An elderly non-pregnant female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Oct2021 as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced fatigue and chills. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue and chills were resolved on an unknown date in Oct2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bilateral neck stiffness with limited mobility, nausea and vomiting.  Started next day and persisted. ER visit on 1/12 migraine cocktail and bilateral nerve blockers no assistance. Used anti-inflammatory meds, acetaminophen and Zofran for daily treatment. Progression of symptoms got worse occurring with double vision. Had ER visit after several test listed below diagnosed with aseptic meningitis. Placed on pain killer and steroids treatment to subside symptoms.
Hard heart beat, but not racing heart beat within the first half hour and lasted until the early hours of the next morning. Metallic taste in back of throat that started within the first half hour and lasted until the next day. Muscle cramps and spasms throughout the first night from feet up to neck. Throbbing/pulsing pain in left arm (injection arm) from finger tips to neck. Intense pain started a couple hours after injection until the early hours of the following morning. Extreme fatigue, light headed, nausea started about 24 hours later and still experiencing two days later. (feels like a bad flu without the congestion or cough)
Patient called son around 6:30am on 2/18/21. When son tried to contact patient around 8:30am, he was not able to get a hold of patient. Son sent someone over to check on patient. They found patient on the floor. He was coherent at first but then lost consciousness. It believed he experienced a stroke sometime around 8:30-9:00am of 2/18/21. Patient was taken to hospital and then transferred to another hospital. He was put in a medically induced coma. He passed between 4:00 and 4:30 pm on 02/19/21.
Alert/Responsive. Medical Assistant  Administered peds Dose 0.2 instead  of adult Dose 0.3. No Adverse Reactions Noted. DOM & Family Notified
erythema noted @ inj site by father approx 48hrs p/vax;In ER 2 inches by 1/2inch sl swelling & tenderness @ site;father denies temp or other sxs;
couldn't move at all, was very sick; felt terrible; felt like a terrible flu in her body; CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (couldn't move at all, was very sick), DISCOMFORT (felt terrible), INFLUENZA (felt like a terrible flu in her body) and ACCIDENTAL OVERDOSE (CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose). On an unknown date, the patient experienced ILLNESS (couldn't move at all, was very sick), DISCOMFORT (felt terrible) and INFLUENZA (felt like a terrible flu in her body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Oct-2021, ACCIDENTAL OVERDOSE (CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose) had resolved. At the time of the report, ILLNESS (couldn't move at all, was very sick), DISCOMFORT (felt terrible) and INFLUENZA (felt like a terrible flu in her body) was resolving.            No Concomitant medication details were provided.   Reporter did not allow further contact
rash occurred on a recent surgical wound/rash developed on the back crease of her legs and neck/severe rash that got worse/general practitioner got steroids to help with itching; This is a spontaneous report from a contactable consumer.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration to left arm from 02Jan2021 to 02Jan2021 as SINGLE DOSE for COVID-19 immunization.  Medical history included spinal surgery and surgical wound, a 7 inch scar along her back/she had spinal surgery and has a 7 inch scar, she had no problems.  There were no concomitant medications. The patient reported a rash that developed after receiving vaccine on 02Jan2021.  On 03Jan2021, her rash occurred on a recent surgical wound, a 7 inch scar along her back.  The rash also developed on the back crease of her legs and neck.  She has been managing her symptoms with Benadryl. The patient was asking is others has reported this side effect. The patient is also asking if she can get the second dose of the vaccine. Her surgeon suggested perhaps not receiving second vaccine. It was further reported as, "got Pfizer COVID-19 Vaccine on Saturday. Next day had a severe rash that got worse. Saw her general practitioner this morning and got steroids to help with itching. No further details provided, wants to know if she should forgo the second shot. The patient stated she was fortunate to get the Pfizer vaccine, later clarified as Pfizer COVID vaccine, Saturday in the early am, then on Sunday, developed a rash over part of her body, she can control with Benadryl, the itching, but the weird part, is a month ago, she had spinal surgery and has a 7 inch scar, she had no problems, like no reaction to glue, but the rash is concentrated down both sides of the scar. She had an appointment with her surgeon today, and showed it to him, since she thought it was unusual, and he said she may not want to take the second dose, it was not a terrible rash all over her body, mainly concentrated to the area of her back, and it is like a little bit on the back of her neck, not even anything she would notice, but it is there. The patient stated she can't get through to the Health Department, and she has a card to say to have the second dose on 23Jan2020, but she can't get through. States thanks so much, this is a miracle event and in a year's time, even if she did get a rash. The rash is a little more pronounced, but she has been rubbing it trying to not scratch, but it doesn't seem to be spreading any at all. States she is healthy. Seeking more information about getting the second dose after experiencing a rash. The outcome of the event was unknown.
Slight dizziness.  Arm very painful.  Expected this due to implications on info sheet.  About 5:30 pm very cold.  Took Motrin about 6:30 and went to bed.  Next day feeling better, but arm still very painful.  Dizziness gone.  About 08:00 PM noticed arm swollen and red splotches under shot and down to elbow on the underside of arm.  Shoulder sore.  Took Motrin again and went to bed.  Better on Sunday.
Mother of child states that the child had a subjective fever on 10/26/2020, she did not take his temperature, but he felt hot to the touch. States she believed his was teething at the time, as he is cutting new teeth. 2 days later around dinner time (6:00pm) mother states child's eyes rolled into the back of his head, his eyes glassed over and his body was limp. States when she picked him up, his arms hung to the side. Mother estimates the seizure event last 10 minutes. She drove the child to the ER and by the time they got there he was his usual self.
Pt called 1/10, reporting having symtoms of Shingles.  Rash, itchy, pain on opposite side of shot, under breast, unilateral around to back. Going to see PCP.
headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient stated that he received first dose of the Pfizer vaccine a few weeks ago and experienced headache. The outcome of the event was unknown.   Information on Lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
pt recvd vax; t 104; tx APAP & sponge bath; left leg hot to touch & slightly swollen, very tender;
Dehydration; This spontaneous case was received on 06-Aug-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-01546) and concerned a female patient of an unknown age. At the time of initial reporting, the patient was a 45-year-old.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in the past, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, anatomical location, route of administration: not reported). The batch number was not reported. The patient did not know the name of the vaccine or lot number or expiration date.  On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced severe dehydration and was admitted to hospital due to the event.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of 'dehydration' was assessed as serious due to criterion of hospitalization.  This case is linked with case 202102845 (due to the same patient).  Company Comment: A female patient developed dehydration after vaccination with the suspect product influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history and related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality is unassessable.; Sender's Comments: A female patient developed dehydration after vaccination with the suspect product influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history and related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality is unassessable.
Headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 18Aug2021 (Lot number: FA7484) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "C-section", start date: 08Jan2014 (unspecified if ongoing), notes: she had 4 c-sections with spinal taps ; "Lost taste", start date: Jun2021 (unspecified if ongoing); "Lost taste and smell at the time", start date: Jun2021 (unspecified if ongoing); "Heart ablation", start date: 2017 (unspecified if ongoing), notes: She had heart ablation on 2017; "Gall Bladder removal", start date: 2017 (unspecified if ongoing), notes: She had Gallbladder removal on 2017; "C-section", start date: 30Dec2015 (unspecified if ongoing), notes: C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020; "C-section", start date: 30Jun2018 (unspecified if ongoing), notes: C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020; "C-section", start date: 12Jun2020 (unspecified if ongoing), notes: C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020; "covid", start date: Jun2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "Headaches". The event "headaches" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: she had 4 C-sections with spinal taps which could be damaging to the nerves. C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020. States they are different headaches and not the not the normal type of headache, it feels like it is her nerves. Thinks one dose was in left arm and other dose was in the right arm but she is not sure, she just knows it was in her arm. Headaches are every week, around 3 days a week, it is really intense, usually above or around temple. Treatment: patient takes Tylenol and Ibuprofen and they are not really working which is why she thinks it is a different kind of head pain. Confirmed she was not admitted. Patient stated she will follow up with doctor tomorrow since headaches are not going away.  No follow-up attempts are possible. No further information is expected.
Child received KINRIX in left thigh on 29 AUG 2018. Mom reports that site hurt the following day and by the end of the day, child's thigh was swollen and red and warm to touch. No fever or change in activity per Mom. Today, 2 days after immunization, left thigh very swollen and remains red and warm to touch though no define area of induration. No fever and child remains active. No availability in clinic for patient to be seen by provider so sent to Urgent Care for evaluation.
LEFT eye: "on fire" pain in left eye and lateral to orbit. COntinues to have pain, but improved after 4 weeks and now 5/10.  Hx of LEFT eye surgery for cataract removal and has had vision issues since. RIGHT hip: severe pain. After one day had shooting pain to RIGHT ankle. 4 weeks later has numbness and tingling.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications were reported. No observable changes in the patient occurred after administration of the expired FLUMIST. The product expired on 18-Dec-2011. On 20-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 30-Jan-2012: the reporter stated that the patient did not experience any late occurring adverse events with the expired dose of FLUMIST.
Beginning a few hours after the injection and throughout the following day:  pain/soreness at injection site, pain and swelling under my left armpit, malaise, fatigue The second day after the shot, the pain was lessened, but there was still swelling under my armpit.
Patient went to ER the day after the vaccine was administer for fever and rash. Follow up in our office for redness on right thigh today 6/30/23. Patient is being treated with antibiotic for cellulitis
I was vaccinated Monday evening 3/8. On Tuesday I noticed a small rash on my left arm around the elbow area. By Tuesday evening it had spread over most of my left arm. When I woke up Wednesday 3/10, the rash had spread to my stomach and upper thigh. By Wednesday evening, it haha spread to my chest, neck, back, and legs.
Patient experienced "excruciating" paint radiating from inside muscle all the way to tips of fingers. Patient stated fingers turned "colors" as well. This occurred approx. 3 hours after the shot and last over night. The pain lessened  over the next several days. By the time she reported the incident to the pharmacy on 12/24/2019 the pain had subsided all together and there was no physical abnormality. She had no reaction to the first shot.
Discharge Provider: Medical Doctor Primary Care Provider: Doctor of Osteopathic Medicine Admission Date: 7/27/2022 Discharge Date: Jul 29, 2022  PRESENTING PROBLEM: Respiratory failure   HOSPITAL COURSE: Patient is a 74-year-old male with a past medical history of chronic obstructive pulmonary disease,  hypertension and bipolar disorder who presented with acute sudden shortness of breath. In the ED, he was noted to be hypoxic requiring supplemental oxygen via nasal canula. He was also noted to be hypertensive ultimately requiring nitroglycerin ggt. Troponins were also elevated on admission with no EKG changes or chest pain. This was thought to be due to demand ischemia. ECHO was normal. Blood pressure was stabilized and patient was taken off drip fairly quickly. He was started on Norvasc. He was also taken off oxygen and was stable on room air. He was discharged home in stable condition.
Pt. states that after receiving the 3rd dose of Phizer 01/17/2022, started experiencing symptoms 01/24/2022 of swelling in the right calf. Primary visit 01/31/2022 MRI/Vascular Ultrasound preformed locating 3 Blood Clots (Superficial), prescribed Baby Aspirin/ Elaquix for 3 months treatment. Follow-Up appt. after 2 months of treatments.
I felt fine the day of and in the evening.  woke to ringing in my left ear the next morning.  very slight nausea.  By the evening ringing has become very loud and almost have lost the hearing in the left ear.  noises in the right ear sound unusual.  The ringing has stayed the same on day 2.  very loud.  Those are the only two side effects so far.
The pt experienced hives on her face, arms, feet. The pt's face was flushed and the pt was wheezing. Benadryl was given. The rash increased and the wheezing became more pronounced. Mother later stated that hte child ate shrimp 30 minutes prior to the event, mother took the child to the ER for evaluation. Mother reported that the child had another reaction the following day.