chrisvoncsefalvay/vaers-outcomes huggingface dataset:
By 18Dec2022 she could hardly walk on her left leg; Pain in hip; administered in hip, left; administered in hip, left; Dose 5 / Third booster administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 5 (booster), single (Lot number: GJ327, Expiration Date: 31Jul2023) at the age of 71 years for COVID-19 immunisation. The patient's relevant medical history included: "Cancer" (ongoing); "Lymph nodes removed", start date: Nov2019 (unspecified if ongoing), notes: Other Conditions: Reporter later clarified details. She had cancer that had spread to the lymph nodes in both arms. Both of those lymph nodes were removed. The lymph nodes were removed Nov 2019.; "COVID", start date: 01Jan2021 (unspecified if ongoing), notes: She initially provided she had Covid 01Jan2020, but clarified it was 01 Jan 2021.; "Heartburn" (ongoing). Concomitant medication(s) included: LETROZOLE taken for neoplasm malignant (ongoing); ESOMEPRAZOLE MAGNESIUM taken for dyspepsia (ongoing). Vaccination history included: BNT162b2 (First COVID Booster (Dose: 3 Booster), Batch/lot number: EW0187   , Dosage text: 0.3ml administered in arm; unknown which one, Time Administered: It was given late afternoon; evening. Exact time unknown), administration date: 11Oct2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Hives", "Pain"; BNT162b2 (Second  COVID Booster  (Dose: 4 Booster) , Batch/lot number: FK9894 , Dosage text: 0.3ml administered in left arm , Second COVID Booster manufacturer: unspecified, NDC number of Second COVID Booster: Unknown, Expiry Date of Second COVID Booster: Unknown  , Time Administered: In the evening), administration date: 21Apr2022, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Hives", "Arm swelled even more with enormous hives", "Pain"; Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 17Nov2022, outcome "unknown", described as "Dose 5 / Third booster administered"; OFF LABEL USE (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) all with onset 17Nov2022, outcome "unknown" and all described as "administered in hip, left"; ARTHRALGIA (non-serious) with onset 18Nov2022, outcome "recovering", described as "Pain in hip"; GAIT DISTURBANCE (non-serious) with onset 18Dec2022, outcome "unknown", described as "By 18Dec2022 she could hardly walk on her left leg". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, gait disturbance. Additional information: The patient started physical therapy and it was helping.
I did not seek medical assistance for these symptoms. Approximately 4 hours after receiving the injection I felt my throat get very sore, and it felt like it was closing up. However, it did not reach the point that  I felt my breathing was hampered.  My eyes became very itchy and began to emit a thick mucous that would coat my eyes within minutes so I had to wipe it away in order to open my eyes.  After about 1 hour I felt the throat closing stop and the soreness began to lessen after a few hours.  The mucus from the eyes continued until about 2 am and then nearly stopped.  Today is Sunday at 7:15 PM  and my eyes are still itchy and red but are improving.  There is very little mucus being emitted from my eyes. On Saturday, the day after the vaccination, my knees were stiff in a way I have never felt before and remain a little stiff on Sunday.  I am athletic and do not have any problem with my knees.
I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
[Janssen COVID-19 VACCINE] use for COVID-19 under Emergency Use Authorization (EUA): PT found on bathroom floor on 11/11/21 @0900, vitals BP 77/50 HR 98. PT c/o crushing chest pain (unrelieved by nitroglycerin s/l) and shortness of breath; EMS was called and Pt was transported to ED; PT was admitted to hospital with the diagnosis of idiopathic pericarditis. PT hospitalized for 24 hours, discharged on Colchicine 0.6mg PO BID x14 days. PT re-admitted to our facility. PT received the J&J vaccine on 8/4/21. Lot# 201A21A exp date 9/21/21
Pt vaccinated with FLUZONE  4 hrs post vaccine developed continual cough, throat edema, bronchitis. Seen by LMD given Adrenlin & Ventolin inhaler. Sent to ER from MD & office and put on Prednisone pack for 2 day.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild
Tingling sensation on the left side, numbness, and stubbing chest pain. Enlarge lymph nodes, severe migraines, shortness of breath, heart palpitations, left-side temporal hurts.
typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is 9th of 17 reports. A patient of unspecified age and gender (reporter's friend) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness in Jan2021. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/product, diff AE/patients
Per chart note, pt developed redness at injection site, swelling and soreness in armpit. No chest palpitations or shortness of breath. Symptoms did improve some but provider recommended patient try heat to area and monitor for worsening symptoms. On 2/24/14 pt states symptoms calmed down but still has a red mark to the area where vaccine was given.
I have a very cyclical menstrual cycle. My last cycle was sue to start on 04/22 and to date, it has not started. I have never missed a cycle.
suspected vaccination failure/recieved the shot, still got shingles; shingles, settled in his left eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's father. The age at vaccination was not reported. The patient received a shingle shot and still got shingles. The reporter reported that they were horrible and they settled in his left eye. Shingles took several months for him to overcome. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pain @ inj site; pt described as the worst feeling shot ever had; dose was ordered & given SC, should only be given IM;
Chest pressure, hard time breathing, flu like aching/pains, headaches, loss of apetite,
local swelling/erythema @ site of DTP, poor appetite, vomiting, loose stools, inc sleeping, cries as if in pain;
Local hypersensitivity reactions measuring 2 inches or greater diameter of induration (swelling) constitute significant local reactions and are relative contraindications to future Influenza vaccination. This has been recorded in the allergy section of patient's chart. Please report this reaction to VAERS (Vaccine Adverse Event Reporting System)
COVID19  arm.  The site and area below injection began aching, swelling, redness  evening of 4/2.   Next day 4/03 the pain, swelling and redness increased, was also warm to touch.   4/4  pain swelling and redness increased.   Today 4/5 decrease in pain, swelling and redness, at the level of 4/03. I am a RN, I have daily photos if interested.
Patient presented 12/4/21 with new onset of multiple neurologic complaints; concerning for MS. Symptoms had started about 2 weeks before presentation. That was about 11 days post vaccination. Previously healthy patient with no prior neurologic complaints.   MRI on 12/11/21 consistent with demyelinating disease
Patient received a vaccine that was outside of recommended storage. Vaccine expired at 8:30 pm on the 27th and vaccine was given at 11:43 am on the 28th. Moderna was contacted and stated the patient should watch for signs of infection at the site. Patient called and did not have a reaction at this time.
Coughing, trouble breathing, fever 103.3 degrees, pulmonary edema, chest pain, vomiting.  Patient was immediately taken to the ER where he was put on a respirator.  He is currently in Intensive Care being monitored.
Patient was administered 1ml of Moderna vaccine instead of the 0.25ml booster dose.
Inflamed lymph nodes in the axillary area; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and had inflamed lymph nodes in the axillary area of the same side.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the event, the patient received their dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient had inflamed lymph nodes in the axillary area of the same side. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event inflamed lymph nodes in the axillary area of the same side was not recovered (still having inflamed lymph nodes in the axillary area of the same side).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
patient received 1st dose on 26 jan2021,second dose on 11 feb2021; patient received 1st dose on 26 jan2021,second dose on 11 feb2021; Hives; Facial swelling; Sore Arm; Lost voice indicative of airway swelling; Lost voice indicative of airway swelling; Extreme sleepiness indicative of low blood pressure; Extreme sleepiness indicative of low blood pressure; Fever - 102; This is a spontaneous report from a contactable consumer (patient). A 39 years old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 11Feb2021 at 14:00 as a 2nd dose, single dose for COVID-19 immunization. The patient's medical history included chronic urticaria, allergic to fire, ant bites, dog dander, dust mites. The patient's concomitant medications included lisdexamfetamine mesylate (VYVANSE), cetirizine (CETIRIZINE) and fexofenadine (FEXOFENADINE). Facility type vaccine was reported as Hospital. No other vaccine was administered four weeks prior to COVID-19 vaccine. On an unknown date in Dec2020, the patient underwent lab test and procedure which included covid test type Nasal Swab: Inconclusive. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 26Jan2021 at 14:00 as a 1st dose, single dose for COVID-19 immunization. On 12Feb2021 at 12:00 PM, the patient experienced sore arm, hives, lost voice indicative of airway swelling, extreme sleepiness indicative of low blood pressure, facial swelling and fever 102. The patient received 1st dose on 26 jan2021, second dose on 11 feb2021 (Inappropriate schedule of product administration)(Off label use) on an unspecified date. The patient underwent lab test and procedure post vaccination with COVID vaccine which include COVID test nasal swab: Inconclusive. The patient visited doctor or other healthcare professional office/clinic visit as result of the events. The patient took Epipen, prednisolone, antihistamines as treatment medication for the resulted events. The clinical outcome of the events were resolved on an unspecified date in 2021 and outcome of the patient received 1st dose on 26 jan2021,second dose on 11 feb2021 was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
passed out on the toilet; horrible sweats; sickest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS with onset Dec2020, outcome "unknown", described as "passed out on the toilet"; HYPERHIDROSIS (non-serious) with onset Dec2020, outcome "unknown", described as "horrible sweats"; ILLNESS (non-serious) with onset Dec2020, outcome "unknown", described as "sickest". Clinical courses: It was the sickest the caller has seen her since she was a little kid. Caller thought it was the Pfizer COVID vaccine that was administered.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Red rash covering head, face, arms and torso with some swelling to right upper arm.  Pt administered Benadryl 50mg by mouth and 0.15ml epinephrine subcutaneous Observed pt for approximately 45 minutes. No respiratory distress noted. Appt. scheduled with pediatrician 11/22/04 at 3:00p.m.
I began to get very fatigued about 3.5 hours after the injection on 10/21/19. Around 6 hours after the injection, I had a fever of 100.4 and the worst body/joint aches I've ever experienced. This lasted all that night and all the next day. (10/22/19) When I awoke on 10/23/19, the fever was gone but I still felt very fatigued. By the afternoon of 10/23/19, I felt pretty much back to my normal self.  There was no treatment other than fluids and rest.
Adverse food reaction; Appetite lost; Inflammation; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE FOOD REACTION (Adverse food reaction), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE FOOD REACTION (Adverse food reaction), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation) and HEADACHE (headache). At the time of the report, ADVERSE FOOD REACTION (Adverse food reaction) and INFLAMMATION (Inflammation) was resolving and DECREASED APPETITE (Appetite lost) and HEADACHE (headache) had resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. The reporter's causality for the event(s) of INCREASE IN INFLAMMATION POSSIBLY DUE TO DIET unknown onset, LOSS OF APPETITE, INCREASE IN INFLAMMATION POSSIBLY DUE TO DIET unknown onset and HEADACHES with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment information was provided.
On 10/12, patient had chest pain described as tightness that radiated to teeth.   He became nauseated and diaphoretic.  He presented to the ER.  Patient treated with nitroglycerin sublingual, acetaminophen, aspirin and diphenhydramine.  Patient has cardiac catherization and is admitted to the hospital post procedure.  Patient is to follow up with cardiology as outpatient.
The patient (age and sex unknown) received Tice BCG (indication and therapy dates unknown), and has subsequently experienced joint pain and nausea for approximately 1 week.  The patient is afebrile.
Swollen arm with redness, POTS (fatigue,, dizziness, lightheadedness, blurry vision, increased heart rate upon standing, shortness of breath, exercise intolerance, nausea)
This case was reported by a pharmacist and described the occurrence of (r) leg numbness in a 19-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 May 2012 the subject received 1st dose of HAVRIX (1 ml, unknown route, left arm) On 9 May 2012, 1 hour after vaccination with HAVRIX, the subject experienced (r) leg numbness. The right leg numbness "lasted a couple of hours and resolved." Per the pharmacist, the subject did not seek medical attention and returned to receive her second shot. At the time of reporting, it was unknown if the subject received the second shot. On 9 May 2013, the event was resolved.
pain in the left arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an (age:74, unit: unknown) unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from Nov2020, there was blood clot on her right lung. The patient concomitant medications were not reported. The patient experienced pain in the left arm that lasted for 10-15 minutes after getting the 2nd dose. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 1 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA intense dizziness and vertigo beginning day after vaccine administration, noticed when woke up around 11:30am. Intensity continued through the following day and began to subside ~55 hours after vaccine. Mild dizziness remained on day 3, and an OTC antihistimine was recommended to assist. No remaining dizziness on day 4
patient developed itching throughout her body approximately 25 minutes after administration. She was observed for 15 minutes. No hives developed.  This itching came and went
shingles; Informnation has been received from a lawyer refers to a patient of unknown age and gender concerning a case in litigation. The patient's concurrent conditions, historical conditiona and concomitant therapy were not reported. In or around November 2011, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient 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 company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was unknown.  The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Warm to touch, red circle at injection site 3" in diameter, tolerable, but sore.
I have a history of POTS: low blood pressure and elevated heart rate, which includes dizziness, lightheadedness, and nausea. HOWEVER, my POTS symptoms had improved substantially, almost seeming to disappear, after doing a lyme disease treatment BEFORE I got the vaccine. Right after getting the vaccine, I developed what seemed to be a normal reaction to the second dose of the Pfizer vaccine that others experienced. But my POTS symptoms are now INCREDIBLY worse than they were before the second dose of the Pfizer vaccine.  Since getting the vaccine I have had to start taking MIDODRINE, 10MG, 3X/DAY. While I had bad POTS symptoms YEARS AGO, I do not recall ever needing to take this much medication for such a long period of time because I felt so faint.