chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat; Came down with COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Dec2022, outcome "unknown", described as "COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat"; COVID-19 (medically significant) with onset 05Dec2022, outcome "unknown", described as "Came down with COVID (I tested positive on 05Dec2022)/trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) positive, notes: I came down with COVID at the beginning of December (I tested positive on 05Dec2022).  Clinical course: Patient received 5 Pfizer COVID-19 vaccines and/or boosters (including a bivalent shot on 17Sep2022.) Unfortunately, I came down with COVID at the beginning of December (I tested positive on 05Dec2022). My symptoms lasted long and were not sever but definitely not mild. I had trouble breathing, muscular pain, head ache, cough (with pain in lungs), mucous, fever, lethargy, brain fog, sore throat. I wanted to reach out since it was my understanding I had "protection" for 3-4 months and to provide feedback.  The lot number for [BNT162b2, BNT162b2 omi ba.4-5, BNT162b2], was not provided and will be requested during follow up.
Swelling noted on his body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling noted on his body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling noted on his body). At the time of the report, SWELLING (Swelling noted on his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported  Treatment information was not provided
pATIENT FAINTED OR FELL OUT OF CHAIR WHILE WAITING THE 15 MINUTES
This is a spontaneous report from a consumer (medical assistant), from a contactable other HCP (healthcare professional), from a contactable physician and from a contactable consumer reporting for herself. A 74-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot number J20347, Expiration date Jun2016, NDC number 0005197101) on 02Apr2015 at 0.5 ml single in the right deltoid. Relevant medical history included high blood pressure, hyperlipidemia, mild diabetes, and vitamin D deficiency. The patient received in the past an unspecified pneumococcal vaccine. Concomitant medications included ongoing potassium, ongoing metformin, ongoing losartan, ongoing Aspirin, CRESTOR, ongoing hydrochlorothiazide, and ongoing Vitamin D. On an unspecified date in 2015, the patient had an allergic reaction due to PREVNAR 13 injection. The patient stated that the event was in the arm where the vaccine was administered. The medical assistant mentioned that patient did not receive any treatment in response to the event and no laboratory tests were performed. Also the patient developed side effects from the vaccination, such as numbness, tingling and discomfort on unknown date in 2015. Additionally, the patient added that she was having so much pain and her arm was practically paralyzed on unknown date in 2015. Treatment of pain included unspecified pills. All the events were not recovered and she is having so much pain in 2 fingers at night. According to the consumer she was hospitalized for the events allergic reaction in arm where the vaccine was administered, numbness, having so much pain, discomfort and tingling. The other HCP, on behalf of the physician, reported that the patient did not require hospitalization in response to the event, and also considered that the vaccine had a causal effect to the adverse event. Follow-up (13Jul2015): New information received other HCP on behalf of a physician: includes: clinical course, reporter's comment on causality assessment. Follow-up (09Sep2015): New information obtained from a contactable physician includes: additional events (numbness, tingling and discomfort). Follow-up attempts completed. No further information expected. Follow up (14Oct2015): New information received from a contactable consumer reporting for herself includes: additional events (having so much pain and her arm was practically paralyzed), treatment, past vaccine history and outcome. Follow up (02Nov2015): New information received from a contactable consumer reporting for herself includes: details on concomitant medications, outcome and seriousness criteria for the events. Follow-up attempts completed. No further information expected.
Reaction: patient developed erythema, swelling and pain in left arm after injection of influenza and pneumococcal-23 vaccines. Other symptoms include patient reported fever of 102F, and scratchy throat. Management: the patient took diphenhydramine at home with no relief and acetaminophen for fever. The day following vaccination, patient reported to clinic for evaluation. Plan per clinic note to use ice, elevation, and diphenhydramine to treat local reaction. Patient instructed to present to emergency room if symptoms worsen.
Received FLUZONE HD on 10/13/15. (1st time receiving high dose flu shot) went to ER by ambulance on the night of 10/13/15. Had a fever of 104 degrees F and increased heart rate/chest pains. Was treated for symptoms and discharged home. Previous years received regular trivalent flu shot.
booster; Breakthrough COVID infection and symptoms following vaccination series and booster with Comirnaty; Breakthrough COVID infection and symptoms following vaccination series and booster with Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose Number:Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Breakthrough COVID infection and symptoms following vaccination series and booster with Comirnaty". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
PATIENT RECEIVED PFIZER COVID-19 VACCINE ON 05/20/2021 AND THREE DAYS LATER ON 05/23/2021 PT STARTED NOTICING SWOLLEN LYMPH NODES ALONG THE COLLOR BONE AREA. HE CONTINUED TO MONITOR FOR SEVERAL DAYS AND FOLLOWED UP WITH PT ON 06/02/2021 WHO STATED THAT THE SWELLING WAS STILL APPARENT AND HE MADE AN APPOINTMENT TO SEE THE DOCTOR TO FOLLOW UP WITH THIS ADVERSE EVENT.
Severe allergic reaction with hives that started on my face and moved down to my neck and body also with a cough. Went to Er bc my face felt like it was on fire and they gave me meds and a steroid shot and I know have to take steroids for 3 days along with Benadryl every 6 hours as well.
Within three hours of administration, patient noted swelling in pain in injection arm. Patient went to the ER for evaluation and was then hospitalized for four days. Fluid was surgically removed from injection shoulder and was treated with antibiotics, but cultures and MRI were negative.
Patient currently admitted fo inpatient stay at (2) days.   H & P:  Patient is a 65 y.o. female with history of DVT in 9/2021, HTN, hashimotos who presented with COVID and shortness of breath with hypoxia. Patient has neurocognitive deficits/dementia and is a very poor historian. Lives with her daughter but daughter is UNvaccinated and was unable to come back to provide history. ED called daughter several times with no call back and other daughter was called but patient does not live with her and there appears to be some sort of odd family dynamics so also unhelpful. Apparently per daughter who spoke with nurse at triage prior to leaving, patient tested positive 12/1 and on Saturday unintentionally took 20-22 tabs of tylenol (unconfirmed). Symptoms have included cough, weakness, shortness of breath and diarrhea. She was hypoxic at home in the mid 80s which prompted daughter to bring her in. She was very weak in the ED and hypoxic to 88 on room air sitting at the edge of the bed. She was admitted for further management. Decadron given.    Patient says she thinks she started having symptoms last week. Initially doesn't recall getting vaccinated against covid, doesn't understand many questions. Says she doesn't know if she's been taking eliquis. Doesn't knwo when she started or when she stopped. Doesn't recall taking so much tylenol. Very poor historian.    ED labs revealed hyponatremia at 127 patient appeared dry received 1 L IVF.  Assessment and plan:Acute respiratory failure with hypoxia COVID-19 pneumonia -supplemental O2 as needed -positive 12/1/21 -vaccinated July/august 2021, no booster yet -currently on 2L O2 -daughter with whom she lives is not vaccinated, did not come back with her and unable to be reached via telephone. Will hold off on remdesivir until she can be reached. -continue decadron x 10 days   Hyponatremia -likely hypovolemic + HCTZ use -repeat BMP at midnight -s/p 1L in ED. Cautious fluid resuscitation given COVID.    Unintentional tylenol overdose -apparently per daughter took 22 tabs of tylenol (unclear exact amount)  -LFTs normal -tylenol level <5 -monitor CMP daily -avoid acetaminophen   DVT 9/2021 -was on eliquis. Per patietn she doesn't recall when she started or stopped it.  -await pharmacy review of meds and if not on it any longer, will start lovenox. If still taking it will continue.    HTN -hold HCTZ -continue lisinopril   Dementia/neurocognitive deficits -sees neuropsych outpatient -unclear if she has DPOA paperwork, but will likely need it.   Hashimotos -continue synthroid   Diet: general DVT ppx: Lovenox Code Status: FULL CODE BY DEFAULT GIVEN DEMENTIA AND INABILITY TO REACH DAUGHTER  Dispo: Admit to IM
vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.   Treatment information not reported.
This spontaneous report was received from a consumer (patient's mother) and refers to a 13 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. It was reported that the patient was accidentally given four doses of GARDASIL, intramuscularly, on 10-JUL-2008, 12-SEP-2008, 04-JAN-2009 and 24-JAN-2011. Exact dose, lot numbers and expiration dates were not provided for these vaccinations. The consumer reported that, on an unspecified date, her daughter experienced "adverse reactions starting with the first shot" (not specified which of them occurred after the first vaccination). The patient experienced fatigue, vomiting, nausea, migraines, chronic pain, and on an unknown date, she was diagnosed with dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The patient was hospitalized in two hospitals (dates unspecified) and she was treated with unspecified pain medications. it was also reported, that the patient visited homeopathic doctor for detoxification (details unspecified). Laboratory diagnostic studies were performed: blood work, spinal tap, cat scan, magnetic resonance imaging (MRI) and numerous scopes (dates and detail were unspecified). The patient did not recover from dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Spread of vaccinia from original site; autoinoculation site of spread = a few inches inferior to original inoculation site.
Minor rash (small bumps) on both lower arms between elbows and wrists; minor rash (small bumps) near belly-button; MAJOR whelps and blisters covering anterior and posterior legs areas between knees and ankles, and posterior left leg between gastrocnemius and glutes on left leg.  Application of Maximum Strength Benadryl cream multiple times daily for past 2 weeks, application of oatmeal lotion daily, oatmeal body wash in warm shower daily, and 50 mg of Benadryl capsules 4x daily (total of ~200 mg daily) for past 2 weeks.  Condition is almost clear with only a few blisters and whelps remaining.
Circular , red , swelling, 1 inch in diameter  about 4 inches below administration site. Limited movement in arm, pain reported.
In the weeks following the second Covid shot, I became painfully stiff in the low back and upper legs. Also, balance was badly affected.
Still has great deal of redness in her arm; Redness at the injection site; Swollen at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Still has great deal of redness in her arm), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Swollen at injection site) and INJECTION SITE PAIN (Soreness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM for Anxiety, LEVOTHYROXINE for Thyroid disorder NOS.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ERYTHEMA (Still has great deal of redness in her arm), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Swollen at injection site) and INJECTION SITE PAIN (Soreness at injection site). At the time of the report, ERYTHEMA (Still has great deal of redness in her arm) had not resolved and INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Swollen at injection site) and INJECTION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Lump developed in thigh at injection site about the size of a pea or maybe a little bigger. It itches and sometimes it flares up and is worse than at other times. My daughter scratches it until it bleeds and sometimes it wakes her up at night. She started getting the lump pretty much right after she was injected and she still has the lump now, over a year later. She has two bumps with the same symptoms in her other two injection sites on both hips. I'll report those two separately. Her doctor has been notified several times and advised us to report the adverse reaction. Dr stated could possibly be ARTHUS reaction.
22DEC97 in evening devel nausea & extreme thirst-no r/t inc salt intake;7AM on 23DEC97 awoke w/lt eye swollen shut, puffy eyelid & under eye;eye itchy & red from rubbing;seen by MD claritin prescribed & is taking as of noon 24DEC97;
The injection site area was immediately swollen and stiff within hours of receiving the vaccine. That went away, but about 4-5 days after the vaccine, upper left arm became extremely hot, itchy, red, and swollen for about one week. Still is itchy despite swelling and redness going away. Also was very tired roughly in hours 36-48 hours after dose 1.
Nausea; Headache; This case was reported by a consumer and described the occurrence of nausea in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2021, 1 days after receiving Shingrix, the patient experienced nausea and headache. On 30th June 2021, the outcome of the nausea and headache were recovered/resolved.   It was unknown if the reporter considered the nausea and headache to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The patient received 1st dose of Shingrix and on next day experienced nausea and headache for 1 day. Patient declined to provide health care professional information. The reporter did not consent to follow up.
lethargic; unable to get out of bed; This is a spontaneous report from a contactable nurse. A patient in late 50's or 60's of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. It was reported one of the report's doctors in late 50's or 60's was lethargic and was unable to get out of bed for 2 days on an unspecified date after getting the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.
Patient came in with severe abdominal pain and resulted positive for COVID. Patient is fully vaccinated with the booster.
Information has been received from a registered nurse concerning a 15 year old female with no known medical history or allergies who on 15 Sep 2006 was vaccinated SC with a 0.65 ml dose of Varicella Zoster virus vaccine live (lot #652965/0622F) instead of varicella virus vaccine live. Concomitant therapy included Diphtheria toxoid/tetanus toxoid. The nurse reported that this was not product confusion. As of 18 Sep 2006, there was no adverse reaction noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional information has been received from the registered nurse who indicated that this was an error made by the administering medical assistant. The nurse reported that she was unable to remember any additional information about the incident. She also indicated that additional education about the vaccines was performed. No further information is expected.
Narrative: SORENESS AND FATIGUE LASTED 24 HR  Other Relevant Hx: Symptoms:  & FATIGUE AND SORENESS AT INJECTION SITE Treatment:
Desturations, mottled skin, bradycardia, irritability. All this occurred about 8-9 hours after Pediarix/HIB/Prevnar administration. Child had to be placed on O2, CR monitor and pulse oximetry for 2 days. Vaccine given while in hospital (prematurity).
Swelling, pain, faint erythema from injection site to elbow. Allergic to PCN causes throat and facial swelling. Prescribed ____, diagnosis early cellulitis vs immunization reaction.
Case number PHEH2013US013444 is an initial spontaneous report received from a nurse on 19 Jun 2013 with a follow-up received on 09 Jul 2013. This report refers to an 11-year-old female patient. Her past medical history and concomitant medication were not reported. She received only Men A lyophilized component of MENVEO (batch number: M12024, expired date: Dec 2014) reconstituted with a sterile diluent (not with Men CYW-135) intramuscularly on 17 Jun 2013. No adverse event was reported following medication error. The nurse reported that she would be re-vaccinated with the correctly reconstituted MENVEO. Follow-up received from the nurse on 09 Jul 2013: Updated patient demographics and information on re-vaccination.
High temperature (range from 102 to 104 Deg) entire body for up to 2 weeks. Used ice bath to lower temp to 97 deg (normal for me). Currently (03?Aug/22) I have headache, bodyache, handache, extreme exhaustion, frequest sleeping beyond normal 8 hrs., unable to smell, foggy/dizzy with memory loss, difficulty with taking exams (including cognitive test from neurologist who did not want to hear about my C-19 issue with regards to cognitive challenges therefore I reported the Doctor to insurance Quality Dept for not providing my legal right for medical treatment. Doctor fired me due to no explanation provided), and outbursts of crying and feeling hopeless. Recent blood results show below RBC levles and immune cells are low and out of test range (date of test 21Jul22). I never had a medical history of low cell numbers. Promary doctor communicated that it will take 3 months for cells to rejuvinate & I should feel better (Dr, appt on 01Aug2022 and documented in medical chart.Note: I have never had a reaction to any vaccine in my lifetime until the C-19 booster (other C-19 vaccines was okay)
Patient received vaccine 3/1 and stared having reaction described as redness, bullseye-appearing mark 1-2 inches below the injection site. Low grade fever 99F on 3/3, slight body weakness. On 3/4 awoke with 104.4F fever, worsening malaise, stomach upset, HR > 125, bordering need for ED visit.  On 3/5 started to feel better, gain energy back and reported to pharmacy on 3/6.
Date of Admission: 10/13/2022   Date of Discharge: 10/15/2022   Admission Diagnosis: Hyponatremia     Hospital Principal Problem (Discharge Diagnoses): Syncope
developed a headache about 15 hours after receiving / vaccine / has not resolved yet but is fading some; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2021, the patient received the 2nd dose of Shingrix (intramuscular). In June 2021, 15 hrs after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient developed a headache about 15 hours after receiving her second Shingrix vaccine.  The headache has not resolved yet but was fading some. The reporter did not consented to follow up.