chrisvoncsefalvay/vaers-outcomes huggingface dataset:
enlarged breasts; red area below injection site; raised area below injection site; pain below injection site; This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax. Concomitant products included cortisone (non-proprietary) (Cortizone Injection).   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, 1 day after receiving Shingrix, the patient experienced pain localized, breast enlargement, localized erythema and swelling. On an unknown date, the outcome of the pain localized, localized erythema and swelling were recovered/resolved and the outcome of the breast enlargement was not recovered/not resolved.   It was unknown if the reporter considered the pain localized, breast enlargement, localized erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm 24 to 36 hours after vaccination with Shingrix, the patient developed a painful, red, raised area on her left bicep, several inches below the injection site, this reaction lasted 3 weeks and had resolved. The patient also developed breast enlargement 3 to 4 days after her first dose, and this had not resolved at this time of reporting. The reporter did not have all the details of this case. The patient consented to follow up.
Went to the hospital, a couple weeks after 2nd dose with  severe chest pain, I felt like I was having a heart attack. After the hospital visit I had a follow up apppointment on August 23rd with my primary care physician due to on going chest pain. My primary care physician sent me to a specialist for heart monitoring and an echo. I was seen by Cardiologist October 13th who put me on a heart monitor and ordered an Echo. While at this appointment I explained this chest pain began after my second dose of the covid-19 vaccine.  I have never had chest pain before the vaccine. He explained that he believes I could have Pericarditis possibly due to the vaccine but wasn't sure. I haven't had my echo yet because it's scheduled for November but I am currently wearing a heart monitor right now.
Chest pains, Occasional stabbing chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains, Occasional stabbing chest) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021 at 8:00 AM, the patient experienced CHEST PAIN (Chest pains, Occasional stabbing chest). At the time of the report, CHEST PAIN (Chest pains, Occasional stabbing chest) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Elevated 90-130 bpm..         Since June 2021, Patient experienced sharp stabbing chest pain in the left side upper chest which radiated through left shoulder and down left arm. when this happened, heart rate was elevated from  90-130 bpm..  Patient experienced at very random times and was not a constant issue, when it happened it lasts for 20 mins to hours.  Concomitant medications were not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant information included Reporter details ,Patient demographics, Suspect Product details  and Event information and narrative was updated accordingly.
the administration of Infanrix to a 22 y/o patient instead of Boostrix; the administration of Infanrix to a 22 y/o patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 22-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 27-SEP-2023, the patient received Infanrix. On 27-SEP-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: the administration of Infanrix to a 22 y/o patient instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: the administration of Infanrix to a 22 y/o patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Oct-2023 The case was reported by medical assistant. The reporter did not consent to follow-up. The patient received a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Patient developed large lump near left clavicle a couple of days after vaccination. Patient scheduled an E-visit and primary care visit. Primary care provider originally referred patient to Dermatology for large lump (cyst) removal, then recommended patient receive ultrasound of the large lump. Ultrasound showed several enlarged lymph nodes. Team determined that patient did not need further treatment unless the large lump became worse. Large lump has since resolved.
Received DTaP, next day cried all day, then symptoms of laryngitis, cough. Fever for 1 day with a few days of vaccine. URI sx's persisted for weeks.  Seen in E.D. 10-23. Diagnosed with URI (see record) Ongoing symptoms then seen 11-11-19 diagnosed with otitis media & pneumonia, Rx Augmentin (no chest x-ray done)  Seen by me 11-15-19: Diffuse wheeze, diagnosis bronchiolitis
pt had uncontrolled screaming for 3hr following vax;parent stated scream was different than any they prev heard from pt;also swelling of rt leg;pt became pale
Swelling tenderness at site with redness that expanded from lemon sized to 10cm by 12cm on left upper arm. Awoke to day with some transient dizziness and hard time taking deep breath that lasted for a few minutes then resolved. She denies fever chills shortness of breath cough or chest pains or palpitations. Taken Benadryl beginning 4/17/2012 and once this morning befor visit. Repoted helpful with itching and swelling at site but site enlarged despite intervention and cool compressed.
bad headache; arm got so sore she cannot hardly move it  from shoulder to elbow; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYALGIA (arm got so sore she cannot hardly move it  from shoulder to elbow) and HEADACHE (bad headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Peripheral arterial disease.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (arm got so sore she cannot hardly move it  from shoulder to elbow). On an unknown date, the patient experienced HEADACHE (bad headache). At the time of the report, MYALGIA (arm got so sore she cannot hardly move it  from shoulder to elbow) had not resolved and HEADACHE (bad headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include two types of blood thinners used for unknown indication. Patient was told to apply heat and rub pain relievers, but they did not help.
PT began having T101, chills and difficulty sleeping, called PMD 10/04/07 at 3pm and inst to take Motrin, fever broke at 430p. By 1130p T103.7, went to ER given fluids and Levoquin, blood work. 10/06/07 at 1200n, T98.8, R arm remains red, painful to touch to elbow
Vomiting lasting 48 hours, Diarrhea lasting 7 days, muscle aches, fever lasting 7 days, lethargic 4 days
Arrived via EMS on 2/14 unresponsive. Intubated on arrival secondary to acute hypoxic respiratory failure. Concerns for GIB due to black tarry stools. CXR representative of interstitial edema versus infection. CT chest chest significant for pneumonia or aspiration, severe emphysema cardiomegaly. COVID +. Given IVF, nexium, vanocomycin, cefepime, and 1 unit PRBCs in the ED. HR in the 180s and cardiology consulted and started amiodarone and heparin drip. No further signs of active GI bleed with H/H stable. Acidodic and given bicarb. Continued to decline and vasopressors x 2 along with increased ventilatory support. Started on flolan. Sedation was turned off and reamined unresponsive to pain. Family decided to abide by his wishes not to be on life support with comfort measures only.
Hives on hands, chest; Face redness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 10:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The patient had a history of allergy to penicillin and azithromycin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not receiving concomitant medications. The patient did not receive any other vaccine with four weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced hives on hands, chest and face redness (for now 10 days). It was unknown if therapeutic measures were taken for the adverse events. The clinical outcome of the events hives on hands, chest and face redness was not recovered.   No follow-up attempts are needed. No further information is expected.
After about 15 minutes my left hand was completely numb after I went to bed and wake up my left side was numb and very painful I had sores under my nose and the left side of my face was swollen this lasted for four days pain was on and off.
Shot given on left deltoid. Redness, inflammation, soreness appeared about 2 inches below shot location 2 days later. Counseled patient to continue to monitor site and to apply hydrocortisone cream and/or benadryl cream to reduce inflammation.
Pt presented 03-30-2021 for pre-dental COVID-19 testing.  PCR testing was positive.  Currently asymptomatic.  Known positive PCR 12/4/20, 12/16/20, 12/30/20, 1/13/21.  PCR and antigen negative 1/27/21.  IgG positive 12/16.  Has received both doses of Pfizer Covid 19 vaccine: Prime dose:  12-30-2020  Booster Dose: 01-20-2021.
patient was given 2nd dose of Fluzone vaccine too early, No AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who was vaccinated with second dose of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] too early. The lot number and expiry date not reported.  Medical history and concomitant medication was not reported.   It was a case of actual medication error due to Inappropriate schedule of vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Diagnosed with Trigeminal neuralgia of right side of face;  Symptom onset 3 days after1st COVID vaccination.   pain, tingling, burning on one side of face,  no numbness or facial droop; 1 week of symptoms so far.  Symptoms include:  Patient had second Pfizer dose on November 10. On November 13, he developed a tingling sensation and sometimes a burning sensation on the right side of his face and in his nose. This can get to a 4/10. There is no numbness, and no weakness or loss of control. No sores, no rashes, no blistering. Unable to schedule within disposition, please advise. Notes from PCP visit 11.23.21:  Patient is a 32 y.o. male who presents with facial tingling/pain: Noticed onset 10 days ago 2/2 covid vaccine given 10/10 - 3 days later - unsure if related No sx in 48hrs after vaccine Feels great otherwise today - ran 7 miles this AM;  No headaches Tingling, burning under R side lip;  then upper lip;  Then R cheek and under R eye No other sx - no drooping, slurring words; Been monitoring closely and has not seen a rash  Severity down a little since onset - currently 4-5/10 - annoying New pain in trigeminal distribution Discussed diagnosis No red flag symptoms but discussed differential Could consider labs, MRI/MRA brain Will hold on work up today and monitor which is reasonable If any worsening or not resolving over the next week consider starting with labs ( CBC, cmp, vit D, b12, TSH)
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 21-OCT-2015, and then on 16-DEC-2015, the patient was vaccinated with RECOMBIVAX HB (dose and route and lot number were not provided). Concomitant medication was not reported. No adverse symptoms were reported and there was not product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in 2016 (reported as starting on or after 11-FEB-2016), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030868, expiration date 09-JUN-2018, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 46.8F for 2 hours. No previous temperature excursion was reported. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
I got the vaccine at 5:00 PM 11/12/21. I woke on 11/13/21 with  body aches and fatigue. at around 2:30 PM on 11/13/21 I developed a low-grade frontal headache and low-grade fever of 99.7 F. This persisted through the evening. At 8:00 I still had it. I went into the kitchen to get some soup, and while standing at the counter suddenly felt lightheaded and nauseated. I yelled NO NO NO and started to go down. The next thing I knew my poor husband was standing over me and I thought I was in bed! He told me that I had fallen and twisted my leg really badly. I told him I needed to go to the bathroom. I made it there then proceeded to have diarrhea and vomiting. I was also sweating profusely. After that I rested and those symptoms resolved, BUT I sustained a pretty substantial sprain strain to my left medial collateral ligament, my entire right knee, and my right foot and lateral ankle. It hasn't prevented me from working (I'm a physician) but it has prevented me from riding my bike, my chosen and favorite form of exercise! So, I had an episode of vasovagal syncope.  I think it's noteworthy that a little before the event I took about 35 mg of CBD. CBD can cause a sudden drop in blood pressure which can lead to syncope, nausea and vomiting
Lichen planus/ autoimmune skin disease; she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (Lichen planus/ autoimmune skin disease) and RASH (she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse). On an unknown date, the patient experienced LICHEN PLANUS (Lichen planus/ autoimmune skin disease). At the time of the report, LICHEN PLANUS (Lichen planus/ autoimmune skin disease) and RASH (she started having 1 or 2 rashes/then started having this rash all over her body/Then it kept getting worse and worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) She went to the dermatologist, did a biopsy, and the diagnose was lichen planus, like autoimmune skin disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. As treatment, patient received cream with steroids to apply. Patient reported that there is no treatment for the disease and she received something only to treat symptoms.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/4/2023,  1/5/2023,  1/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt is known to have COPD; had excerbation needing hospitalization from 28OCT91 to 5NOV91;
11-16-09-Post immunization running nose, chills, hives, HA, etc. 11-17-09- Running nose & hives & broncho-spasms, etc.11-16-09-present-Chronic hives(possibly egg-related).
30 minutes after I woke up on 1/13/2022, the day after the vaccination, I started experiencing severe vertigo. I could not stand or walk by myself. I could I sit upright. These symptoms lasted for 24 hours. I woke up on 1/14/2022 and the vertigo was gone. For the first couple of days after this incident I was exhausted and feeling very out of it. I thought this would pass given what just happened.  Feb I went to the Dr. because my heart was racing and I felt off. I also developed my first UTI. I am still experiencing several of the symptoms described above 4 months later.
testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 14 patients. This is the 9th of 14 reports.  An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. It is reported patient testing positive for COVID after receiving vaccine. 8 Patients and 6 workers at a long-term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they are testing positive, physician wants to administer bamlanivimab (drug being administered under FDA EUA). Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021063794 Same reporter/product/event, different patient
I received my second Pfizer booster on 4/25/2022. On about 5/14/2022, I saw what appeared to be a swollen, infected area on the knuckle corresponding to my left index finger. Over the course of a week, it increased in size, causing tenderness and pain to the touch and pressure. On about 5/17/2022 or 5/18/2022, I pierced it with a clean needle to relieve the pressure. It emitted a combination of what appeared to be pus and lymphatic fluid. There was no blood, however. Over the course of the following week, the initial bump on the knuckle lessened in size, but it remained an open, weeping wound. I then noticed swelling in between that region and the base of my left thumb. Following that, various other hard swollen subdermal bumps appeared on my left arm. The largest is on top of my left wrist. There are several smaller bumps on the inside of the bend of my left arm, plus another subdermal bump on my left forearm. On the inside of my left upper arm, there appears to be a red streak. Underneath part of the streak there is a subdermal bump. This has persisted to the time of this writing. On 6/3/2022, I went to the doctor. The doctor was unsure about the cause of the bumps, but he guessed that they were symptomatic of a bacteriological infection. On that same day, I began a regimen of amoxicillin. Thus far, I have seen no change in my condition, so I cannot say whether or not the treatment has been effective. I returned to the doctor's office on 6/6/2022. I saw a different doctor, who gave the same diagnosis as the previous one. I was further prescribed a clinically administered injection of Rocephin. I was prescribed additional oral antibiotics. One is doxycycline monohydrate (100 mgs. twice a day) and the other is cephalexin (500mgs three times a day). As of the time of this report, I cannot tell if these have had any effect.
pt recv vax & devel an inj site rxn characterized by erythema & induration;addtl info was recv on 19AUG96;pt was also treated w/Westcort cream & recovered;
Immediately following the shot I became lightheaded and stayed longer than the mandatory 15 minutes. Later that evening My are was sore and I continued to be dizzy. By nighttime I felt achy and tired. About 6 hours after the shot a fever started and I took Tylenol. By 1am I had 101.3, the rigors and a headache and dizziness which I still have 4 days later. My fever ran for over 48 hours and would not respond to any  ibuprofen or Tylenol. My joint and muscle pain was severe, my balance was off. I could barely move my arm. Today I am now nauseous. I was not this sick when I had Covid. My fever would at least relent. I?ve lost time from work and my life. I have heart palpitations and my resting heart rate has gone up. Pressure feels strange behind my eyes. My legs are sore.   I called my doctor two days after my vaccine and she minimized my symptoms.
I got the shot and started to feel light headed, they put  me in a little area and took my BP its 192/110. I had a little grab in my chest. I was there for 15 mins. They called the EMT and took me across the street to the ER. They did blood test and EKG and my BP was still high when I got there. The EKG and BP. x-ray of my heart was ok. They had to keep me there 4 hours to re-do test to make sure I didn't have a heart attack. MY BP was coming down but still high when they sent me home.  I sent an email to my PCP and she said there is a lot of side effects with the vaccine. After two days I was fine.
pt recv vax & 2wk later pt had an asthma attack & fever; The reporting MD doesn't feel there is a causal relationship; No further details were provided;