chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen face; neck lymph nodes; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 11:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any other medications in two weeks. The patient previously received morphine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 12Apr2021, the patient experienced swollen face, neck lymph nodes and headache. The events resulted in emergency room/department or urgent care. It was unknown whether therapeutic measures were 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 event swollen face, neck lymphnodes and headache were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning an approximately 31 year old male patient who was vaccinated with a dose of MMRII as a child. On 09/28/01, a premarital titer result were equivocal for mumps. The physician also reported that the patient's girlfriend also experienced lack of response after vaccination with MMR (see WAES01100626). Additional information has been requested.
Patient presented to the office on 3/31 with increased respiratory rate and was found to have an elevated blood sugar of 450.  He was diagnosed with diabetic keto acidosis and admitted to the intensive care unit.
BUD date was not reviewed prior to administration of vaccine. Lack of attention to detail on date written on vaccine box. Nurse contacted Pfizer and validated that vaccine is still viable up to 2 days past the BUD date.  Manager contacted patient?s mother to explain incident reviewed details.
Next day for 3 days very bad body pain; Day 4-5 extreme fatigue; Day 4-5 extreme vertigo.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 05May2021 at 17:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's, sjogrens and allergic to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and hydroxychloroquine sulfate (PLAQUENIL); both were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 17:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 10:00, next day for 3 days, the patient experienced very bad body pain. On an unknown date in May2021, day 4-5, the patient experienced extreme fatigue and vertigo. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events next day for 3 days very bad body pain and day 4-5 extreme fatigue and vertigo were unknown at the time of this report.    No follow-up attempts are needed. No further information is expected.
My son experienced four grand mal seizures three of which were in the hospital.  He was heavily medicated and prescribed dilantin for three months.  He was under the care of a neurologist until he was weaned off the medication.  He received early intervention services and special preschool services including speech, developmental, and occupational therapy both academic and clinical.  He is on the autism spectrum with PDD/NOS with continued learning problems and serious social problems.  He requires the help of a full-time aide to attend school. 5/2/08 and 6/24/08--records received-11/5/01-seen in neurologic clinic. Admitted 1 month prior after 4 seizures within 24 hours. DX: new onset of Seizures. Seizures described as jerking of extremities, eyes rolling up, unresponsiveness, last one for 15-20 minutes. No further seizures. Appears age approprieate. 1/20/2010 He is on the Autism/Aspergers/Sensory Integration Spectrum. He has not been able to make even one friend and he is almost 8 yrs old. He gets resource,  social work, speech, OT and 1:1 classroom aide support at school. He gets speech OT in a clinical setting. Developmentally delayed - PDD/NOS diagnosis-medical - Autism diagnosis- educational + sensory processing disorders. He can attend school, but only with 1:1 teachers aide in class and lunch and all special activities. He needs social therapy group, speech, OT, resource and social work weekly and somtimes daily.
ITP diagnosed 2/21/04. Medical record on 05/02/04 states: Viral infection. Follow up on 05/11/04: "Immune disorder."  As per annual follow up report 08/08/05 test still subnormal still unable to maintain normal levels for 6 months.
Case number PHEH2015US025834 is an initial spontaneous report received from a consumer (patient's husband) on 07 Dec 2015. This report refers to a female patient whose age was not reported. Past medical history included adverse reactions (unspecified) and her concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly on an unknown date. The patient had a mild allergic reaction to FLUCELVAX that was administered by her allergist and this was not the first time she had had an adverse reaction (unspecified). Her allergies stated that FLUCELVAX had the least amount of preservatives and other additives. The event outcome was unknown. The seriousness and causality were not reported.
One month later I began to have heart problems that led to stint put in vein.  a month after that I had chest pains and two more stints in the same vein.  I am still expierencing  mild angina in spite of being on medicine to reduce or eliminate the chest discomfort.
Arm became sore approximately 12 days after shot . On day 13, the area just below and in front of the injection site became swollen and hard and turned  a slight red color.  No treatment.
POTS, Dysautonomia, Syncope, Constipation, Arm/Shoulder/Joint Pain, Sinus Tachycardia
I received both vaccines while pregnant and had a miscarriage at 11 weeks (found out at my 13 week appointment). I had COVID in November 2020.
I received the Janssen vaccine on 3/19 at 8pm. 7 hours later ~3am I awoke to severe chills, climbing fever, and nausea. OTC fever reducers helped bring the fever down eventually. The entire day (3/20) my fever was on and off and nausea would also be present. Bouts  of feeling well and bouts of fever. Had a minor fever when going to sleep that day and the fever was gone when waking up on 3/21. So ~24 hours of side effects.
having chills/has chills all over; Freezing all over/cold; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK4176, NDC number and Expiry Date are unknown), via an unspecified route of administration, administered in Left arm (left shoulder) on 10Feb2021 at the age of 64-years-old as dose 1, single for covid-19 immunisation. Medical history included Coagulation disorder from an unknown date. Concomitant medication included warfarin (WARFARIN, Dosage text: 10 mg 4 days a week, and 15 mg on the 3 days a week) taken as blood thinner from 1994 and ongoing. There was no investigation assessment. The reporter, 64 years old, stated that she called in earlier to report that she was having chills on 11Feb2021. She received her 1st shot of the Pfizer Covid Vaccine the previous day and wanted to know if this side effect would last and for how long. She had the chills. She had her shot the previous day. The Pfizer COVID Vaccine, and today she was cold. She was freezing all over on 11Feb2021. The reporter asked was that supposed to happen, and how many days should it last? She declined email It is like she was just cold. She has chills all over. On the paper they give when giving the shot it does mention blood thinners. She was on Warfarin 10 mg 4 days a week, and 15 mg on the 3 days a week. She started it in 1994. The doctor told her to get it. The case was reported as non-serious. The outcome of events at the time of last observation was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Approximately 15 minutes after receiving injection, patient reported her nose and throat "felt funny".  Patient was directed to Emergency Department of parent facility.  Patient was examined by ED physician.  Symptoms did not progress.  No treatment was provided.  Patient was discharged home after 1 hour.
Jaw very painful and sore, swollen badly, can't eat, very painful, side of neck and throat swollen painful and hurts badly, fever, cold chills.
Right thigh at site of DPAT vaccine likely 2/12cm x 2/12cm hard induration, Cellulitis.  Treated with Rocephin.
I was hit with a body-wide feeling of extreme cold and chills, which lasted most of the day. I was back to normal the following day.
Symptoms included fatigue, nasal congestion, runny nose, dry cough, chills briefly, and felt like my body had trouble controlling my temperature. I felt like my skin was clammy and I had some sweats and felt hot throughout the night. That lasted for about 12-24 hours on the day I tested positive. The day after I tested positive, my symptoms dramatically improved beside the nasal congestion and runny nose. Towards the end of the evening, I started to feel a little sick again and having the fatigue come back a bit. This morning, I woke up feeling much better with the exception of slight nasal congestion. I did take some ibuprofen the evening I tested positive and yesterday as well. Symptoms wise, I've recovered 90% except for the nasal congestion. I have not yet taken another COVID-19 test to see if I've come back negative yet.
Patient was administered BioNtech Covid-19 vaccine>12 years formulation.  Should have received BioNtech Covid-19 vaccine 50-11 years.  Administration error disclosed to patients mother and  counseling was provided on what to expect in relation to increased side effects and systemic symptoms such as fatiques and fever noted with the higher doses.  Patient was monitored in the clinic for 25 minutes after administration.  No side effects noted during that time.
I started bleeding vaginally 2 days after the first dose but it was time for my period so I didn?t think anything more. After having a normal period I continued spotting for 3 weeks. Some more than others. I then got my second dose on 5/7/2021 ( lot EW0167 ) and starting bleeding again like a period and I now have been bleeding and/or spotting for over 4 weeks. ( still bleeding lightly as of today 5/16/2021 ). Not sure if it is related to the vaccine but this has never happened to me before.
pt recv vax; devel rash on extremities approx 10 days p/ 2nd dose of vax;no rash reported p/ 1st dose;
Nausea; Headache; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm right on 17Feb2021 at 15:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome(IBS), soy allergy and allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 18Feb2021 at 05:00, the patient experienced nausea, headache and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events nausea, headache and diarrhea was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt exp t102.0 rectal, inc warmth-rt thigh, screaming episode lasting 3hrs;
Patient called  the pharmacy and stated that  she isexperiencing side effects to moderm.  She states that her throat is painful when she swallows and that she has shoulder pain
Pericarditis, no myocardial involvement, no effusion, treated with NSAIDs and colchicine
Fever 101 degrees 7 hours after the vaccine. Shooting spark feelings down the left side of my body throughout the night along with chills and aches. Got up at 2:30 am to get water, passed out in the kitchen. Started vomiting. Two more episodes of loss of consciousness and continued vomiting until around noon that day.
Anaphylactic reaction; Tongue was swelling; Difficulty breathing; This is a spontaneous report from a contactable Pharmacist.   A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at SINGLE DOSE for COVID-19 immunization. The patient experienced "Tongue was swelling, Difficulty breathing, and an Anaphylactic reaction".No other details provided. The outcome of the events was unknown  Information on lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of Anaphylactic reactions presented as Tongue swelling/Difficulty breathing and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Got a lump under my armpit and it hurts and it's Inflamed and I feel like a burning sensation; It's just swollen; Fever; Chills; Body pain; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in right arm on 17Jul2021 at 11:15 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not taken any vaccination 4 weeks prior to COVID-19 Vaccine. On 20Jul2021, the patient experienced Got a lump under my armpit and it hurts, and it's Inflamed, and I feel like a burning sensation; It's just swollen, Fever, Chills, and Body pain. Patient already checked to see if there was like a bite or something or ingrowth but she didn't grow any like armpit hair. Therapeutic measures were taken as a result of fever, chills and body pain which included Advil tablet. Patients second dose was schedule on 07Aug2021. The outcome for all the events was unknown.  Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.
Patient came in for second dose of Moderna. She is 16 when we gave her the shot. Patient did not report an adverse  event from getting the vaccine.
Fatigue and myalgias set in about 6 hours after vaccine was administered  Shortly after, tachycardia set in with pulse at 140-150 bpm resting. Fever set in at 8 pm at 103F.  One OTC Benadryl brought pulse down to 130s resting.  Performed Valsalva Maneuver with pulse improvement  to 110s.  By morning, fever was still at 103F, with headache, muscle pain, chills, fatigue, pain at injection site,  and swollen lymph nodes present. Tachycardia had resolved.  Within 48 hours after vaccine was administered, all side effects had resolved except fatigue and swollen lymph nodes and headache.  All side effects had completely resolved 9 days after vaccine was administered.
Swollen lymph node under left armpit. Painful when moving arm and sensitive to the touch. Swelling lasted 4 days. No over the counter or prescription medications were taken for the symptoms.
Per mother, this patient had a fever, triggered asthma attack. The child missed several days of school.
PATIENT RECEIVED PFIZER 1ST DOSE 1/28/21, UNABLE TO GET 2ND PFIZER, GAVE OUR MODERNA FOR 2ND mRNa COVID VACCINE PER PATIENT,FACILITY, AND PHYSICIAN
Delayed hypersensitivity reaction 9 days later - swollen , red, itchy shoulder and down arm  at the sight of the injection with ipsilateral lymphadenopathy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: NSAIDs" (unspecified if ongoing), notes: Known allergies: NSAIDs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
4 days after receiving my shingles shot my wife developed shingles. She had the shingles shot herself Jan. 26, 2009 and we believe this shot gave my wife shingles.
I was informed on 2/24/22 at 9:46pm by patient's son who I work with via text that patient had a heart attack and patient left for the hospital on an ambulance. I was informed via text that patient died on 2/24/22 at 10:53pm. Patient's son came in to the pharmacy on 2/26/22 around 5pm and told me that they are looking in to if Moderna was related to patient's cause of death.
Seen in clinic 3-31-11. Left thigh was red, swollen and non tender to touch at vaccination site. Vaccine was administered 3-30-11. Redness and swelling began the following day.
I am really sick; I just feel really terrible; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I am really sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I just feel really terrible".  Additional information: It was reported that, patient got vaccine on Tuesday (unspecified date) and was really sick. Patient just want to make sure that was it okay to take like 'D quill' or anti-histamine (Unspecified medication), and was that safe to take cold medicines to comeback the symptoms or should patient just take Ibuprofen. Reported that patient just want to make sure and wanted to figure this out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 4/19/21 at about 9:00PM, I begin developing a migraine headache.  The headache worsen with time and became severe by 11:00PM.  After taking Inositol for sleep, I still had the headache the next morning, but it was less severe.  The headache had subsided by the end of the 2nd day. On 4/23/21 about 5:00PM, I notice that my upper lip was beginning to swell.  Within an 1 hour my upper lip was fully swollen.  Just a coincidence, I had just visit my doctor the same day earlier at around 8:15AM for a swollen knee area for which the doctor had prescribed 220mg Aleve for the swollen knee area and blood work.  The following day, my lip was still severely swollen, but the swelling began going down around 10AM.
Information has been received from a nurse, via a company representative, concerning a 20 year old female with a history of an abnormal papanicolaou smear, who on 19-MAR-2007 was vaccinated, iM in the buttocks, with the second dose of Gardasil. There was no concomitant medication. The nurse reported that on 19-MAR-2007, a few minutes after the vaccination, the patient "turned pale and fainted for a few seconds." The nurse reported the patient's blood sugar was 110 (units not specified). Subsequently, the patient recovered on the same day. additional information has been requested.
On about Feb 1 2022 I noticed that I was having unusual headaches, pounding headaches. These were unusual in their quality and intensity. When I checked my blood pressure was extraordinarily high - like 199/110 up to 201/178. My typical pressure is 134/85 when I am active. At rest it is maybe 120/78. Pressures were not returning to normal range for several days. After this continued I visited the doctor and was put on a monitor to check pressure. I began taking supplements. Calcium Lactate; Cataplex G; I saw the doctor several times. After 2 weeks of monitoring I began taking Metoprolol. With this my pressures were not where they needed to be and changed the meds to Lisinopril. This dose seems to keep my pressure under control.
She received the vaccine on 2/19/20, and then 2/20/20 had body aches, fever, nausea. She then developed a "lacy" rash  day on neck 2/21/20 that resolved by saturday 2/22. However, night of 2/22/20 and on 2/23/20 morning noticed an area of redness and warmth on her  L bicep that is not at the injection site. It  spread up the arm towards area of injection; used Hydrocrtisone cream to central part of rash and it helped reduce redness; used benadryl; used zyrtec which helped;
Pt c/o difficulty breathing, swollen eyes. Benadryl, solumedrol and epi auto inject given.