chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site became red, warm, raised, slightly itchy, slightly uncomfortable about 8 days after the shot.  In addition, I felt unusually fatigued on the 9th day, with noticeable arthritis pain in my thumbs (which I hadn't had for a year even though I've been playing the drums every day) - seemingly for no reason, and although I tried to do my usual exercise routine, I felt low energy and like my body just didn't feel well.  I slept okay and today the arm is the same but I feel better.  My thumb joints are much better, but not 100%
Terrible period starting the next morning --- out of my cycle.  Bright red blood to start.  Then nothing for a few hours. And then 7 days of the heaviest period I ever had including massive blood clots and heavy bleeding through pads and clothes.   The next month, in May, I had the worst cramps of my life again and a terrible period.  Now this month, I am five days late.
1.5 days later patient developed a localized red raised itchy area approximately 2 inches across.
Vaccine administered at 09:35am; At 9:45am, during a 30 minute observation, employee stated her throat was tight;  At 9:46am, employee self administered her own epinephrine pen into right thigh. Employee then taken to ER and checked in at 9:50am.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. On or about 11-JAN-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-MAR-2016 the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
1207 - Patient has involuntary movement of R leg (history of functional neurologic disorder). BP = 115/76, HR = 85 and O2 Sat = 98%.  1210 - Patient having bilateral foot movement. 1215 - No involuntary movement noted. 1220 - Patient sat on side of bed - no involuntary  movement noted, but has slight sense of aura. 1225 - Patient discharged to home with husband - ambulated without difficulty.  Advised to discuss with MD and to notify vaccinator of need to lie down for injection.  BP = 110/64, HR = 81, RR = 18 and O2 Sat = 98%
Swollen under arm/armpit, extremely tender to the touch and some movements restricted. started the day after shot and worsened as the day progressed. On second day after shot, lateral deltoid at actual injection site is also sore.  Underarm still swollen and painful.
Severe head ache, severe nausea with vomiting ever since vaccine has been given.
Mom reported that pt Had 3 separate episode where the child became confused and "not herself," was talking to fingers. Each episode only lasted "a couple of minutes." and then she returned back to her "normal self".  Mom reported that by 3/7/10 she was back to her normal self and did not have any more episodes. Mom also reported that patient's left thigh (DTaP site) became very red, swollen, and warm to touch. Swelling was gone by 3/10/10. Denied having a fever. Children's Motrin was given to patient by mom. Left thigh 3/12/10 with no signs of redness, swelling, skin pink warm.
H1N1 on 1-20-10 Felt fatigued, on 26 noted going up in elevator yielded loss of balance, severe increase in fatigue to slurred speech. Confusion increase in blood pressure to MD 2-2-10 condition worse to neurologist - small stroke med change admitted to hosp. 2-10-10 - Bradycardia (29).
8cm raised area warm, round red lesion, faded red area around red warm area with no heat, not raised.
Information has been received from a health professional concerning a 9 year old female patient with a history of yearly pneumonia who on 21-OCT-2006 was vaccinated IM into the right arm deltoid with "one time" 0.5 ml dose of Pneumovax 23 (lot # 650457/0973P).  Concomitant therapy included SYNTHROID.  On 21-OCT-2006 the patient experienced swelling of the right arm, pain and redness at site of injection.  The symptoms started within one hour of injection.  The patient also developed a fever up to 103.  The patient has been treated with alternating doses of ibuprofen and TYLENOL.  The symptoms had not yet resolved.  Additional information has been requested.
anaphylactoid rxn onset approx 20min p/vax;began w/a pruritus of scalp spread to back & UE's;diff breathing;returned to clinic BP 156/102, P140, R32;epi & DPH given;02 initiated;
Administered after vaccine Beyond Use Date, the Beyond Use Date was 01/13/2023 and immunization was given 01/16/2023. No adverse reaction reported.
Seriousness criteria other medically significant. Initial information received on 01 December 2006 from a health care professional. A 44 year old female patient, with no pre existing medical conditions and no illness at the time of vaccination, had received a left arm, intramuscular injection of Fluzone SV 2006/2007 lot number U2164AA, on 09 November 2006. Two days post vaccination, the patient experienced weakness in her left arm and hand. She reportedly now has numbness of the left arm and hand. She was examined in the office on 30 November 2006 and referred to neurologist. Diagnostic testing included a Lyme titer and ANA (results not provided). Follow up information received on 10 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received from 26 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received on 26 January 2007 from a health care professional. This case had been considered listed non serious for the information received on 01 December 2006 and 10 January 2007. Based upon new information received from this reporter, this case was upgraded to serious. EMG nerve conduction studies performed on 12 December 2006 were normal. A cervical and thoracic MRI performed on 08 January 2007 showed signal abnormality suggesting demyelination. Diagnosis from a neurology consultation was transverse myelitis. The patient is followed by neurology at this time. Additional information was not provided.  1/12/09 Received PCP medical records of 11/28/06-3/17/08. FINAL DX: transverse myelitis Records reveal patient experienced left arm/shoulder, breast & back symptoms of pain, numbness, burning, heaviness, low grade fever, fatigue, impaired touch sensation x 3 wks.  Received flu shot in RA.  Developed hyperesthesia/paresthesia of bilateral extremities, slurred speech & impaired mentation when fatigued.  Referred to neuro x 2.  Tx w/steroids & had some improvement.  2/16/09 Received Neuro consult medical records of 1/12/2007-3/2008. FINAL DX: transverse myelitis Records reveal patient experienced paresthesia of left arm & right leg, painful dyesthesia of left chest wall & feet, spasticity of left leg, fatigue, 18# wt loss.
Lymph node on the left clavicle became inflamed and enlarged sensitive to touch CAT scan and sonogram performed
no known PMHx who presented on 1/31/22 with stroke like symptoms - left sided weakness, poor gait. Pt was found to have an acute, large Right temporal lobe intracranial hemorrhage, confirmed per admission CT/CTA head and neck. His blood pressure was high 205/105 and his UDS was positive for amphetamine. NSG evaluated the patient - no surgery recommended. He was on mannitol for vasogenic edema, Keppra for seizure ppx. Repeat CT head was stable and now he is off keppra. He was sent to LTACH with trach collar: Covid positive Patient infected earlier last month on 1/8 No sx prior to current hospitalization  Patient is immunized  Off isolation per infection prevention
Patient is fully vaccinated. 34-year-old female with no significant past medical history who presents with complaints of body aches, chest pain, generalized abdominal pain, fever/chills, nausea/vomiting, headaches, dizziness, cough, and congestion that started about 3 days ago.  Patient states that her coworker tested positive for COVID and she was exposed to him on 4 days ago. BP 115/68  | Pulse 58  | Temp 98.4 °F (36.9 °C) (Oral)  | Resp 16  | Ht 157.5 cm (5' 2")  | Wt 68 kg (150 lb)  | SpO2 97% chest x ray: No acute intrathoracic process. EKG normal sinus rhythm. Started patient on a 1 L bolus of fluids and Toradol for pain.Gave her a dose of Norco. Discharged home.
Extreme fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient did not have any lot numbers for the vaccines, the date in which he got the vaccines, and he could not remember which arm he received the vaccines in. The patient stated that he got his Covid booster and first Shingrix vaccine on the same day on unknown arm at his local. The patient said that since getting these vaccines (Covid booster and Shingrix) a few months prior to the reporting date, patient had experienced extreme fatigue that had not resolved.   Spoke per content, gave medical disclaimer, and referred to health care professional for follow up. The reporter did not consent to follow up. No health care professional for follow up. It was unknown if the reporter considered the fatigue to be related to Covid booster.
This boy and his 2 brothers all received Varivax at different times and different lots.  All have been seen to confirm break through Varicella infection.
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information was reported. The patient age was reported as 67 Year 9 Month. Patients at the facility received vaccine between 08Apr2022 and 15Dec2022.  No treatment medication information was reported.
Patient is complaining of left shoulder and arm pain after the SHINGRIX, and has small cluster of blister above and below elbow on the upper and lower arm. Dr.ordered Acyclovir and TYLENOL #3 for patient.
Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.
Patient received Fluarix  Quad instead of Boostrix Tdap requested.  Administration of wrong vaccine. Correct one is subsequently given. on right lower arm. Fluarix was given on right upper arm
Insomnia leading to sleep anxiety (dose 2); Insomnia leading to sleep anxiety (dose 2); This is a spontaneous report from a contactable consumer, the patient.  This is the second of two reports.  This case is for the second dose. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 22Apr2021 at 12:30 (Batch/Lot Number: EW0161) as dose 2, single (at the age of 38-years-old) for COVID-19 immunisation.  The patient medical history was not reported. The patient did not have COVID prior to vaccination.  Concomitant medications included ascorbic acid (VIT C) and multivitamin, both taken for an unspecified indication, start and stop date were not reported.  The patient previously took Omnipaque and experienced contrast media allergy and bnt162b2 via an unspecified route of administration, administered in the left arm on 01Apr2021 at 12:30 (Batch/Lot Number: ER8734) as dose 1, (at the age of 38-years-old) for COVID-19 immunisation and experienced hot warm shot running from right pelvis down to right leg.  The patient did not receive other vaccine in four weeks prior to bnt162b2. The patient experienced insomnia leading to sleep anxiety on an unknown date.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of insomnia leading to sleep and included anxiety pills and sleeping pills. The clinical outcome of the events insomnia leading to sleep anxiety was not recovered. It was also reported the patient was not tested for COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101204737 same patient/drug, different vaccine dose/event
Approx. 12 hours, post vax, the pt began to feel her "throat close up" and felt her airway was becoming constricted. She was fine the next morning. She has had intermittent pressure in her chest with anxiety symptoms. On 12/20/01, she has an indurated red area 14mm X 14mm at the injection site with slight erythema 20mm X 18mm.
Weird taste; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 28Mar2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history included borderline cholesterol. The patient had no known allergies to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and cod-liver oil (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient had a weird taste in mouth, especially when drinking liquids. It had been 7 days already and still he had it. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of weird taste was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient said a couple days after the shot, she started experiencing rashes and welts on her neck, back, arm, legs, and hands. These will disappear and then continue to come back. She states this reaction continues to this day. She has seen a dermatologist and was placed on antihistamines, but its not fully controlling the reaction. She is also experiencing a dry cough and headaches.
She was not feeling well - vomiting, chest and upper back pain for a few hours prior to visit.   Died suddenly while workup in progress
I went to sleep feeling fine. Awoke at 4 am with Chills, fever, weakness, body aches every where, stiff neck, and anxiety. My heart feels like it?s beating really fast. I have the worst headache I?ve ever had in my life.
Patient's mother stated that patient is fine only has a runny nose and a small bruise at injection site (normal reaction). Appointment for re-vaccination is on Friday December 14th, 2018.
Previously well controlled bp on Labetalol 50 mg bid and losartan 50 mg qd.  1 day after COVID vaccine, developed headaches, nausea, swelling of the feet, and bp up to 218/104,  193/94,  194/86, 195/85. No other changes, healthy low salt diet, no other triggers.  Seen in the office on 10/10 for headache and pitting edema, w BP 221/112 , sent to ED for hypertensive emergency- labs and CT head normal. Increased labetalol to 100 mg bid, bp lowered w additional labetalol dose.  Seen again in ED 10/12 for persistently high bp and headaches. BP 187/88 in ED additional losartan dose added.  10/12 tele visit w PCP for ongoing plan:  given a day by day plan for med adjustments according to BP and tracking symptoms. Daily checkins with PCP until bp controlled on Labetalol 100 mg tid and losartan 50 mg BID.  As of 11/10 still needing higher doses for bp control. feels well
a large 7" round shape around where vax given in lt arm; had flu shots a/w/no ill effect;called MD & spoke w/nurse
Information has been received from a physician concerning a "healthy" 4-year-old female who on 08-Aug-2007 was vaccinated with PROQUAD.  It was noted that the patient received a dose of varicella virus vaccine live (MSD) at the age of 1.  On 07-Sep-2007 the patient developed chicken pox.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been received from a physician stating that they did not know who the patient in question was and therefore had no further information.
Patient presents to the ED on 03/20/21 at ~19:45 for palpitations and shortness of breath. Patient symptoms started 1 hour prior. He woke from sleep sweating, feeling short of breath and having heart pounding sensation. No chest pain. He was seen at Army clinic on base where they were concerned he was in A. fib and brought him to the ED. His VS where slightly hypertensive, tachypnic but not tachycardic with normal temperature and pulse ox. He was given 1L bolus of LR, had EKG, CXR, echo and cardiac stress test done while here. He was discharged in good condition with follow up with cardiology in 4 days for Holter monitor.
I need to take Norco for a bad back/All I need you to tell me is if I can take Norco for my back pain,  and coded to back pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 24Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient need to take Norco for a bad back,and coded to back pain. She have had a very bad back. She had the Pfizer vaccine this past Sunday. And need to if she could take Norco for her back pain. The outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.
Patient complains of shortness of breath, difficulty breathing, decreased o2, chest congestion 3 days after receiving vaccine
covid vaccine breakthrough event  dose 1 Pfizer 4/3/21  ER2613 dose 2 Pfizer 4/24/21 EW0150
Both wrist were in pain, right wrist was more swollen. Was prescribed Diclofenac Potassium by healthcare professional Pain in neck. Symptoms are currently getting worse.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Apr2022 as dose 4 (booster), single (Lot number: C41J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hemochromatosis" (unspecified if ongoing), notes: Other medical history: hemochromatosis. Concomitant medication(s) included: FENOFIBRATE; ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included patient received other medication in 2 weeks. Patient received treatment Paxlovid, treatment start date: 09Aug2022, treatment stop date: 13Aug2022. No allergies reported.
05/25/21 in EC pt. presents with progressive weakness and decreased appetite.  Per H&P: "This is a 88y.o. female who lives with son presenting with difficulty getting out of bed.  She was walking her dog 3 weeks ago and now states she cannot get out of bed.  She is denying associated symptoms she states she was vaccinated for COVID-19.  No other sick contacts or recent travel.  She has been warned by physicians she needs to increase PO intake.  She saw her PCP about 3-4 weeks ago and was given lexapro to start.  Pt did have improvement in mood last week, then felt fatigue again."
I did not feel anything shortly after the injection, but later in the evening, started to develop a normal post-vaccine soreness. I thought little of it and went to bed. I woke up just after 3am with chills, fever, and worsened arm pain, to the point that it restricted my arm's range of motion and speed of motion. Interestingly, the arm is not red or swollen, but is painful near the injection site, and the area around my clavicle on that side is somewhat swollen, but not red or painful (likely a lymph node). I was unable to get back to sleep due to these side effects (primarily chills and fever). After a few hours of trying to get back to sleep, I took some Tylenol and tried to eat breakfast. I was unable to keep much down, and had to arrange a day off of my internship, and was finally able to sleep on and off for the next few hours.  The symptoms have somewhat lessened, but have not resolved, after about 22.5 hours post-injection. I fully expect this to resolve or mostly resolve by the 48 hour mark. I mostly found this unusual due to the severity of the reaction and after only the first dose, and wondered if my young age could have something to do with the clearly robust immune response so soon after inoculation.
Pt developed headache and nausea three days after vaccine administration. Came to ER for evaluation given concern for adverse effect related to vaccine