chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADVERSE REASTION after BOOSTER, patient COVID test is (-)  Patient is a 65 year old female with PMH HTN, HLD, thyroid cancer with thyroidectomy, and lung cancer with right lung lobectomy who presents with complaints of multiple episodes of coughing up blood. History is obtained with her sister-in-law at the bedside. As per patient, she received her Moderna booster yesterday at 9:30am. At approximately 10p patient had c/o feeling cold with chills and congestion and went to bed. Patient states that she woke up at 2am and began coughing up blood approximately 5 times in an hour which prompted her to come to the ED.
1. Nonintractable headache, unspecified chronicity pattern, unspecified headache type    2. Unstable gait    3. Upper extremity weakness    4. Hypertension, unspecified type    right frontal lobe nonspecific attenuation which could be a CVA (abnormal CT, needed MRI) MRI revealing multifocal areas of right ACA territory infarct.   Ischemic stroke
Patient got Moderna vaccine on 02-08-2021. Around 5:00 PM his arm was getting sore and was sowllen ( he said it was like a bump). He stated his temperature was 100.8. He denied any other symptoms. RN reviewed taking Tylenol or Advill, keep hydrated, monitor his temperature. RN reviewed moving arm, using cool compress on it. RN stated will follow up with him the next day.
Vaccine manufactured expiration 8/31/22. Vaccine was administered to patient on 9/14/22 after expiration. No adverse reaction reported by the patient.
10 days post vaccination - client has rash (which started at administration) on her back, arms and under chin.
Patient has redness, tenderness, swelling and peeling skin at injection site on right arm.  Patient stated that she had soreness after the first shot for about 3 days.  The second shot is still painful to the touch 14 days later.  Patient also stated that she is having headaches every day for approximately 1 - 2 hours each.
Severe, RAW dry mouth of back of mouth & dry tongue. No saliva. Painful to eat, constant need to drink water to lubricate mouth. Burning sensation of top mouth, irritated, red & painful. This lasted for a week or longer.
30 SECS: HEAVINESS IN LUNGS, REDNESS IN FACE AND HOT/SWELLING FEELING 2 MINS: MOVED FROM FACE TO LOWER BACK WITH MUSCLES SPAMS AND FEELING OF EXTREME DISCOMFORT - FACE DID COME BACK TO REGULAR COLOR 4MINS: LEGS AND ARMS HAD A TINGLING/NUMBNESS FEELING  THAT LASTED FROM ABOUT 5 MINS - NO DIZZINESS - WAS ABLE TO STAND AFTER BACK SPASMS AFTER 10 MINS WAS BACK TO NORMAL WITH NO SIDE EFFECTS OCCURING
Teeth hurt; Fast near beats; Diarrhea; Migraine; Sleep; Heavy onset of period; Weakness; Leg pain; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer. 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 receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 14Apr2021 at 01:00, the patient experienced teeth hurt, fast near beats, diarrhea, migraine, sleep, heavy onset of period, weakness, leg pain and nausea. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not 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 teeth hurt, fast near beats, diarrhea, migraine, sleep, heavy onset of period, weakness, leg pain and nausea were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
throat infection; sore throat; a bit of soreness of the arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Information Team for a Pfizer sponsored program. The reporter is the patient. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergies" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PHARYNGITIS (non-serious), outcome "unknown", described as "throat infection"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a bit of soreness of the arm". Therapeutic measures were taken as a result of pharyngitis. Additional information: Treatment for pharyngitis included antibiotics prescribed 4 months ago but were never used. The patient will continue taking the antibiotics until 06Mar2021, for a 7 day period, twice a day (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: Pt is a 89y.o. male who died on 04/16/2021 w/ h/o DM, CVA, CKD-3 (bCr 1.8-2), CAD s/p CABG '08, OSA, HTN, HFpEF, aortic valve stenosis, Afib s/p pacer now on Eliquis, CG5 prostate cancer s/p XRT '19 now on total androgen blockade now with locally-advanced & metastatic castrate-resistant prostate cancer, LEFT hydroureteronephrosis 2/2 locally-advanced disease s/p silicone 6x26 stent 12/2020. Pt received Moderna Covid-19 Vaccination 2/2 on 02/19/2021. Pt presented to ED on 04/04/2021 with painful hematuria. Palliative care and patient admitted for hospice care 04/05/2021. Pt died inpatient on 04/16/2021 with physician reporting "Death was caused by: Metastatic prostate cancer complicated by acute renal failure". Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
Patient told family members he received second dose of Pfizer-BioNTech COVID19 vaccine on April 18, 2021.  Sheriff's Department contacted next of kin on morning of April 20, 2021 stating that patient had died suddenly on April 19, 2021.
pt devel t104 & crying that would not stop, rt leg red, hot & hard; pt would not move the leg during hospital stay; family MD saw pt & placed pt in hosp x 24hrs for observation; no residual effect now noted on pt;
This case was reported by a physician via call center representative and described the occurrence of uveitis in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included herpes zoster dermatitis (distant history of herpes zoster vaccine dermatitis on arm). Concurrent medical conditions included hypertension, cardiac arrhythmia, hypothyroidism and drug allergy (horse serum allergy). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced uveitis (serious criteria GSK medically significant). On an unknown date, the outcome of the uveitis was unknown. It was unknown if the reporter considered the uveitis to be related to SHINGRIX. This case was reported via Webform. The patient did not had any history of iritis or uveitis. The patient was not immunocompromised. The patient experienced unilateral uveitis, the day after SHINGRIX administration. The reporter enquired, whether the uveitis was secondary to immune reaction to Herpes zoster antigen, as he had one mild uveitis case in the past after ZOSTAVAX vaccination, but this reaction was severe compared to the ZOSTAVAX vaccination.
upon discharge noted redness and warmth to left arm from top of shoulder to elbow area . patients cheeks red and flushed. mother concerned about warmth at site. no swelling noted. Dr came in immediately  to  exam patient. No distress noted. no sob , no dizziness. or problems breathing., no tongue swelling.  Benadryl was given to patient per providers order, and patient remained in clinic, for further observation. patient denied and symptoms upon discharge, and redness to face and arm improving . Mother was educated in detail to call 911 or go to nearest emergency room with a  new onset of symptoms or concerns.  Patient was discharged to home per provider. and denied any distress prior to leaving clinic.
Bells Palsy started within week after 1st covid vaccine.  This has required medical treatment
A report was received from a consumer on 11/21/03 concerning a 9 year old female vaccinee who experienced hives the night after receiving Fluvirin on 11/20/03. On 11/20/03 the vaccinee received Fluvirin and that night developed red bumps or hives that resembled bug bites. Hydrocortisone was applied to the affected area. On 11/21/03 the vaccinee developed more hives which were larger in size. The hives were treated with diphenhydramine hydrochloride. The vaccinee previously received a dose of the influenza vaccine for the past two years without any problems and has no history of hypersensitivity. The reporter did not know the outcome of the hives at the time of the report. Update 2/16/04: Follow up information received from a health care professional indicated that the vaccinee developed abdominal hives on 11/21/03 following administration of Fluvirin. The event resolved on an unspecified date. Follow up pending.
This spontaneous report as received from a nurse refers to a 6 year old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2016, the patient was inadvertently administered a dose of GARDASIL 9 instead of VAQTA.  No product confusion occurred. No adverse effect reported. Additional information has been requested.
Severe tinnitus; already suffering from tinnitus, but it has suddenly become much, much worse. No treatment has yet been sought.
arm was sore for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for 2-3 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for 2-3 days). At the time of the report, PAIN IN EXTREMITY (arm was sore for 2-3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No specific adverse event reported.  Route subcutaneous.  Should have been intramuscular.
Heart palpations and tingling all of the body took 2 Benadryl within 2 hr. period.
Pain left deltoid radiating to clavicle and fingers.  Later developed chest pains/mid-epigastria pain.  Persistent feeling of dizziness, leg aches 1 month later.  TC to PCP.  Lot numbers obtained and updated in database.  Child Dxd with "teen fibromyalgia" per office note of 12/27/2007.
Face and arms visibly flushed. HX hypertension. No difficulty breathing or tightness in throat.  Vital Signs: BP 150/80 HR 72 O2Sat 97%  Skin Signs: Warm and dry, Other - Very red and flushed warm to touch  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  No increased res. effort  Initial treatment: Continue observation. Patient observed to be flushed prior to vaccination. HX of rosacea. Patient states HX of sun exposure prior to clinic.  11:13 AM  Vital Signs: BP 138/74 HR 76 Resp. 16-18 O2Sat 95% Possible irregular HR noted while getting BP  Skin Signs: Other - Flushed A/Ox4  Circulation: Cap refill >2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Observation. No increased res. effort. Neg S/S anaphylaxis.  11:19 AM  Vital Signs: BP 122/80 HR 78 Resp 14-16 O2Sat: 95%  Skin Signs: Warm and dry, Other - Flushed A/Ox4  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Notes:  Vitals at 11:32 AM BP 130/72 HR 81 O2Sat 94% Lung sounds clear bilaterally Resp 16  Patient states no dyspnea upon sitting. Cap refill <1sec No nausea Patient instructed to update son. Released home by self.
This spontaneous report as received from a physician via a field representative on 06-NOV-2014 refers to a 12 months old patient of unknown gender. On 13-OCT-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K003420, expiration date: unknown) 1 shot, injection in the left thigh. Other suspect therapies included VAQTA (strength, dose, route and lot# were unknown) started on 13-OCT-2014 (also reported as on the same date). On an unknown date of 2014 the patient developed a varicella-like blister at injection site after receiving VARIVAX (Merck). No lab diagnostics studies performed. The outcome of the event was not provided. Additional information has been requested.
Rash on tops of hands that hurts. Dr thinks contact dermatitis so she prescribed topical steroid cream.
p/vax pt exp raised deep pink rash from elbow to shoulder on inj arm; inj arm achiness; shooting pain in neck & back; severe h/a; & achy joints;tx--ibuprofen;
Information has been received from a physician, via company representative, concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not informed. On 19-MAY-2014, the patient was vaccinated with an improperly stored dose of VAQTA "50U/1 ml, 1", lot # K003114, expiration date on 15-JAN-2016, (therapy route was not provided). Concomitant therapies were not informed. The reporter stated that the excursion duration was 168 hours and the lowest recorded temperature was 33 degrees F (0.55 degrees C). The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were adverse effects reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information is not expected as no further information is available.
Six hours after receiving vaccination, I developed a low grade fever, muscle aches, restlessness and vomiting. Symptoms lasted 18 hours and within 24 hours of vaccination completely dissipated.
Breakthrough case admission after 2 vaccines  Pfizer 3/17/2 Lot# En6200;  Pfizer 4/9/21 Lot# En6206
vaxine kill my Mother; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "vaxine kill my Mother". The reporter stated as follow: I'm very sorry for this inconvenience but your vaxine kill my Mother and I'm holding you and your company responsible for her death there was absolutely nothing wrong with her until she had your jab and you can say now it's age or underlying conditions. Please if you have any queries feel free to contact me on my cell phone if not I'm taking it as a acknowledged of guilt on you behalf. The patient date of death was unknown. The reported cause of death was "vaxine kill my Mother". It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: vaxine kill my Mother
Information has been received from a nurse practitioner through the patient's mother concerning her 19 year old daughter with an allergy to penicillin and sulfanomide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL (Lot # 659055/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included LEVORA. Approximately two weeks after receiving the first dose of GARDASIL the patient experienced swelling of lips. Approximately two weeks after receiving the second dose of GARDASIL the patient experienced more severe swelling of lips, swelling of the face and swelling of the hands. The patient was treated by an unspecified primary care physician after the second occurrence of swelling with unspecified steroids. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/5008. Initial and follow up information has been received from a nurse practitioner through the paitent's mother concerning her 19 year old daughter with an allergy to penicillin and sulfonamide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL vaccine (Lot # 659059/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL vaccine (Lot # 539657/1487U). Other medication included 10 mg PO LEVORA started on02-JAN-2008 for dysmenorrhoea. Phone call from patient's mother on 09-APR-2008 indicated that the patient has swelling of lips 2 weeks after vaccine (16-JAN-2008). The second dose of the vaccine, 2 weeks after injection (19-MAR-2008) the patient noted swelling of lips, face and hands. The patient was treated by an unspecified primary care physician after the second occurrence of swellilng with prednisolone. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested.
Information has been received from a health professional concerning a 23 year old male with a morphine allergy and no pertinent medical history, who on Dec 13 2005 was vaccinated with a 0.1ml intradermal injection in the right forearm of Pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). There was no concomitant medication. About 12 hours post vaccination, on Dec 14 2005, the patient developed severe arm pain and noted two red streaks on his arm. Each streak was 1/8" wide and 1-2" long. One was near the injection site and one was on his bicep. The patient also developed swelling of his axillary lymph nodes on the same side as the injection. The patient was admitted to the hospital and was started on IV antibiotics. At the time of the report the patient was recovering. There were no laboratory or diagnostic test performed. No product quality complaint was involved. No other information was provided. The event was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Blisters; itching; pain on left hand; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Er8732; Expiration date was not reported), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 40-years-old) as first dose, single dose for COVID-19 immunization. Medical history included arthritis, colon polyps, PTSD, ADHD, bulging disc and depression; all from unknown date and unknown if ongoing. Concomitant medications included hydrocodone and zolpidem tartrate (AMBIEN); both taken for an unspecified indication, start and stop dates were not reported. The patient previously took metoclopramide (REGLAN) and experienced drug allergy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 08Apr2021, the patient experienced blisters, itching and pain on left hand. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment with steroids pills, steroids shot and 4 creams were taken as a result of the events. The outcome of the events was not recovered. The patient was vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ew0161; Expiration date was not reported), via an unspecified route of administration on 27Apr2021 (at the age of 40-years-old) as second dose, single dose for COVID-19 immunization.
body aches; fever; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness). In February 2021, PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
9/13/21: Patient arrived at the ER due to shortness of breath getting progressively worse over the last 3 hours. Patient was given breathing treatment at home by family, with no improvement. She just also received her flu vaccine on 09/10/2021.  She endorses mild fevers at home. Patient received first dose Pfizer vaccine on 3/15/2021 Lot # EN6198 and the second dose on 4/05/2021 Lot # EN62060
large swelling and pain at injection site, severe headache, shoulder and neck soreness, joint pain beginning approximately 16 hours after injection lasting until approximately 30 hours after injection, @approximately 40 hours upper right lip swollen for approximately 15 hours
several people got sick after getting 2nd dose; 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 ILLNESS (several people got sick after getting 2nd dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced ILLNESS (several people got sick after getting 2nd dose). At the time of the report, ILLNESS (several people got sick after getting 2nd dose) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was provided   This case was linked to MOD21-070120,MOD-2021-068974 (E2B Linked Report).; Sender's Comments:  MOD21-070120:Crosslink MOD-2021-068974:Crosslinked
6/5/21 NO SYMPTOMS RIGHT AFTER SHOT, NO SORENESS.  6/13/21 SHE STARTED TO FEEL MUSCLE ACHE ON RIGHT FOOT, COULDN'T WALK. DR AWARE OF THIS SYMPTOMS AND DR THINKS IT MAY HAVE BEEN CAUSED BY HER MEDICATIONS. DR STOPPED FENOFIBRATE AND LOWERED DOSE ON ATORVASTATIN. ALSO DOING LAB TESTS
A physician reported that a 6 month old infant, born at 25 weeks gestation, received Prevnar and Infanrix (SKB) vaccines on 8/16/00. Approx. 24 hours, post vax, the infant developed a red rash on the face, thighs, and lower abdomen.
Adverse reaction occured at about 1:30 pm. Pt felt light headed, experienced pain on both sides of abdomen, and began experiencing trouble breathing. I then administerd 50mg of diphenhydramine IM. 911 was called and was taken to coryell memorial hospital. After diphenhydramine was given, trouble breathing subsided but patient still felt faint and cold.