chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe headache; spike in blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 at 14:45 as dose 4 (booster), single (Lot number: G12042) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "fast heartbeat" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: ALLOPURINOL. 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. The following information was reported: HEADACHE (non-serious) with onset 22Jun2023 at 02:00, outcome "recovered" (Jun2023), described as "severe headache"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Jun2023 at 02:00, outcome "recovered" (Jun2023), described as "spike in blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, blood pressure increased. Additional information: the patient experienced severe headache and spike in blood pressure 30 to 36 hours after vaccination. AE treatment: Ibuprofen, extra dose Losartan.
Information had been received on 18-JUL-2016 from a nurse practitioner regarding a 55 year old female with high blood pressure, depression and allergies to BIAXIN and sulfa drugs. On 15-JUL-2016, patient had been administered an unspecified dose of ZOSTAVAX (lot# M001747, expiration date 07-APR-2017) subcutaneous at an unknown pharmacy. Concomitant medications included multiple unknown medications. Nurse practitioner reported that on 16-JUL-2016, patient developed an area of 16 cm by 7 cm of redness and warmth and in the central area of the rash there was a vesicular type rash which was located on the back of the patient's right arm. Patient also had an unknown fever. Nurse practitioner reported that from 16-JUL-2016 to 17-JUL-2016, the patient got worse as she had the fever both days and more vesicles showed up on the patient's arm. On 18-JUL-2016, patient presented for follow up on the administration of ZOSTAVAX and she did not have any fever and no new vesicles developed on her arm. No additional information was provided in regards to this adverse event. During the conversation, nurse practitioner also reported that multiple unknown patients were administered an unspecified dose of ZOSTAVAX (unknown lot#/expiration date) on multiple unknown dates (MARRS# 1608USA014081). The nurse practitioner reported that on multiple unknown dates following the administration of ZOSTAVAX the multiple unknown patients then developed a "small injection site reaction or rash". No additional information was provided in regards to this adverse event and no further details were provided regarding these patients. This is one of two reports from the same reporter. Additional information is not expected.
Pain at injection site Bruising at injection site Headache  Joint pain Fatigue  Muscle pain
Vaccine administered on 3/17/03. On 3/18/03, she reported injection site was sore and she had a temperature of 100F. She was advised by MD to apply cold pack to area and use Tylenol.
Called in to assess patient. Per daughter, " she was feeling jittery and had blurred vision earlier but she said she's feeling better now ". Patient denied dizziness/ headaches/ shortness of breath. BP noted to be elevated at 230/93, HR = 100, SaO2 = 98%. Rechecked after a few minutes still elevated. BP = 223/105, HR = 93. Seen by nurse practitioner on duty with instructions to take patient to urgent care if BP is still above 180 systolic. Patient taken to the urgent care reception accompanied by daughter. Warm hand off to RN on duty. Last V/S prior to transfer - BP = 230/80, HR = 81. No distress or discomfort.
The patient received Gardasil #1, Tdap and meningococcal conjugate vaccine (ACYW-135) on 01June 2009 -- administered at Pediatrics in facility.  On 23June she started having painful and blurred vision in the right eye, she was evaluated by us in the Pediatric Neurology clinic on 26June and found to have right optic neuritis.  Brain MRI showed periventricular white matter hyperintensities, one with enhancement.  She was admitted for IV steroids. The DDx includes multiple sclerosis vs demyelination triggered by the immunizations.  7/14/09 MR received for DOS 6/26-28/2009 with D/C DX:  Optic Neuritis (R retrobulbar).  Pt admitted for IV steroids for 4 day hx of blurry vision, vision loss, eye muscle strain and pain.  Neuro consult c/w ON. Will continue to watch for further signs of MS. Tx with IV steroids and d/c on steroid taper.
Pt recvd 3 doses Hep B & 24JAN92 had neg titer & a heart attack 31DEC91; pt adm to hosp 2JAN92 w/retrosternal pressure-like discomfort; Seen in ER adm to CCU; had non Q wave MI; AV block; exp complete AV dissociation; angina, pain, vomit;
Severe headache, muscle ache, fever, servere vomiting, these lasted for 5-6 hrs.
my speech was slurred; I couln't stand up - my legs felt rubbery; chills; fatigue; fever (102°F); This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, DYSARTHRIA (my speech was slurred), LIMB DISCOMFORT (I couln't stand up - my legs felt rubbery), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever (102°F)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 102°f (High) 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Swelling and redness at site of DTaP and HIB vaccine that occurred the night after getting vaccines. Patient went to ED next day because of worsening redness and adx with cellulitis and started on BACTRIM. Mom states area has improved. Patient is ambulating well with no issues. Did have 101 fever Tuesday night and 102 fever 24 hrs ago, but no other fevers. Mom states redness had spread to almost entire thigh, but not beyond knee and hip joints. APPEARS TO BE LOCALIZED REACTION TO DTAP VACCINE, NOT ALLERGIC REACTION. REDNESS AND MASS HAS DECREASED, PER MOTHER. ED DX WITH CELLULITIS, WHICH IS POSSIBLE, BUT NOT PROBABLE. TOLD MOM TO CONTINUE ANTIBIOTIC THAT WAS RX'D AND REASSURED THAT REDNESS SHOULD CONTINUE TO IMPROVE. TOLD HER THAT CYSTIC MASS SHOULD ALSO IMPROVE, BUT MORE SLOWLY AND MAY TAKE WEEKS TO MONTHS TO COMPLETELY RESOLVE. RTC FOR WORSENING, PERSISTENT FEVER, REFUSAL TO WALK. WILL REPORT REACTION TO VAERS.
Patient had a welt at the injection site the size of a nickel on 07/31/2018, at 7 p.m. At 11:00 a.m. on 8/1/218 the welt was the size of a baseball. Raised red bump, not warm to the touch. Patient able to move arm without difficulty. Denies SOB, trouble breathing, or swallowing.
PROQUAD was administered after it experienced a supported temperature excursion; No side effects/No additional AE; This spontaneous report was received from a nurse referring to a 12 year old patient of unknown gender. The patients concurrent conditions, medical history and concomitant medications were not provided.    On 11-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, route, frequency, were not provided) 0.5 mL for prophylaxis; Lot No. X009734 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported as 30-SEP-2024, and upon internal validation established as the same.  It was stated that no lot information was provided for properly stored sterile diluent used to reconstitute the improperly store vaccine.  The nurse reporting that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered after it experienced a supported temperature excursion (incorrect product storage). The vaccine presented a temperature excursion with a temperature of -9 degrees Celsius, with a time frame of 4 hours, 30 minutes. There were no previous temperature excursion. Moreover, it was stated that the sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. No side effects were reported and no additional adverse event (AE). No additional information was provided.
Daily headaches, which I never had before. Advil has helped to some degree, but is less effective over time.  Chest pain when lying on my left side. Never had this problem before. Nothing seems to help. At times I've had to bend over to get a breath.
Hospitalization 9/27-9/30 for COVID, shortness of breath. Treated with dexamethasone 6  mg IV daily, Remdesivir, and baricitinib.
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patients received expired doses from the lot numbers 013f21a, 031h21a, 059h21a. No concomitant and treatment medications were reported by the reporter.
Information has been received from a health professional concerning a female who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently, the patient developed blood clots in her legs. It was reported that the patient was treated by her primary care physician. The patient's outcomes was unknown. Additional information has been requested.
Metallic taste; Hot flashes; Headache; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 10May2021 at 13:15 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID vaccine. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) for unknown indication from an unknown date and unknown if ongoing. The patient previously received clarithromycin (BIAXIN) for unknown indication from an unknown date and experienced drug allergy and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. On 10May2021 at 17:00, the patient experienced metallic taste, headache, hot flashes and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste, headache, muscle aches and hot flashes was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt called today saying she has a rash and hot to touch at injection site. pt received both spikevax and flucelvax in the left arm
Three days after receiving first vaccine, I woke up with fasciculations in my left lower lip. The twitching was visible standing 2 ft from my mirror. It lasted approx 30min then spontaneously resolved. No other symptoms.
cardiac amyloidosis; Dilated cardiomyopathy (I42.0); left ventricular hypertrophy (LVH); has increased on fatigue; cannot take breath well occasionally on exertion; abdominal swelling; weight gain/ weight had increased from 217 lbs to 227 lbs; dry cough since Covid shot; This is a spontaneous report received from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for Covid-19 immunization on an unspecified date. He reported that on 27Mar2021 he got the 2nd COVID Pfizer shot and has increased on fatigue now and cannot take breath well occasionally on exertion, also reported some abdominal swelling, none in legs. He reported weight gain but can la flat and no issues on resting conditions. He also reported dry cough since COVID shot but did not have any of such issues after the 1st dose. No fever, no dizziness or passing out. Diagnosis: Dilated cardiomyopathy (I42.0) -Left ventricular ejection fraction (LVEF) 25-30. Left ventricular hypertrophy (LVH) was diagnosed with cardiac amyloidosis. His weight had increased from 217 lbs to 227 lbs - reported shob but no edema, they discussed increasing furosemide (LASIX) to 40/d from 20 daily for a week and reassess. Also suspect COVID vaccine related immune phenomenon. Treatment received for the events (Dilated cardiomyopathy, Left ventricular hypertrophy, cardiac amyloidosis and weight gain). Events (has increased on fatigue, cannot take breath well occasionally on exertion, abdominal swelling, weight gain and dry cough since COVID shot) onset date was on unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported cardiac amyloidosis, Dilated cardiomyopathy, and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information on the patient's medical history, underlying medical conditions would be helpful for the Company to make a more meaningful causality assessment.   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 RA, IEC, as appropriate.
Irregular menses, PMS mood symptoms  cramping, bleeding still and no sign of slowing down. Headaches daily.
I received the vaccine at a Department of Health vaccine clinic at the Hospital. About 25 minutes after receiving the Janssen vaccine, my face became flushed (red) and I felt weak. We were in the hospital parking lot and drove to that hospital's emergency room, where I was evaluated. After several tests (item 18) I was declared okay and left after 3 hours with no further intervention. I probably should have taken a Benadryl (diphenhydramine) after the shot to prevent such a reaction.
Myalgia, Fever, chills, weakness, fatigue and brain fog.  Narrative:
- immediately after vaccine -- redness in face, heaviness in arms and legs. nurse gave me Zyrtec and I was ok after 45 min - evening of shot -- typical flu response, felt sick, by next day had 103 degree fever - day after shot afternoon -- developed swelling sensation in throat, hard to swallow. Took another Zyrtec and it went down a bit. - headache persisted throughout week after shot on left side of head - day 9 after shot headache got extremely bad, throbbing pain in head on left side, electric jolts through head - day 10 took excederin migraine to relieve headache pain, made head throb and pulse and face went numb on left side and left arm numb - bad headache continued day 9 - day 13 after shot, mostly on left side of head - also developed spasm in chest at night mostly when lying down, feels like a motor running that sometimes turns off (still happening at 3 weeks) - day 14 after shot headache continued, now on both sides all day long, pressure behind earns, sometimes behind eyes, top of head - day 18 morning took Advil to relieve headache pain, developed numbness in face and difficulty swallowing - current (almost 3 weeks after shot) still have headache, afraid to take pain meds, seeing neurologist in a week
first night had chills, and didn't feel well, got off sofa and crawled into bed. had chills. around 9:00 pm. took Tylenol and around 4:30Am  still has chills and ran fever of 103.1 and took more Tylenol. woke up about 6:30Am  and felt better. chills were gone but still didn't feel well.  Called Dr. but have not heard back. currently 3:00 pm  starting to feel chilled again.
Itchy red hives on face and arms, hoarseness of voice, cold sweat, diarrhea.
On day 8, I noticed a red, raised area about an inch below the injection site. The area was about 2 inches in diameter and warm to the touch. It was itchy and sore.   There was a knot in my armpit and my arm was very sore from my armpit down the underside of my arm to my elbow.   The next day the red rash had grown to about 4 inches in diameter. The soreness and swelling in the armpit continued to worsen.   The rash went away after 4 days but the swelling on the lymph nodes in the arm pit and soreness under the arm towards the elbow have worsened.
All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting.  Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair.  Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583.  Resident deceased upon re-check after calling PCP to report status change.
Woke up with a charley horse in my right calf and then began have random little leg cramps that alternated legs and places in my legs ex: right calf, then back of left thigh, then my inner thighs. It begins just randomly and ends fairly quickly. Then when I sit down afterwards my muscles in that area begin jumping (not hard) I have had a few times that this happened in my biceps as well.
Pt received ZOSTAVAX vaccine on 6/10/09 - RTC on 6/12/09 C/o pain, red, warm to touch at injection site. Advised warm compresses. Given RX for Duricef X 10 days.
Lymph node on right side of neck became swollen and sore after 2nd dose of covid  vaccination. Was noticed 2 days after vaccination and is still current on  day 4.
Severe red itchy rash over torso, front & back, arms, thighs Waves of chills on a constant basis, but no fever Tired, lethargic, unable to think clearly This is the 5th day since receiving the vaccine Have taken doses of 50 mg of Diphenhydramine HCL, 12-hour Claritin, Famotidine 20 mg, acetaminophen, Triamcinolone Acetonide ointment to relieve itching, Epsom salt & soda baths  Still have the bad red rash-woke up in the night at 2 am and could not sleep because of itching
10 minutes after the patient received her vaccination, she experienced a tingling sensation on the left side of her abdomen.  When she stood up, she experienced a sharp pain on the right side of her abdomen.  The tingling sensation lasted ten seconds and the pain lasted a brief moment (a second or two).  She denies constipation or diarrhea.
Patient was brought to ED due to shortness of breath, cough, and worsening confusion. He was hospitalized and died. Patient was fully vaccinated.
This spontaneous report as received from the physician assistant, refers to a patient of unknown age and gender. On 23-JUN-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot# not reported, expiration date 30-APR-2014), .65 ml, subcutaneous. No adverse effects reported. Additional information is not expected.
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from reporter stated as other and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 17-DEC-2021, the patient was vaccinated with an improperly store measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) (strength, dose, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number T033814 had been verified to be a valid number with an expiration date reported and established as 05-OCT-2022) for prophylaxis (product storage error).   The vaccine underwent a temperature excursion that was reported as following: above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that the suspect vaccine did not had a previous temperature excursion. No additional adverse effect was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Currently have shortness of breath, chest pain, fatigue, nausea, body aches, joint pain, and injection site pain.