chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed a hard time sized knot a few hours after the shot with a rash and area was itching and sore. Same thing happened after second shot in March. The knot is still present and my arm aches and hurts to lift it up and down. I have not been to my PCP yet but pain is increasing and mobility pain increasing which is why I am reporting it now.
DIZZINESS; PAIN AT THE INJECTION SITE; STOMACH ACHES; This spontaneous report received from a consumer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain cancer, and concurrent conditions included seizures, dementia/Alzheimer, and vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included levetiracetam for seizures. On 29-APR-2021, the subject experienced stomach aches. On 29-APR-2021, the subject experienced pain at the injection site. On 06-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches on 29-APR-2021, and pain at the injection site on 30-APR-2021, and had not recovered from dizziness. This report was non-serious.
About 52 hours after my second shot I started to have upper abdominal pain, nausea and vomiting, which I also had roughly 5 days after my first covid vaccine shot. Once again, the pain and GI issues that took place were similar to when I had experienced pancreatitis previously. I contacted my PCP via our patient portal, and he said to report both instances to the CDC and follow previous protocol of a clear liquid diet and rest.
Initial report was received 06 July 2009 from a consumer who is also the patient's parent. An 18-year-old male patient with a medical history of mild to moderate scoliosis and seasonal allergies, had received an injection of Menactra, lot number U2351AA (route and site not reported) on 22 September 2007, and 641 days later, his parent had laboratory titers performed which showed the patient did not have protection against tow of the serogroups. The patient had no illness at the time of vaccination and he had not been taking any concomitant medications. It was reported that the patient had not been evaluated by their physician. Laboratory testing was performed on 24 June 2009 for Meningridis A/C/W-235?Y with the following 1gG ug/mL results: Type A IgG-2.4 ug/mL, type C InG-0.1 ug/mL and Type W-135 - 1.2 -2.0 ug/mL: Equivocal, and 2.1 ug/mL or greater: Suggestive of protection. In addition, there were handwritten notes on the lab report dated 06/Jul/(year illegible) which stated, "Meningitis Bacteria, (+) immunity to meingitis Type A. Recommend infectious dx (illegible word)". No further information was provided at the time of the report. Follow up information received on 04 August 2009 from a health care professional. At the time of vaccination, the patient was recovering from pharyncitis. The patient received a first time dose of Menactra intramuscularly in the right arm, a second dose of Fluzone SV 2007-2008 (lot number U2436AA) intramuscularly in the left arm and the first does of HAVRIX (lot number AHAVB177AA) intramuscularly in the arm all received on 22 September 2007. Between November 2007 and March 2009 the patient was transferred to a new primary care physician. The patient's mother did not have the patient's records, therefore she was unsure if the patient had received the vaccine previously. Subsequently titers were ordered. The patient's mother contacted the reporter regarding the lab results. The reporter stated that the patient would have to follow up with his new physician to review the findings. Per the patient's mother, the new physician recommended that the patient follow up with an infectious disease specialist. Reovery status was not known. No additional information was provided. Follow up information received on 11 September 2009 from a health care professional who reported that the patient received  the meningococcal vaccine while in hight schoo. Titer levels were assessed to assure appropriate immunity since the patient was attending college. Based on the results, the patient was recovered from the even. No further information was provided.
This case was reported by a other health professional via call center representative and described the occurrence of passed out in a adult patient who received HAVRIX. On an unknown date, the patient  received HAVRIX at an unknown dose. On an unknown date, several hours after receiving HAVRIX, the patient experienced passed out (serious criteria GSK medically significant), arm paralysis (serious criteria GSK medically significant), numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the passed out, arm paralysis, numbness of upper extremities and tingling of extremity were recovered/resolved. It was unknown if the reporter considered the passed out, arm paralysis, numbness of upper extremities and tingling of extremity to be related to HAVRIX. Additional information was provided as follows: The age at vaccination was not reported. The healthcare professional called to report that patient received HAVRIX and less than a month after receiving HAVRIX, the patient experienced temporary paralysis, numbness and tingling of the arm. The patient passed out at work hours later. The patient had to go to the emergency room. The healthcare professional not provided any patient specific information at this time. He said he purposefully was not answering callers questions. The patient received the vaccine sometime last week and he thought it was the first dose in the series but was not sure. He said he did not have all the information available at this time but it seem this person was trying to claim Workman's compensation and that is why he was calling. He said he would be willing to provide more information if the safety department wants to follow up with him at a later time.
hands are stiff in the morning; Arthritis is gone,I feel great/better than I have ever felt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Arthritis is gone,I feel great/better than I have ever felt) and MUSCULOSKELETAL STIFFNESS (hands are stiff in the morning) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Open heart surgery 4 years ago). Concurrent medical conditions included Arthritis (Regular arthritis, not rheumatoid arthritis reported.), Atrial fibrillation, Blood pressure high and Penicillin allergy (I).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Arthritis is gone,I feel great/better than I have ever felt). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (hands are stiff in the morning). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Arthritis is gone,I feel great/better than I have ever felt) and MUSCULOSKELETAL STIFFNESS (hands are stiff in the morning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient takes two pills a day one for blood pressure and another for A.fib. she is perfect and active. no treatment information provided.
Vaccines administered after being in stored in fridge past 30 days; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medication not reported.  Treatment medication not reported.
Injection site cellulitis - warm, tender to touch, fever to 102 symptoms started 30 hrs after injection and have been progressive since onset. Tx: KEFLEX 500mg 3x/day for 10 days. Dx: at 930AM on 10/24/13.
Patient reported hands tingling. Started to feel toe tingling.  Offered Benadryl 25 mg PO, followed by another 25 mg PO.  Observed for 60 minutes and symptoms resolved.  BP 104/78. HR 94, RR 20.  Appeared slightly diaphoretic.  Drank water.  Tingling continued for about 20 minutes, then decided to take the benadryl.  BP was 114/76 on recheck, pulse 84 at about 40 minutes after dose.  Felt fine at 60 minutes and friend picking up.
Hypertensive crisis  190/120  HR 88 O2 98  c/o HA dizziness appears lethargic with glassy eyes. States he does not go to MD and takes no meds. Did not eat today. Neuro exam normal denied CP. arm pain or jaw pain. No nausea. Dizzy and unable to drive through line. Does not see spots. Called ens for HTN crisis
This spontaneous report was received from a medical assistant referring to a 83 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Redness at injection site; Skin induration at injection site; Bubble / blister at injection site; Intended to administer tuberculin; On 30Nov2021, Nurse Practitioner and reported that three patients, (Female age 56), (Female age 25), and (Female age 55) were incorrectly administered TDVAX (lot# A132A). A 0.72mL dose of TDVAX was administered to each patient via intradermal injection whereas the labeled dose of TDVAX is 0.5mL administered IM. The stated intent was to administer tuberculin testing. The errors were discovered approximately 5 minutes after the administration of TDVAX to the third patient who noted that the injection did not feel like TB test. Each patient was alerted to the error on the same day.   The next day, 30Nov2021, each patient reported injection site reactions. One patient noted redness at the injection site and the other two had slightly larger red areas with induration at the injection site. One developed a blister. Nurse did not specify which adverse reaction belonged to which patient.     Upon being asked about the site of administration, nurse stated that it involved both left and right arms, without providing further details.  It was requested of nurse to provide with the name of the facility where these events took place. Nurse refused to disclose additional information and stated that she needed to talk with her lawyer.    Note: Three separate ICSRs have been submitted to VAERS for all three patients mentioned in this case.   1. ICSR Submission Name "US-MassBiologics-AE21-06" 2. ICSR Submission Name "US-MassBiologics-AE21-07" 3. ICSR Submission Name "US-MassBiologics-AE21-08"; Sender's Comments: The adverse event reported in this case was assessed as non-serious and not used as labeled.
My arm was very stiff; This case was reported by a consumer via other manufacturer and described the occurrence of limbs stiffness in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness was unknown.   It was unknown if the reporter considered the limbs stiffness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination not reported. The patent stated that Shingles shot was horrible as her arm was very stiff after receiving shingles vaccine. The reporter's and healthcare professional s consent to follow-up was reported as not applicable. For tolerance of 2nd dose refer case US2021AMR067301; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR067301:Same reporter.
Dec,15 around closer to dawn felt left arm pit very tender can not roll on left side in bed, nausea towards daylight; Dec,16 started feeling chest pain at bedtime around 10pm; Dec,17 chest pain increase 50% at dawn, sat down on bed due to surprising pain when deep breathing or inhaling on right side of chest, continues the rest of the day and did do any activity gauging self and spoke to friend PT about my issue; Dec,18 chest pain subsided after morning rest; Dec,19 chest pain almost completely gone.
suspected vaccination failure; Shingles; Extensive rash on right arm and chest; Pain in his back around the scapula area; Sensitivity in his right forearm; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2019, the patient received the 1st dose of Shingrix. On 1st November 2020, 502 days after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, upper back pain and sensitive skin. On 5th November 2020, the outcome of the shingles, rash, upper back pain and sensitive skin were recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash, upper back pain and sensitive skin to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was a retired physician The patient received both doses of Shingrix on an unknown deltoid. The patient experienced shingles, back pain- around the scapula, extensive rash on right arm and chest (especially on pectoral region) and sensitivity in forearm. This case was considered as suspected vaccination failure since the details regarding confirmatory lab test for shingles were not unknown. The reporter consented to follow up.
Patient tested positive for covid 4 days prior to presenting to ED with shortness of breath. He was admitted and is currently undergoing inpatient treatment.
PSA tested at 31. Prior tests had PSA in 13 to 15 range. Got MRI and my prostate did not increase in size, nor was any indication of disease shown.  Blood Pressure went to 140+ over 80 Prior blood pressure never exceeded 128/78
Patient developed growing erythema, warmth and swelling burning tenderness, fatigue starting the day of vaccination and continuing on for 6 days afterwards. She also developed a rash on her abdomen that resolved and an area redness the size of a pencil eraser on plantar base of left great toe.
Patient experienced itching almost immediately. About 10-15 minutes later she had trouble breathing and her throat was swelling.
Treatment of COVID-19; Vaccine brand other=Moderna dose 3,2,1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 15:45 as dose 4 (booster), single (Lot number: GJ5342) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 at 12:00 as dose 1, single (Lot number: 001A21A), in left arm, on 09Apr2021 at 11:00 as dose 2, single (Lot number: 032B21A), in left arm and on 10Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PMR" (unspecified if ongoing), notes: PMR; "Osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Sep2022 at 15:45, outcome "unknown", described as "Vaccine brand other=Moderna dose 3,2,1"; COVID-19 (non-serious) with onset 30Sep2022, outcome "unknown", described as "Treatment of COVID-19". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19 included Paxlovid medicine 30Sep to 05Oct2022.  Additional Information: No other medication in 2 weeks was reported.
Possible cellulitis; Arm was red and swelled up, when she touched it, I had heat in it; Arm was Red and swelled up, when she touched it, I had heat in it; Arm was red and swelled up, when she touched it, I had heat in it; Arm was sore to shoulder; Sore in her arm; A spontaneous report was received from a Consumer herself concerning a 58-Year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in her arm, her arm was red and swelled up when she touched it I had heat in it, possible cellulitis, arm was sore to shoulder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 MAR 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 036A21A) via unknown route for prophylaxis of COVID-19 infection.  On 11 MAR 2021, patient experienced sore in arm and went away after two days. On 20 MAR 2021, the patient experienced arm was red and swelled up, when touched it was hot. Nurse practitioner suggested patient to apply damp warm moisture to it. They think it could be a possible cellulitis which was a serious condition as medically significant. The arm was sore to shoulder. Treatment information was provided as damp warm moisture to red and swelled up arm. Cephalexin for the possible cellulitis.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event sore in arm was resolved on 13 MAR 2021. The outcome of the events possible cellulitis, arm was red and swelled up when touched it felt hot, arm is sore to shoulder was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Lump in her right upper forearm which pt states developed a few days after vaccine. She developed swelling. Nontender to touch at painful with rotation no fever or chills or redness.
On March 6, 2021, three days after second Moderna vaccine, I had sudden onset deafness in my right ear and progressing dis equilibrium.  Within a couple of hours I could barely walk.  Extreme dizziness/vertigo, nausea.  Went to ER next day, 3/7 and was transferred after about 5 hours to Medical Center.  Was eventually diagnosed with Idiopathic Labyrinthitis.  ER wanted to admit me at 11:30pm but I hadn't eaten or had any fluids and they don't feed people in the ER so I went home.  Conditions worsened with walking like a very drunk person and brain fog, dizziness, vertigo.  Went back to ER where they completed all kinds of tests and scans.
minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips); light headed/dizzy on day 2; exhaustion for four days; intense arm pain at injection site (pain began when shot was being given); slight nausea; This is spontaneous report from consumer (Patient) via (Pfizer/Bio-Tech). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation at hospital. Medical history included restless legs syndrome. The patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carbidopa, levodopa (SINEMET), levothyroxine sodium (LEVOTHYROXIN). On an unspecified date in Mar2021, patient experienced minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea, lightheaded/dizzy on day 2. It was unknown whether patient treatment for the adverse events. Outcome for the events were unknown.  Information for lot/batch number has been requested
Itching started in the body after three days of getting the first dose of the vaccine, at first it started on my right side of the body then the next day on my left, then my arms, then my legs, and day by day it got worse, at the area where it was itching it got red and I could feel heat coming from it. Then I saw my doctor and she told me that I had an allergic reaction from the vaccine and so I can not take the second dose and then she prescribed me Prednisone 10 mg tablet to take for nine days.
Patient called today 11/2/2018 at 6 pm telling us she had adverse reaction of the vaccine that she did not have before with the first dose.The reactions lasts for 2 hrs. it was drop in Blood pressure (80/47) and body temp 96.7. She was shaking for 2 hrs and then she get better. She did take any drugs or seek any medical attention. She said she is fine now with no problems.
Per EMS, patient with complex medical history "weak and lethargic" post vaccine. She was alert enough to decline transport the first time; she agreed to transport a few minutes later after speaking to EMS control.   Vitals assessed by EMS: BP 144/42 (perhaps typo of 92); Blood glucose 450; O2 saturation 98%; heart rate 55.  See chronic conditions section for list of existing conditions.
Fever, Chills, body aches, throwing up, arm pain, swollen, and itchy around area of injection.