chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a doctor of pharmacy student concerning an inpatient (age and gender unknown) who on the "past week or two", on approximately 14-JUN-2006, was vaccinated intramuscular with a 0.5 mL dose of Pneumovax 23 (Lot # unknown) while in the hospital. The student reports a hospital patient was on eptifibatide (INTEGRILIN) drip and heparin for myocardial infarction. Prior to this admission the patient was on warfarin sodium (COUMADIN). While in the hospital the patient received Pneumovax 23. A hematoma developed at the vaccine injection site within a few hours. The patient remains in the hospital. No product quality complaint was involved. Additional information has been requested.
redness; Fibromyalgia worsened; vaccination site pain; 1 day; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened), FATIGUE (fatigue), PYREXIA (1 day) and VACCINATION SITE PAIN (vaccination site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042A21A and 025A21X) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety and Fibromyalgia. Concomitant products included LORAZEPAM for Anxiety and Sleep disorder, TRAMADOL for Fibromyalgia.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). On 14-Apr-2021, the patient experienced PYREXIA (1 day). On 23-Apr-2021, the patient experienced ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened) and VACCINATION SITE PAIN (vaccination site pain). The patient was treated with LOSARTAN at a dose of 1 dosage form; PROPRANOLOL at a dose of 1 dosage form and FUROSEMIDE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened), FATIGUE (fatigue), PYREXIA (1 day) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: 145/115 (High) 145/115 mmHg. On 13-Apr-2021, Body temperature: 100 (High) 100F. On 28-Apr-2021, Blood pressure measurement: 118/93 (Inconclusive) 118/93. On an unknown date, Blood pressure measurement: 115-125/90-95 (Inconclusive) 115-125/90-95 and 160/115 (High) 160/115. On an unknown date, Heart rate: 110 (High) 110 and 135 (High) 135.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-095389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Lab data updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095389:
Blood clot in right calf; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOPHLEBITIS SUPERFICIAL (Blood clot in right calf) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced THROMBOPHLEBITIS SUPERFICIAL (Blood clot in right calf). At the time of the report, THROMBOPHLEBITIS SUPERFICIAL (Blood clot in right calf) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory investigations were provided. The Treatment information included rivaroxaban (Xarelto).  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated Vaccine information and added batch/Lot number, expiry date. Updated  event to blood clot in right calf. Added treatment medication.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
(R) arm became severely painful, induration. erythematous; next day measuring 4 inches diameter; diameter was serpiginous in shape; ice-burned areas; 3 days later swelling subsided, pruritus developed.
injection site was black and bluish; itched all day - at injection site; hot; pain down my arm - left arm; felt something in throat; red at the injection site about the size of a quarter appeared and very red; lump at the injection site about the size of a quarter, lump got bigger - size of baseball; felt as if going to faint; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt as if going to faint), VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red), VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball), VACCINATION SITE PRURITUS (itched all day - at injection site) and VACCINATION SITE WARMTH (hot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LL0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LOSARTAN, METFORMIN, RIZATRIPTAN BENZOATE (MAXALT), ONDANSETRON (ZOFRAN MELT), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PROBIOTIC 10, ESCITALOPRAM OXALATE (LEXAPRO), VITAMIN D3 and SUCRALFATE (CARAFATE) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PRESYNCOPE (felt as if going to faint). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red) and VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itched all day - at injection site), VACCINATION SITE WARMTH (hot), PAIN (pain down my arm - left arm) and OROPHARYNGEAL DISCOMFORT (felt something in throat). On 25-Jan-2021, the patient experienced VACCINATION SITE BRUISING (injection site was black and bluish). At the time of the report, PRESYNCOPE (felt as if going to faint), VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red), VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball), VACCINATION SITE PRURITUS (itched all day - at injection site), VACCINATION SITE WARMTH (hot), PAIN (pain down my arm - left arm), OROPHARYNGEAL DISCOMFORT (felt something in throat) and VACCINATION SITE BRUISING (injection site was black and bluish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Benadryl and Famotidine.
Patient received his first dose of Moderna vaccine and was sitting down during the 15 minute post vaccine observation when he fell off the chair and fainted. Patient was unconscious for less than a minute. Once he recovered patient denied having any medical conditions or previous episodes of fainting after vaccines. Patient's blood pressure was taken (112/70) and 911 was called. Patient was transported to the hospital for further assessment by the first responders at around 5pm.
03/23/2009 the rash began as a nickle sized raised bump with a darker center (like purple), patient is very aggitated, had yellow soupy diarrhea and very sleepy. The rash is hot to touch. Called clinic at 3:00 PM. Clinic said they would talk to the nurse and the nurse would call back. The clinic was called again at 5:00 and they said the nurses are now gone and call ER.  03/24/2009 the rash is now the size of a silver dollar and darker red with a center (whitish.) Clinic contacted again at 8:30. The clinic said we are too busy and not to come in. After threatening with a lawyer the clinic then said come in. 9:00 check into clinic. A nurse came and assessed the rash and said it concerned her, but she wasn't a pediatric nurse. This nurse left and got the doctor and talked to another nurse who was a pediatric nurse. Dr. determined it was an allergic reaction. Following this the staff was trying to determine what was actually administered into the left leg with the rash. One nurse stated several times that she was sure this was a polio shot. The mother brought the shot record to be reviewed, which at that time was determined to 'possibly' be a MMR because he did not actually receive a polio shot after all. (The record was stamped on the wrong line in the clinic records, but not on the shot record.) The mother was intructed to put on a Benadryl cream with no dosing instructions and a hot compress and to use a hydrocortisone cream and some calamine lotion. Mother is to return to clinic if leg starts to ooze or look worse. Around 11:00 the rash began to look like a target with a red outer ring, white inner ring and the red center. There is now developing a 5 inch by two inch reddened area to the back, just above the right buttock region. And there is now a red rash, warm to touch and is raised off the skin on the chin and left cheek.
Patient was lightheaded and felt flushed following vaccination. Patient recommended to place head between legs and was monitored for 30 minutes following administration without further issues.
pt recvd 1st dose of HEp B vax on 6MAR92 & pt exp pain @ inject site; pain gradually spread throughout upper arm; shoulder pain was assoc w/dec ROM; arthritic pains & dec ROM; tenderness & dec ROM in lt wrist;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: Gj5342) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: En6208), in left arm, on 01Apr2021 as dose 2, single (Lot number: Er8732), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: Fw0172), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: Fj4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
This 29 year old male, received five (5) AVA vaccinations starting 5/17/1999, 6/1/1999, 6/15/1999, 11/29/1999 and 5/12/2000. He is concerned about onset of peeling hands/feet during this time frame. The following review was completed with a comprehensive medical record review as patients' memories of events (onset, timing, triggers, where about, etc in relation to vaccine administration and symptom onset are vague). This individual reported the onset of small tender itchy "blisters" to his left foot (sole and 3rd interdigital space) that began in July 1999; and 34 days after receipt of his third AVA vaccine (6/15/1999). The skin was dry with scales but had had a clear discharge when blisters broke. He described blisters as a small pimple like bump that broke causing further blisters in clusters around central area similar to initial blister. He was diagnosed and treated for tinea pedis. He continued treatment with Mycelet 1% until September 1999 with varied responses, when these blisters spread to bilateral fingers, toes, anterior/posterior hands/feet, forearms, trunk back and thighs. There were blisters to groin region for 2 weeks which resolved with Mycelet 1%. These blisters were pruritic and painful when broken with a clear discharge that stains clothing yellow. There was no bleeding when scratched or broken. Providers documented isolated erythemic papules with edema, TTP and 1-2 mm eczematous appearing vesicles with mild crusting/peeling of skin to feet and between toes. He reported resolution of torso, thigh, & forearm blisters within 2-3 weeks of onset being treated with Trimacinolone 0.1% ointment without reoccurrence; however various outbreaks continued along bilateral sides of fingers/toes, to webbing of hands/feet, and /or to palms/soles only. These blisters would last up to one month sometimes returning within a few days or it could be months between outbreaks. Lab/diagnostic studies included 2 negative KOH different sites (unknown sites) and a third as equivocal positive KOH (9/7/99), negative RPR and scables. Dermatology diagnosed hand eczema and ID reaction secondary to tinea pedis. Outbreaks occurred about 3-4 times a year (1999) until 2009 when he reported a decrease to 1-2 outbreaks per year. He did not remember any increase or if he had blisters prior to or after receipt of 11/29/1999 or 5/12/2000 AVA vaccinations. His last outbreaks were in August 2008  and then around June 2009 each lasting less than 1-2 weeks. He self treats with triamcinolone cream and "increasing protein in diet". Outbreaks occur any time if year. He denied any known triggers such as heat, cold, new clothing/socks, wearing gloves, new boots/shoes, soaps, deodorants, chemical exposure, insect/bug bites, prolonged wet feet (water/sweat).
Shot received on Wednesday. Chills that evening. Thursday and Friday experienced fatigue. Tuesday the injection shot started itching and it is red similar to a rash.
Red, itchy rash approximately 5 inches by 3 inches on left deltoid in the area of the vaccine injection.
hives on arms & legs (urticaria) 2/8hr psot vax & no resp involvement;referred to allergy clinic for testing;
Dizzy, slept 25 minutes after vaccine dose. BP 125/58, pulse 75. Stabilized - discharged to home.
Patient felt tightness across chest. Recovery nurse checked vitals and monitored for 30 minutes. Vitals checked again, WNL both times. Chest tightness dissipated and resolved, according to patient. Patient discharged to home.
Experienced swollen injection site that moved down to lower arm. Seems like fluid build up. Advised warm compress and BENADRYL. Follow up w/PCP if not improved after 1 day.
Information has been received from mother concerning her 17 year old daughter with allergic reaction to CECLOR and no pertinent medical history who in 2007 completed the series of the GARDASIL. Concomitant therapies were not reported. The mother reported that ever since her daughter finished the series, she has been having permanent problems with her menstrual cycle. The mother stated that her daughter has been in excruciating pain every time she gets her monthly period. The patient sought unspecified medical attention. At the time of the reporting, the outcome of the events were unknown. Additional information has been requested.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female with environmental allergies to pollen and mold who on 12-DEC-2007 was vaccinated 0.5mL, IM with a 1st dose of GARDASIL (lot# 659439/1267U). Concomitant therapy included PREVACID. It was reported that the patient had a positive urine pregnancy test (LMP 16-JAN-2008). The patient sought unspecified medical attention in her doctor's office. Follow-up information was received from the registered nurse to report that the patient went to another facility and had elective termination on 19-APR-2008. The patient's outcome was unknown. Upon internal review, elective termination was determined to be an other important medical event. Additional information is not expected.
Patient contacted pharmacy on 5/15/15 and stated he had 4-inch diameter warm, itchy rash at injection site. As of 5/21/15 symptoms have resolved.
Sore arm; Extreme body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Extreme body aches) 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 30-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Extreme body aches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Extreme body aches) outcome was unknown.            No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-369227 (Patient Link).
I would get the detailed vaccine information, but I am too tired to get my card. I have experienced severe fatigue.  I have been struggling with the onset of a manic episode due to Bipolar 1.  The fatigue due to the vaccine has exacerbated the problem and increased mania.  Had I known the extremely high prevalence of fatigue, I would have delayed vaccination.  I did consult with my psychiatrist prior to vaccination.  He did not seem aware of the high prevalence of fatigue.  If he did, he would have told me to delay vaccination.    Now I have mania problem that's getting worse.  A 25% incidence of fatigue needs to be disclosed for safety.    In addition, I am 37 years old.  I understand there is an age difference in adverse reactions.  COVID impacts 30 year-olds very differently than 50 year-olds.  However, the information available through the CDC reports data from 16-55 or something like that.  I need more detailed data.
Shoulder & arm to the elbow extremely sore; felt like torn muscle, limited range of motion.
Third shot in Guardasil series seems to have been injected too high.  Chronic shoulder pain experienced since.  For the first month or two, I could not sleep on that shoulder (side sleeping).  Lifting that arm above shoulder height hurt.   Side sleeping is now possible, but there's sharp pain on lifting my shoulder, throwing a snowball (I have a 6 and 3 yr old), and attempting to climb play structures at playground (kids again).  Other non-regular movements sometimes results in sharp pain.  Some days it's a low nagging pain I can usually ignore, but if I allow myself to focus I can notice it.
Headache, Myalgia, Arthralgia, SkinRash, Diarrhea, nose bleed, chills Narrative: headaches lasted 5 days localized itchy rash on left arm near vaccine site which lasted more than 2 weeks  chills, myalgia, arthralgia last 2-3 days diarrhea x 24 hours nosebleed was 1 episode the day after the vaccine
Varicella like rash appeared near L shoulder 2-3 days after receiving Zostavax on 11/18/07.  The rash is pruritic.
Myalgia, SkinRash, BURNING/TINGLING IN LEFT ARM, 2 QUARTER SIZE RASH SPOTS THAT SPREAD ND JOINED TOGETHER FORMING ONE LARGE RASH. Narrative:  EMPLOYEE SEEN AT URGENT CARE FOR RASH, BURNING/TINGLING OF LEFT ARM. DIAGNOSED WITH CELLULITIS & TREATED WITH BACTRIM BID. WAS SEEN TODAY BY PCP, SHE WAS ADVISED TO CONTINUE BACTRIM AND START TAKING BENDADRYL.
pt recvd vax @ 2PM on 20APR93; 2 hrs p/immun pt had no fever & sz; adm to hosp x 3 days for observation & tests; MD recommended ped DT for future vax;
This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a booster dose of 0.25mL instead of 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who was immunocompromised received a  booster dose of 0.25mL instead of a 3rd dose of 0.5mL/6 months gap between the 2nd dose and the booster dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHOTREXATE and PREDNISONE for an unknown indication.   On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received a booster dose of 0.25mL instead of 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who was immunocompromised received a  booster dose of 0.25mL instead of a 3rd dose of 0.5mL/6 months gap between the 2nd dose and the booster dose). On 13-Nov-2021, INCORRECT DOSE ADMINISTERED (Received a booster dose of 0.25mL instead of 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who was immunocompromised received a  booster dose of 0.25mL instead of a 3rd dose of 0.5mL/6 months gap between the 2nd dose and the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist stated that the patient signed up for the additional dose for immunocompromised people but got the half dose of 0.25mL instead of 0.5mLThe HCP asked, does the patient need a 2nd booster dose shot as they did not get a 3rd dose while being immunocompromised?  No Treatment information was provided
Rash covering upper right arm & shoulder within 24 hrs of administration.  Inflamed, itchy & bleeding rash.  Treatment: antibiotics, antihistamine & topical lotion for itch.
can't eat; patient woke in a pool of sweat that was so ubiquitous; extreme chills; massive kidney pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Apr2021 09:30 AM in left arm as single dose for covid-19 immunisation. Medical history included Seronegative RA and glomular nephritis. Patient not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 05:30 PM, 32 hours after the vaccine, patient could feel kidneys working overtime. He went into extreme chills and massive kidney pain, heat and clothes did not help. 38 hours after injection he couldn't stand the chill or the kidney pain so he took 800 mg ibuprofen and slept for 2 hours. 40 hours after injection patient woke in a pool of sweat that was so ubiquitous it went to the mattress. Since then (51 hours after injection) patient had bedridden with massive kidney pain. He can drink water but can't eat. Patient had not been tested for covid-19 since the vaccination. The events outcome was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.