chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 8 hours temperature 102.5 / Stayed around 102.1 to 102.7 for 24 hours / temperature around 100 for another 12 hours; extreme muscle aches; Body aches; angina; short of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 56 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF; "Cardiomyopathy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: nuts" (unspecified if ongoing); "stents" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Clindamycin, reaction: "known allergies: Clindamycin". 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: ANGINA PECTORIS (medically significant) with onset Sep2022, outcome "recovering", described as "angina"; DYSPNOEA (non-serious) with onset Sep2022, outcome "recovering", described as "short of breath"; PAIN (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "Within 8 hours temperature 102.5 / Stayed around 102.1 to 102.7 for 24 hours / temperature around 100 for another 12 hours"; MYALGIA (non-serious) with onset 22Sep2022 at 19:00, outcome "recovering", described as "extreme muscle aches". The patient underwent the following laboratory tests and procedures: Body temperature: (22Sep2022) 102.5, notes: Within 8 hours temperature 102.5; (Sep2022) 102.1, notes: Stayed around 102.1 to 102.7 for 24 hours; (Sep2022) 102.7, notes: Stayed around 102.1 to 102.7 for 24 hours; (Sep2022) 100, notes: Body aches and temperature around 100 for another 12 hours. Therapeutic measures were not taken as a result of angina pectoris, myalgia, dyspnoea. Therapeutic measures were taken as a result of pyrexia, pain. Clinical course: Within 8 hours, the patient had temperature 102.5, extreme muscle aches. Temperature stayed around 102.1 to 102.7 for 24 hours and tapered down slowly for another 12 hours. The patient had body aches and temperature around 100 for another 12 hours. This happened while she was taking 1000mg of acetaminophen. She did not go to the ER (Emergency Room), but she probably should had. Fourteen hours after, she was very short of breath and had angina. She had stents and CHF (Chronic heart failure). The patient did not receive vaccine in four weeks. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination.
approx 4PM 8MAR97 devel sx: t103-104 po, joint pain, muscle spasms, swollen lips-cherry red in color, & painful jaw;seen @ hosp & air evacuation to another hosp;
The next day, I experienced fatigue, SOB, nausea, SEVERE  muscle and joint pain, fatigue the following day for 36-48 hours.  for the weeks following, I experienced  SOB while exercising, fatigue, rapid heart rate and chest pain.  I did follow up with a cardiologist after learning of the cardiac inflammation associated with the event which were at the time normal.
Metallic taste in the mouth Right side shoulder extending to right arm pain Feeling of heaviness on the left side with jaw pain radiating to the left side of the neck Lymph node swelling in both sides of neck and under the left arm (Left arm lymph node swelling begin on 09/08/2021)
Within 24 hours of receipt of 2nd vaccine, emp noted itching to left arm around injection site, and red bumps described like "mosquitoe bites" to upper part of arm. Emp states she has used an OTC itching ointment which did help with the itching, but the bumps have not gone away.
I was diagnosis antiphospholipid syndrome, I was put on two different medications starting in February 07, 2023, and March 8, 2023. Two weeks after starting the medications I started having diarrhea, by week three I started having dizziness. I went into an urgent care when the dizziness became so severe, I could not walk. They sent me to the emergency, the emergency room performed an EKG, that came back negative. They gave me meclizine to help with the dizziness that did not seem to help as much as I would have liked. I have followed up with an ENT and Neurologist but they have not found what is causing the me to become so dizzy.
This spontaneous report as received from a nurse refers to a 13 year old male patient. In approximately February 2014 (reported as "about two months ago") the patient inadvertently received a fourth dose of GARDASIL (lot number and indication were not reported). Additional information is not expected.
Patient felt dreamy while walking out of office and fell backward striking head on floor, no loss of consciousness or neurological symptoms or focal problems on exam, no neck pain, did not know where he was for about 5 seconds. Was dizzy. Had not eaten before vaccination all day. Was given water, cool compress to forehead, crackers and allowed to sit for 30 minutes. All symptoms resolved.
The syringe leaked. When I questioned my arm being wet, the vaccinator stated not to be concerned that I got the vaccine.  My arms was slightly sore, which indicates that I did get vaccine into the muscle.  Clearly, I did not get 100% of the dose.  There were no adverse reactions or advents.  I don't know what other form to fill out.  I reported this to an administrator for the clinic and will take it up when I return for my second dose.
I had a fever over 100°/ my body was burning hot; terrible shaking and trembling; was freezing cold but; All over body aches; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (1st dose received on an unknown date, refer case US2020AMR055456).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, tremor, feeling cold, general body pain and headache. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the tremor and feeling cold were unknown and the outcome of the general body pain was not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the fever, tremor, feeling cold, general body pain and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient reported that she just received 2nd dose of Shingrix. The patient experienced fever over 100 degree F, terrible shaking and trembling within 10 hours of receiving vaccine. The patient was freezing cold but her husband said her body was burning hot.  All over body aches and headache. The fever had subsided somewhat, body aches continued, headache was better. The patient had enough with her first injection.Her husband did not experience this at all.      Lab Comments: On an unknown date, the lab test was perform
Arm warm, red, swollen all the way down the arm, itchy in spots.   Lasted 4 days.
Patient has raised red area at site of administration, states it hurts and itches, not sure of exactly what time it started, but sometime today 10/21/16.
Local reaction with redness (patchy) pain at site of vaccine and below (right upper arm).
Redness and erythema from the external arm down to the external elbow area, preceded by pain at the injection site for a first week.
Information has been received from a pharmacist referring to a 72 year old female patient. The patient had penicillin allergies. Medical history was reported as none. Concomitant therapies included VENTOLIN, SPIRIVA and FLOVENT. On 23-DEC-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # L034335 with expiration date of 18-MAY-2014, 0.5 ml, intramuscular). On 23-DEC-2015 a couple of hours after receiving the PNEUMOVAX 23, the patient's arm began to swell. The patient reported to the pharmacist that on 24-DEC-2015 her arm was red, sore, hot and swollen from the shoulder to the elbow, but that the symptoms were beginning to resolved (recovering). Pharmacist reported that he instructed the patient to ice the area and take BENADRYL. There was no lab diagnostics studies performed. Action taken with PNEUMOVAX 23 and causality of the events was not reported. Additional information has been requested.
This solicited report refers was received from a patient's relative, as part of a Market Research, and refers to a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose number, dosage, route of administration, lot number and expiry date not reported). On an unknown date, the patient had "serious" side effects from the vaccine (adverse event). The outcome of adverse event was unknown. The reporter considered the adverse event to be related to GARDASIL 9. Additional information has been requested.
Within 7 minutes heart rate increased to 98 -102.  Within 25 - 30 minutes experienced palpitations with HR 108. 1 1/2 hours post injection started to get strong headache and extreme nausea. 2 hours post injection extreme headache and nausea, seeing spots, difficult to look at computer screen, blurry. Palpitations resolved 3 hours post injection and HR started to come down. Unable to work so was sent home. Ibuprofen taken around the clock for extreme headache. Felt very fatigued. BP taken at 12 N 138/95, baseline that morning 118/78 HR 79. The next 2 days extreme muscle and joint pain. Continued to take Ibuprofen.
Patient states she is having soreness to her injection site and soreness up her arm, neck and into her left jaw.
Started coughing Monday; Seen @ ER on Friday 29NOV91 for "wheezing" t37.5; rx Ventolin syrup;
pt recv vax & 6hr post vax exp h/a;10 hr post vax pt exp severe vomiting & diarrhea;tx APAP suppository;all sx resolved w/in 24hr;
Within 5 to 10 minutes felt flushed, then a head rush. Got worse to the point where I was blacking out. Slumped in my chair grasping the sides holding on. Informed the person that gave injection that I might pass out, she said that I could sit there until I felt ready to go. Took deep yoga breaths while grasping on the chair hoping I would not pass out fall and crack my head. It slowly subsided. She kept saying I could go when I felt better. Really! I finally left after 30 minutes. Sat in my car with windows open for another half hour.  Felt better as the day went on, slept well and felt better the next day.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with VAQTA lot # N005274 and N012324 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002090: US-009507513-1708USA002736: US-009507513-1708USA002734: US-009507513-1708USA002737:
I was pretty sick. I had a headache, sinus pressure and body aches. I took Paxlovid and was ok for couple days and then everything came back, and I was pretty sick all over again. So, in total, I ended up being sick for about 2 weeks.
Developed red swollen area to left upper arm after receiving PREVNAR and Influenza vaccines in left deltoid. Slightly painful, no itchiness. 5x4 area slightly raised erythematous, bleachable on 10/12/16.
itchy rash on both arms/itchy rash chest and left neck area; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and rash (legs/left ankle). Previously administered products included Shingrix (received 1st dose few months ago summer of 2023). Concomitant products included ibuprofen (Advil), paracetamol (Tylenol) and cannabis (Medical Marijuana).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash on both arms/itchy rash chest and left neck area).The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.   It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-AUG-2023 The patient was with a history of shingles rash on legs and left ankle.  He states he received Shingrix (2 doses) a few months ago summer of 2023. He stated that a few months later he experienced an itchy rash on both arms, chest and left neck area.  He mentioned that he was taking Advil, Tylenol and medical marijuana.  No other information was provided. The reporter consented to follow up.
SEVERE vomiting & diarrhea 3-14 hours post vaccines. Temp of 103* 3-24 hours post vaccines. Vaccines included: MMR, Varicella, Flu
Headaches. Patient say he's had headaches for almost a year. (Since 01/15/21) Has gotten 2 other doses since then.
was fully vaccinated for herpes zoster in 2020/ suspected vaccination failure; herpes zoster; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included herpes zoster (had in the past, timed frame unknown). Concurrent medical conditions included eosinophilic asthma. Concomitant products included mepolizumab.   In 2020, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine and an unknown time after starting mepolizumab, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient was fully vaccinated for herpes zoster in 2020 and about 3 weeks prior to the report, the patient was presented to the emergency department and diagnosed with herpes zoster. The patient was on Mepolizumab 100 mg SQ every 4 weeks for severe eosinophilic asthma) when recently diagnosed in emergency department. The health care professional had not yet decided if Mepolizumab would be continued. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Fever (highest was 100.9), body aches, headache, blurry vision
Hot to touch pain L deltoid. H1N1 given at 1:40 pm & at 1:48 PM developed reddened rash & edema at injection site  (L Deltoid). Given BENADRYL 25mg P.O. No SOB. BP 148/28 - 140/20, & within 20-25 minutes rash dissipated in size. But did not resolve. Resolved after 24hrs with antibiotics/ steroids.
About 6 hours after injection, onset of headache, body ache, general overall lethargy. Then sleep interrupted by chills, and then sweats (so much so that  had to lay down a towel and another towel for my pillow). The next day was dominated by body aches and headache (I rarely get headaches). Loss of appetite.  This general condition of malaise lasted all day (the day after injection) and it was at times horrible. The symptoms  started to subside by the evening hours and I was able to have a better night sleep. By the next morning I felt better.
patient developed pain at the injection site (left upper deltoid) which worsened over the course of a week.  9 days later she is barely able to move her shoulder
Pt recvd Engerix-B 2 doses & following 1st dose 26MAR91 pt felt lousy; Following 2nd dose exp feeling "punk"; pt had routine physical on 16MAY91 which revealed elevated alkaline phosphatase & SGOT levels; Also sharp abdo pain; indigestion;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, dose number, lot number and route of administration were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
Narrative: COVID infection following COVID vaccine series 04/10 Janssen dose #1 CanO HEALTH (non-VA facility) 09/03 COVID swab, result: detected 09/03 pt cc: exposure: unknown
Severe cough, sore throat lasting for > 7 days starting on 10/22/2018. No fever, no aches or pains other than cough related soreness in ribs and diaphragm. Treatment: cough medicine and rest
mom reports inc temp 103 very seldom would to down w/APAP;constant cry close to 3hrs, knot on rt leg w/rash;did apply cold to leg;
Redness on injection arm; Hardness about the size of a quarter at the injection site; Pain in injection arm; Feverish skin near injection site; Limit mobility in injection arm due to pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on injection arm), VACCINATION SITE INDURATION (Hardness about the size of a quarter at the injection site), VACCINATION SITE PAIN (Pain in injection arm), VACCINATION SITE WARMTH (Feverish skin near injection site) and VACCINATION SITE DISCOMFORT (Limit mobility in injection arm due to pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on injection arm), VACCINATION SITE INDURATION (Hardness about the size of a quarter at the injection site), VACCINATION SITE PAIN (Pain in injection arm), VACCINATION SITE WARMTH (Feverish skin near injection site) and VACCINATION SITE DISCOMFORT (Limit mobility in injection arm due to pain). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on injection arm), VACCINATION SITE INDURATION (Hardness about the size of a quarter at the injection site), VACCINATION SITE PAIN (Pain in injection arm), VACCINATION SITE WARMTH (Feverish skin near injection site) and VACCINATION SITE DISCOMFORT (Limit mobility in injection arm due to pain) outcome was unknown.            Concomitant medications were provided was Unknown, lost in crash. Treatment medication were not provided.
1 WEEK AFTER GETTING 2ND COVID-19 MRNA PFIZER VACCINATION, PATIENT HAS HAD 3 SUBSEQUENT ALLERGIC REACTIONS TO EATING CASHEWS AND NOW PISTACHIOS.
Sore arm, headache x 2 days. Severe myalgias and Rhabdomyolysis developed after 5-6 days.  Briefly, 30 yo gentleman h/o bipolar disorder, opioid use disrder (on methadone), nicotine use disorder (vaping), recent Janssen COVID vaccination (about 1 week ago) who was admitted with a few hours of myalgias and dark urine, notable recent moderate exercise and over-ingestion of gabapentin. For Rhabdomyolysis: 4/16/2021: CPK peak 95,694; AST peak 779, ALT peak 282, Cr 1.0, Plt 279 Treated with aggressive IV hydration with improvement.
Pt. C/O hot flash and dizziness at the time of vaccination then 2 minutes later she developed a migraine headache at 4:37. She had difficulty walking from her chair to the medical cot due to pain but responded to taking a dose of her own medication of 400mg of  Advil and also placing cold packs no her forehead and neck. The pain gradually eased and she was able to leave the clinic at 17:06 feeling better.
I forgot to reconstitute the lyophilized shingrix vaccine component.  I drew out the adjuvant, portion.  I mistakenly thought, I had already reconstituted it. I switched to the safety needle.  I adminstered it to the left deltoid IM.  After the patient left, I recognized I had failed to reconstitute the vaccine because it was still in the vial.  I called the patient to report the error.  I called the manufacturer for step by step instructions on how to remedy the error.  They were closed.  I informed the patient I will call them on Monday.  Patient was experiencing no adverse effects of incomplete vaccination.
SORE VEIN NEAR LEFT COLLER BONE; COLLAR BONE AREA SWOLLEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient experienced sore vein near left coller bone. On 14-APR-2021, the patient experienced collar bone area swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore vein near left coller bone and collar bone area swollen was not reported. This report was non-serious.
The patient began to run a fever of 102.9 approximately 12 hours after the injection. The patient developed a red spot, that was warm, sore and swollen.
Patient developed parosmia approximately 2 weeks after first COVID vaccine. Foods taste like "poop", now noting metallic taste to certain foods. Has persisted beyond 2nd Pfizer COVID vaccine administered 5/6/2021. As of 5/26/2021, symptoms have improved but not resolved
p/vax pt arm swelled up from shoulder to elbow (inj site); condition of pt unknown