chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy left arm). On 02-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red ball). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 f (High) fever (100.8F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided.
Hives; Rash; Chills; Fatigue; Itchy tongue; Itchy lips; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medication included metformin 1000 mg/day from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 20:00, the patient experienced hives, rash, chills, fatigue, itchy tongue and lips. The patient was treated for the hives, rash, chills, fatigue, itchy tongue and lips with BENADRYL. The adverse events resulted in a visit to doctors or other healthcare professional office/clinic visit. The clinical outcome of the hives, rash, chills, fatigue, itchy tongue and lips was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
She reported pain at the injection site the evening the shot was given, then within 24 hours of receiving it the injection site became a large red area warm to the touch. It took 4 days for the heat to go away and 7 days for the redness to go away. I informed her to visit a physician if she continued having this reaction 2 days after receiving the shot. She waited it out instead and reaction cleared on its own. She does not have internet access so I am submitting this on her behalf.
Pt developed an oval, erythemic area of 4.5" on left lateral leg at injection site that was slightly sensitive to touch. 2-3 cm of the inside of the oval had a section of induration.
Pain and weakness in arm, impedes activities of daily living. Constant ache at injection site and shooting pain from that location with movement.
Fainted 48 hours after shot, sweats, slumped over. Luckily I was there to catch her. Complete loss of color. Came on very suddenly. Could have been catastrophic if she was driving.
Pt has developed severe limitation in large joints, shoulders and hips within 3 weeks of doses. Pt previously was avid swimmer, swimming  five or more days a week
Severe Dizziness and stroke like symptoms.  Rest, time, and vestibular physical therapy helped a lot.
13 hrs post injection developed body aches, then chills, fever reached 101.8f orally, headache, hurt head to look around the room, extreme exhaustion and nausea- symptoms lasted a total of 36 hours post injection
First two days I had a sore arm with sharp nerve pain down the bottom of my forearm into my pinky finger and ring finger. The next day it felt tight and painful. Since then, it's more muscular feeling and was prescribed a 5 day regimen of steroids to help with potential inflammation. I've now completed that and still feel a weird sensation down the top of my forearm into my pinky.
4 y/o female with H/O low grade fever and right arm swelling/erythema. Swelling and erythema extending to mid-arm. Significant pain. Symptoms began within 10 hours of receiving vaccines.
This spontaneous report as received from a Registered Nurse refers to a 15 year old male patient. On 20-AUG-2013, the patient was vaccinated with first dose of GARDASIL, on 05-SEP-2013, the patient was vaccinated with second dose of GARDASIL and on 08-OCT-2013, third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
SHE HAD A HORRIBLE SCREAM THAT LASTED FOR AROUND 3 HOURS.SHE WOKE UP SCREAMING LIKE THIS.SHE WAS ALSO STIFF AND THROWING HERSELF BACK AND FORWARDS.AND THEN SHE JUST PASSED OUT AND SLEPT FOR 2 HOURS.SHE RAN A FEVER OF 101 FOR TWO DAYS.NOONE TOOK ME SERIOUSLY AND THE DOCTOR KEEPS TRYING TO PUSH ANOTHER ONE.I WAS TREATED AS AN IDIOT AND BULLIED NEVER ONCE HAS ANYONE EXPLAINED TO ME WHAT HAPPENED OR OFFERED ANY SORT OF CHECK UP TO MAKE SURE SHE IS OKAY.
Lost all recollection of time and memory for 12 hours.   Body heat to severe sweating.
102.3 fever, elevated heart rate & blood pressure.  Fever did not go down with aspirin and tylenol for 1 day. Shot  location swollen, red and hot - about size of tennis ball. Super lethargic, tired had to sleep, chills, & sweats. Body smelled of ammonia (not of urine).     Symptoms lasted for 1.5 days, but arm is still hot, red and swollen.
administered Menactra on 31Jul2019 in error; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15-month old female patient who was vaccinated with a second booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6152AA (expiry date: 19-Mar-2020) via unknown route in unknown administration site on 31-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to extra dose administered. It was reported that patient received second booster of Menactra after she received the it in a year prior.  It was not known whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
GOT THE SHOTS AND STILL GOT COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got the shots and still got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got the shots and still got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000216213. The suspected product quality complaint has been confirmed to be the reported event is not associated with a product defect or product performance issue. this customer preference case has been assessed and does not represent a product quality complaint. the disposition/root cause determination was documented properly and the product record closed. based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 08-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
3/26/21 Vertigo with nausea and epigastric pain , went to local ER.  9/24/21 Vertigo with nausea and epigastric pain, after calling insurance nurse line, was advised to go to ER. 09/30/21 Follow up with physician at local Health Center, referral for physical therapy.  10/01/21 Physical therapy, which resulted in a positive test for benign paroxysmal positional vertigo.
Hives first on flanges top hands & metaltarsels Lower back sacrum and full gluteal fever itchy all over body hives later on elbows and knees
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was intramuscularly vaccinated with 0.5 ml GARDASIL (Lot #665547/1318Y, Exp date 12-JUN-2012, dose number unspecified) on 14-AUG-2012. The healthcare worker called to reported that the patient was administered GARDASIL that expired 12-JUN-2012, and it was give 14-AUG-2012. No adverse effects reported. It was unspecified whether the patient had sought medical attention or not. The outcome was unknown. Additional information has been requested.
Large red round spot at injection site up to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Large red round spot at injection site up to elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large red round spot at injection site up to elbow). On 27-Jan-2021, VACCINATION SITE ERYTHEMA (Large red round spot at injection site up to elbow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
blood clots on both lungs; I was playing tennis and could not breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "blood clots on both lungs"; DYSPNOEA (non-serious), outcome "unknown", described as "I was playing tennis and could not breathe". The event "blood clots on both lungs" required emergency room visit. The events "i was playing tennis and could not breathe" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: blood clots on both lungs, notes: They did a ct scan and said I had blood clots on both lungs.  Clinical course: Patient reported "I am a 78 year old woman who played tennis twice a week and was in excellent physical condition. At the end of Mar2023 I was playing tennis and could not breathe. I drove to my doctors office and he said needed the emergency room as I might be having a heart attack. They did a CT scan and said I had blood clots on both lungs. It was a serious but I managed to live. The only thing I could attribute it to was that I had that latest Pfizer booster on 06Jan.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown.  No follow-up activities are needed. No further information is expected.
One week after shot, injection sight started itching about 8 am  with slightly raised red rash about size of 50 cent  piece.  Warmer than surrounding area, not sore. Probably should have waited till it stopped itching to file report but almost done with this report.
flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced flu-like symptoms. The reporter stated that, the patient experienced adverse event months ago (exact date unknown) and he also reported the adverse event already to GlaxoSmithKline months ago. No further information reported.
Pt was reportedly in very good health prior to vaccination". Concurrent conditions, and concurrent medications were not provided. reportedly the pt rec'd her 1st injection of hepatitis B vaccine in 1993 pr 194. the pt's mother reported that 10 minutes after receiving the injection the pt experienced swelling at the injection site. The swelling resolved after an unspecified period of time. She then reportedly experienced headaches for the next 4 days. The pt then experienced "joint pain in arms and legs that progressed over the next couple of years". She also reportedly experienced depression and blurred vision. The pt's mother reported that a diagnosis of fibromyalgia was made. The hepatitis B immunization series was discontinued. As of 4/30/02, the injection site swelling and headaches had resolved. The outcome of the fibromyalgia was not specified.
Pt complains of Dizziness, fatigue, and rash starting 12/3/08.
Seated. Injection by medical assistant - (R) deltoid. Min pain. Turned head to look at injection site. Some bleeding - rapidly light-headed - fainted. Brief - Then vomiting. Allowed to rest supine. Then sitting. Then standing without problem.
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin.  Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO).  After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry.  At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not  diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No).   Follow-up attempts are completed. No further information is expected.
Patient called after hours 10/30/17 to report an injection reaction in her right arm where PPSV23 was administered earlier that day. Patient followed up in the office with a visit on 10/31/17. According to notes the reaction area is red, warm and tender to the touch. According to the PA who saw patient 10/31/17 the reaction area starts 2 cm below the injection site and extends 13 cm towards the elbow and extends from the bicep to mid tricep. PA recommended symptomatic treatment during our discussion, however, the office visit note is not finished.
Woke up with bad pain in right arm, pain all over body, very weak, head hurting, no appatite, swelling right shoulder, redness expanding around shoulder.
First 2 days achy arm, itchy then OK.  On 2-9-2021 schedule to donate blood.  Went in for regular check but pluse rate was 110.  After 20 minutes, when it did not subside was turned away from donating.  had bee a bit short of breath so after 2 more days went to provider.  heart rate still high, B normal.  Chest xray was ordered and report was hyper extended lungs, COPD.  Having never somked in my life baffled.  Had Pulmonary function was rated normal but noted lungs age of 82 year old.
Less than 24 hrs later, left arm pain, left arm numbness/tingling, left side of face numbness/tingling, left side of head numbness/tingling, left side of neck numbness/tingling, left arm pit swelling, left arm swelling, fatigue, headache for 2 weeks.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This was linked with Case ID 2018SA286240, 2018SA286241, 2018SA286245, 2018SA286243, 2018SA286244 and 2018SA286233. This case involves Adult female patient who experienced significant local redness and swelling that warm to the touch, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 09-Oct-2018, the patient received a dose of suspect Influenza Quadrival A-B Vaccine (frequency once), lot U1982AA via unknown route in unknown anatomical site. On 12-Oct-2018, 48-hours post vaccination the patient developed a non-serious significant local redness and swelling that warm to the touch (vaccination site inflammation) following the administration of Influenza Quadrival A-B Vaccine. (Other relevant tests included no lab data.) Final diagnosis was significant local redness and swelling that warm to the touch. No corrective treatment was received. The event outcome was reported as Unknown. List of documents held by sender: none.
fever of 101 degrees F and body aches. Fully resolved within 24 hours.
4/18/21 Awoke: headache, chills, sore arm (present for several days.) New symptom: nausea and vomiting, rapid abnormal heartrate.
Very bad headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6204), dose 1 via an unspecified route of administration on 05Mar2021 (at the age of 69-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Mar2021 04:00, the patient suffered with very bad headache. On an unknown date of Mar2021, patient had chills. Therapeutic measures were taken as a result of very bad headache and chills with Ibuprofen as suggested. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
6 days after getting the first Covid shot, I had heart palpitations.  I went to the primary care doctor and he did an EKG and everything seemed normal but he advised if it happened again that I go see a cardiologist.  Then, on May 17 I developed a cough that produces a lot of phlegm and it has lasted about a month.  It feels like air trapped in my lungs that I just can't cough out.  It's a very annoying feeling. I still have it till this day, but now I get swollen ankles, especially on the right foot.  The swelling comes and goes.  I recently moved to a different state and had to find a primary care doctor.  I have an appointment on Wednesday, June 23 that I registered for online and just waiting for the doctor's office to confirm the appointment.
Right leg pain, blistering rash, nausea, dizziness, administering antiviral shingle medication.
had menstrual cycle for 10+ days after getting shot. haven?t had  period in months prior to this