chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax for prophylaxis; 1 wk later exp pain in knees & legs,redness at inject site; sxs resolved;
Red rashes on the injected arm starting 7 days after the vaccination. Symptoms include itchiness and redness.
Shingles. Varivax given in 1997; no history of "wild chickenpox".
This spontaneous report as received from a physician assistant via company representative refers to a 63 year old female patient. On 17-JUL-2015 the patient was vaccinated with ZOSTAVAX vial (lot # L011534 and expiry date not reported) of dose 0.65 milliliter (ml) once, subcutaneous to prevent shingles. Concomitant therapies included unspecified thyroid medication, TOPIRAMATE, FOSAMAX and probiotics. On 18-JUL-2015, the patient developed rash with "macular lesions that wrapped around her lower left extremity, it was itchy, warm to the touch, red and burning". On the same day of 18-JUL-2015, the physician assistant instructed the patient to put hydrocortisone cream (manufacturer unspecified) on the rash as treatment however "it made the rash worse" (captured in MARRS # 1508USA011725). The patient sought for the medical attention and was then seen again by the physician assistant on 21-JUL-2015 and she was prescribed Acyclovir (manufacturer unspecified) and Betamethasone cream (manufacturer unspecified) as treatment. No laboratory details were provided. The outcome of rash with macular lesions that wrapped around her lower left extremity, itchy, warm to the touch, red and burning was unknown. The causality of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the two reports of the same patient. Additional information has been requested.
Patient received flu vaccine and shingles vaccine on 10/6/14. Patient reporting chills, fever, aching and nausea from 10/13/14 - 10/15/14.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 2, single (Lot number: LC3184) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Previous dose details , product=COVID 19,, brand=Pfizer,, brand unknown=False,, lot number=LC3181,, lot unknown=False,, dose number=1,, vaccine location=Left arm), administration date: 10Aug2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (medically significant) with onset Oct2021, outcome "not recovered", described as "Acute Tinnitus in both ears diagnosed in Apr2022 after months of suffering". The event "acute tinnitus in both ears diagnosed in Apr2022 after months of suffering" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (Sep2021) Negative; (Sep2021) Negative; (Dec2021) Negative; (Dec2021) Negative. Therapeutic measures were not taken as a result of tinnitus. Clinical Information: It was reported that patient received no other vaccine in four weeks and patient received other medications in two weeks. No other known allergies. Adverse event start time was provided as 08:00 AM.
Extreme tiredness starting 10am 5-7 lasting until Saturday 9am. Chills starting 12pm 5-7 lasting until 5am Saturday 5-8. Low grade fever  12pm 5-7 until 5am Saturday 5-8. Arm pain swelling and redness at injection site 7pm 5-7 ongoing.   I had Covid  with moderate symptoms April 2020
This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on an unspecified date (at the age of 38 years-old) as dose 2, single for covid-19 immunization. Patient medical history was not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No other vaccine in four weeks. Concomitant medications included echinacea (ECHINACEA) and multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on an 23Apr2021 at 10:00 (at the age of 38 years-old) as dose 1, single for COVID-19 immunization and reported that the injected arm was very sore to lift above shoulder level. On 15May2021 at 01:00, the patient reported that the injected arm was sore again, but not as bad. Possibly due to moving the arm more to prevent it from being sore, she had 102 temperature about 12 plus hours after the shot, accompanied with a headache and 24 hours after, she had about 100 temperature and 2 days later she felt better. The patient underwent lab tests and procedures which included body temperature: 102 degree (degree, about 12 plus hours after the shot) and body temperature: 100 degree (after 24 hours) on an unspecified date. Therapeutic measures were taken, and patient took 2 Advil to relieve the pain and it helped. The clinical outcome of all the events was resolved on an unspecified date in May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Profound fatigue.  Extreme body aches. Skin hypersensitive. Touching hair was highly irritating.  Blood oxygen second day Tuesday = 86.6.
upraised welts three days after shot in the same spot as injection site. no pain. just thought i should report it for data purposes
Onset-same day c/o progressive (R) upper arm pain with associated dizziness, fatigue, chills, low grade fever --> nausea, diarrhea, vertigo, and increased swelling (R) arm (+) axillary & cervical lymphadenopathy @ day 6 after vaccine.
From nurse perspective, was administering vaccine to nervous patient and when she administered shot, needle was faulty and she states potentially only half of the dose may have been injected. She stated that she explained to father and said we might need to inject half of the dose again. Before she could even try, patient was leaning forward and fainted to the ground and fell flat on her face. Pharmacist (me) was called a little bit after the fall and explained the situation. We grabbed ice and placed a bandaid on forehead and suggested to parent she was probably okay, but was up to him whether he wanted EMS.  Father refused second dose bc patient was agitated.  Father was frustrated at lack of first aid care and choose to leave after waiting about 15 minutes from vaccination.
Large red, raised itchy rash at injection. Rash appeared approximately eight days after getting injection.
Extremely high eosinophil counts for over 1 month; Elevated white blood count; Extreme upper abdomen bloating; Pain; Nausea; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231, expiration date: 30Apr2021 ) via an unspecified route of administration in the right arm on 30Dec2020 at 07:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, asthma, high-density lipoprotein (HDL) and vitamin deficiency. The patient had allergy to medications, food, or other products which are not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking concomitant medications within 2 weeks of vaccination which are not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 the patient experienced extremely high eosinophil counts for over 1-month, elevated white blood count, extreme upper abdomen bloating, pain, nausea and extreme fatigue with a trip to urgent care and Emergency room and with multiple Dr's, testing, imagine, and specialists, no one was able to figure out what was wrong with her. Therapeutic measures were taken as a result of the events with different medications (name not specified), tests, imaging and specialists; (unspecified) . The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely high eosinophil counts, elevated white blood count, extreme upper abdomen bloating, pain, nausea and extreme fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
ZOSTAVAX given subcutaneously in right upper arm 10/31/12. Pt was seen today with pain, swelling (approx 8 cm in diameter) and erythema. Physician notified - pt was told to take ibuprofen and ice areas as needed.
More fatigue than usual.; This is a spontaneous report from a contactable consumer, the patient.  A 75-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, hypertension and vertigo. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN), terazosin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN) and ulinastatin (STATIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, the patient experienced more fatigue than usual. No therapeutic measures were taken as a result of the events. The clinical outcome of the event more fatigue than usual was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
7 days post vaccination (a Sunday) I felt achey, tired, toxic. I went to bed for a couple of hours. That night intense muscular and joint aches woke me from sleep. I got up, took 2 Ibuprofen and was able to fall back to sleep.  The next morning, Monday, I was 90% better and by the following day, Tuesday, completely fine. However, I realised it was a reaction to the shot and not an isolated incident when I emerged from a hot shower Tuesday  and found a huge bright red blotch covering the entire top of my left arm, around the injection site. The arm was not sore, but it looked seriously inflamed. Note: I did have an initial  reaction to the shot; the standard sore arm and body aches for 24 hours right after the injection. The reaction I had a week later was similar but much stronger.
A couple of days after the vaccine I started experiencing warmness and a "tickle/numb" feeling on the left side of my face (this happened w/ the first and second vaccine). As time progressed, began feeling increased pain in my neck and shoulder, within a few weeks the pain had traveled down the entire left side of my body and was starting to affect normal activities.  Started experiencing excruciating pain in my lower back and left leg. Also some minor pain in lower left abdomen Numbness and weakness in left limbs with pin and needle feeling in arm/leg/hand and foot on the left side. Started dropping things when holding on my left side. Started also having odd sensations in my brain like brain zaps. Where I start feeling warm in my face and then lose focus, have to concentrate really hard to process information and my eyes began to try to focus again.  Left foot has random itching spells, which are worse at night, and have noticed that I can not empty fully empty bladder like before or feel the sensation of when I have to go until it is full.  Have also experienced an elevation in BP/HR with some chest pain and shortness of breath.
I started to affect all my body parts. My feet, my hands, my knees, etc. I couldn't do normal things. It hurt and it felt like needles in my hands and feet. I also got a couple of bumps on my heels, and my hands and forearms. I am on prednisone to help the symptoms. The bone on my right wrist got huge. I had to go back to one day a week at work. I got diagnosed with rheumatoid arthritis. I am also on methotrexate and folic acid. These are the medications that the doctor has me on. They want me to be on Humira as well. I am unable to open bottles or I can not even squeeze bottle as well.
Patient & parent state when she woke on 12/29/07 arms & legs felt "stiff" & "hurt".  Difficulty walking lasted through the day.  Resolved spontaneously by evening.  Not seen by physician.
extreme soreness; minor swelling; stiffness; It's debilitating my ability to earn money and pay bills; Bilateral pain in arms; Numbness in both arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme soreness), SWELLING (minor swelling), MUSCULOSKELETAL STIFFNESS (stiffness), ASTHENIA (It's debilitating my ability to earn money and pay bills) and PAIN IN EXTREMITY (Bilateral pain in arms) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Bilateral pain in arms) and HYPOAESTHESIA (Numbness in both arms). On an unknown date, the patient experienced PAIN (extreme soreness), SWELLING (minor swelling), MUSCULOSKELETAL STIFFNESS (stiffness) and ASTHENIA (It's debilitating my ability to earn money and pay bills). At the time of the report, PAIN (extreme soreness), SWELLING (minor swelling), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (Bilateral pain in arms) and HYPOAESTHESIA (Numbness in both arms) had not resolved and ASTHENIA (It's debilitating my ability to earn money and pay bills) outcome was unknown.        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.   Concomitant medication also included other vitamins. No treatment medications were reported.  She was having an electrogram and nerve procedure done this week. Patient saw physician in April for severe pain and numbness.   This case was linked to MOD-2021-237947 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow up received on 06-AUG-2021.  added Containing Event added (Debility, pain in arms and Numbness of upper arms)
Pt reportedly received 2nd dose of Pfizer and shortly after reported diffuse itching, rash, nausea. Pt received IM epinephrine, pepcid, prednisone and Benadryl. She had improvement of symptoms after treatment and received additional dose of hydroxyzine for residual itching.
pt recvd vax & had sz; became stiffened & a tremor; eyes rolled up & discoloration; breathing ok; pt was foaming at the mouth during sz; t 104; pt is teething w/ some runny nose;
15 min after ist YF vaccine SOB, wheeze, eyes swelled shut, itchy red rash all over. Seen in Medical Department Rx epinephrine and Benadryl. Had also gotten PCN, OPV, Td, Hep A.
esophagus is severely inflamed; unable to eat or hold down fluids; nausea; vomiting (thick mucusy stomach fluid); Fluid at bottom of lungs; Acites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed), FEEDING DISORDER (unable to eat or hold down fluids), NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced PLEURAL EFFUSION (Fluid at bottom of lungs) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting (thick mucusy stomach fluid)) (seriousness criterion hospitalization). On 21-Mar-2021, the patient experienced OESOPHAGITIS (esophagus is severely inflamed) (seriousness criterion hospitalization) and FEEDING DISORDER (unable to eat or hold down fluids) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to FEEDING DISORDER, NAUSEA, OESOPHAGITIS, PLEURAL EFFUSION and VOMITING. At the time of the report, PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed) and FEEDING DISORDER (unable to eat or hold down fluids) had not resolved and NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) blood work done shortly before getting COVID vaccine and everything came back normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional information: Patient was admitted to the hospital 10 days ago on 21Mar2021. Nausea and vomiting was continuing, patient's esophagus is severely inflamed, patient is unable to eat or hold down fluids, had to start TPN, has had Gastro-Intestinal biopsies performed, Computed Axial Tomography scans, endoscopy, esophagram, oncologist consulted-nothing showing up, fluid in bottom of lungs, ascites-pulling fluid off abdominal cavity with paracentesis (first on 5Mar2021, second paracentesis scheduled for today.) Doctors have been in touch with another facility.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The pt has an 8 cm are of erythema and induration to the right mid thigh. Treated with ice, heat, and Motrin.
Experienced severe inspiratory and expiratory wheezing, difficulty breathing, sore throat and hoarseness. Went to the emergency dept., vitals were stable, no fever, received breathing treatment, prednisone and Zithromax PO and was discharged with scrips for both meds. to continue. Then the early hours of Monday 11/8/09 same events but worse than previous, arrived at the same ED at 03:00 am . HR in the 150's, bp 169/92, no fever. Over the course of 4 hours received 3 breathing treatment and Solu-Medrol IV. Chest X-Ray was taken; no abnormalities noted. Discharged home, instructions to continue meds. and use Albuterol inhaler q4h. Folow up with primary care physician.
Patient presented with hives /itchiness and redness on arms ,legs and body  Patient received Hydrocortisone cream 1% Symptoms resolved and was localized  checked on patient after an hour and she confirmed that no further symptoms
Extreme Fatigue - I wasn't well; I couldn't do my normal activities; my neck bothered me and caused headaches. I have also experienced dizziness and a little nausea - it's an equilibrium thing as if I've been drinking. It gets kind of scary, like I'm going to drop. Because of the Cushings, I have, it may be causing my body to deal with more than I can. Worse of it 04:00 am last Monday - my headache was so bad I had to stand up. Any pressure on the neck exacerbates my headache. At 04:00 am I couldn't take it right away but a little later it was 101.7 degree fever -it would climb and break and for three days (had chills with it); and then it seemed like I was having Menopausal hot flashes where I don't feel feverish but just break out in a sweat. I'm doing that right now. (The worst days were up to the first 72 hours after 04:00 am). I am going to see an Orthopedic surgeon for necks (in case my symptoms are not from the vaccine) on October 5 (postponed to this because I have a fever) - this is for my neck and head. The headaches get scary - it seems like they get so bad. I had two years ago - a brain tumor removed - that's what Cushing can do. They removed it successfully - the endocrine system try to recover and the adrenals are fighting (so the dizziness and the faint is what might be happening in response to that).  The headache and the neck - these symptoms have me highly suspicious. Last night, it was scary, it's as if I'm walking on a boat, like I've been drinking, my balance got so off and I got nauseous and my head is killing me and my bowels are loose and make me feel kind of sick on Thursday - and got Tested.
Pt received 3 series of 3 Engerix B vaxs. serology noted failure to respond
Period seemed to stop immediately (3days instead of typical 4-5 days); Hormonal warning symptoms that period is coming, changes notice in body right before period comes; Swollen tender breasts; Swollen tender breasts; Back pain; Feel like crying easily without provocation-completely connected to hormones; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24May2021, the patient had period seemed to stop immediately (3days instead of typical 4-5 days), hormonal warning symptoms that period was coming, changes noticed in body right before period comes, swollen breasts, tender breasts, back pain and feel like crying easily without provocation-completely connected to hormones. It was reported that the period had not started again yet. Thankfully, it just felt like it was about to. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of period seemed to stop immediately (3days instead of typical 4-5 days), hormonal warning symptoms that period is coming, changes notice in body right before period comes, swollen breasts, tender breasts, back pain and feel like crying easily without provocation-completely connected to hormones was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.