chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the first dose, she had a little soreness in her shoulder; felt like her chest was a little different; sleepy; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Lot number: EW0175) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Diagnosed years ago, has had since 2004 or 2005.; "Arthritis" (ongoing), notes: Diagnosed in 2018 or 2019; "Diabetes", start date: 2018 (ongoing), notes: Borderline in 2018, but started taking medication this year in 2021.; "immune system was weak" (unspecified if ongoing); "Swelling" (unspecified if ongoing); "Nerve pain in her joints" (unspecified if ongoing); "Mild pain" (unspecified if ongoing). Family history included: "Asthma" (unspecified if ongoing), notes: Grandmother had asthma. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); LOSARTAN taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); VITAMIN D [VITAMIN D NOS] taken for vitamin supplementation (ongoing); FOLIC ACID (ongoing); METHOTREXATE taken for arthritis (ongoing); GABAPENTIN taken for arthritis, neuralgia (ongoing); FUROSEMIDE taken for swelling (ongoing); CELEBREX taken for pain (ongoing). The following information was reported: ARTHRALGIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "the first dose, she had a little soreness in her shoulder"; CHEST DISCOMFORT (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "felt like her chest was a little different"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "unknown", described as "sleepy"; FATIGUE (non-serious) with onset Aug2021, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
massage it and move her arm; itchiness and her arm swelled up; did not feel hungry; heart was feeling funny, it dint feel quite right; hard time getting up off the sofa and to walk; hip, shoulder, elbows, neck and back hurt; hip, shoulder, elbows, neck and back hurt; gets all stiff and can hardly move; hands are big from the arthritis and make her drop stuff; arm became sore; itchiness and her arm swelled up; hip, shoulder, elbows, neck and back hurt; tired; headache; This spontaneous case was reported by a patient and describes the occurrence of JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right) and MOBILITY DECREASED (hard time getting up off the sofa and to walk) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gallbladder disease, Diabetes, Emphysema and Allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right), MOBILITY DECREASED (hard time getting up off the sofa and to walk), BACK PAIN (hip, shoulder, elbows, neck and back hurt), NECK PAIN (hip, shoulder, elbows, neck and back hurt), MUSCULOSKELETAL STIFFNESS (gets all stiff and can hardly move), ARTHRITIS (hands are big from the arthritis and make her drop stuff), PAIN IN EXTREMITY (arm became sore), PRURITUS (itchiness and her arm swelled up), ARTHRALGIA (hip, shoulder, elbows, neck and back hurt), FATIGUE (tired) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right), MOBILITY DECREASED (hard time getting up off the sofa and to walk), BACK PAIN (hip, shoulder, elbows, neck and back hurt), NECK PAIN (hip, shoulder, elbows, neck and back hurt), MUSCULOSKELETAL STIFFNESS (gets all stiff and can hardly move), ARTHRITIS (hands are big from the arthritis and make her drop stuff), PAIN IN EXTREMITY (arm became sore), PRURITUS (itchiness and her arm swelled up), ARTHRALGIA (hip, shoulder, elbows, neck and back hurt), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included 4 different blood pressure medications
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever; muscle aches; Nausea; Diarrhea; headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN6198), via unspecified route of administration in the left arm on 26Feb2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history includes Rheumatoid Arthritis(was on immunosuppressant medications past 3 years) and allergies to Penicillin and Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. Past drug history include allergies to BACTRIM, ENBREL and HUMIRA. The patients concomitant medications include XELJANZ XR from unknown dates for unknown indication and concomitant therapy include Immunosuppressant medications since past 3 years for Rheumatoid Arthritis. On 26Feb2021 at 16:00, on the same day of vaccination, the patient experienced Fever, Muscle aches, Nausea, Diarrhea and Headache close to a full week following vaccine. The Clinical outcome of the Fever, Muscle aches, Nausea, Diarrhea and Headache were recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.
I had numbness on my legs; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 10Mar2021 as dose 2, single for covid-19 immunization. The patients medical history included multiple sclerosis (MS) from Nov2020 (diagnosed last November with primary progressive MS). The patients concomitant medications were not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 17Feb2021 as single dose for Covid-19 immunization. On an unspecified date in Mar2021, patient had numbness on his legs after second shot and was just lasted for one day. He had blood test on 14Apr2021 doctor sent an email stated that patient did not develop antibodies to the COVID vaccine. The patient underwent lab tests and procedures which included blood test: antibodies not developed on 14Apr2021 to the COVID vaccine. The outcome of event was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient states got shingles about 2 weeks after vaccination.  she also had the same thing happen after her 2nd dose of moderna (not administered at our pharmacy)
Initial misuse report received from a healthcare professional on 01 MAY 2013. It was reported that the patient who had received first dose of ADACEL on 15 DECEMBER 2006, received second dose on 01 MAY 2013. No adverse event was reported. Documents held by sender: none
HUNGRY ALL THE TIME; STEROIDS MADE UNABLE TO SLEEP; HEAD COLD; HEADACHE; FULL BLOWN COLITIS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ulcerative colitis. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) colitis was 7300. On JUN-2021, Laboratory data included: Blood test (NR: not provided) colitis was 41. On AUG-2021, Laboratory data included: Blood test (NR: not provided) colitis was 4500. On 16-AUG-2021, the patient experienced full blown colitis. On an unspecified date, the patient experienced hungry all the time, steroids made unable to sleep, head cold, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the full blown colitis, hungry all the time, steroids made unable to sleep, headache and head cold was not reported. This report was non-serious.
Day 1 (vaccination date 10Apr2021) - did not notice any symptoms other than soreness on left arm which was the injection site.  Day 2 post vaccination (11Apr2021) -  headache like symptoms where there was heavy pressure on the back of the skull (Occipital knob/bone and around the parietal bone), felt clammy and hot/sweaty, shortness of breath, and very fatigued and nauseous. Temperature seemed to fluctuate throughout the day around 100 degrees almost like a low grade fever.   Day 3 two days post vaccine (12Apr2021) - headache like symptoms seem to have settled but still felt clammy / sweaty / hot.   Day 4 (13Apr2021) Injection site in left arm is still swollen and sore. Shortness of breath still present.
Pt developed palpitations in weeks following booster dose of Pfizer Covid-19 vaccine
After giving FLUVIRIN vaccine patient went to sit in pharmacy wtg area. In about 10-15 minutes patient started sweating profusely, turned very pale and blood pressure dropped to 66/38. Monitored BP until EMS arrived.
Extremely fatigue, feeling of incoherent, extremely high blood pressure, almost passed out.
Intense aches and pains when I sit for a bit and tries to get up very painful.
pt noticed erythema and edema of bilateral ears followed by cheeks about 2 hours after vaccine, denies trouble breathing or swallowing, no swelling of lips or tongue
On 2/3/01 at 09:00, mom reports left arm swollen, red and hot to touch. At 14:55 in health dept, left deltoid warm to touch, red area approx. 2" X 2". Mom instructed to apply cool compresses next 24 hours, then warm compresses. Medicine for fever every 4 hours for 24 hours.
Side effects/anaphylaxis; This spontaneous report was received from a nurse and refers to an unspecified patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On an unknown date, the patient was vaccinated with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, albumin status rHA lot #U025199, expiration date not reported but upon internal validation established as 13-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced side effects. At the time of reporting, the outcome of the side effects was not known.   The causal relationship between side effects and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  This is a non-valid case due to lack of patient's identifiers.  Follow-up was received from a consumer on 03-AUG-2023 referring to the 21-year-old female patient. The patient had no pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications (reported as "none"). She was not ill at the time of vaccination.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the left deltoid, corresponding to the third dose of the vaccine. Additionally, the patient was also vaccinated with an unspecified varicella vaccine (manufacturer unknown) (reported as "varicella") lot # reported as "W006413" with expiration date reported as "23-FEB-2024", subcutaneously in the left arm, for prophylaxis (strength and dose were not provided). The vaccines were administered as private doctor's office/hospital.   On 28-APR-2023, the patient experienced anaphylaxis. The patient's mother took her to the emergency room (ER) and a allergy testing was done (results not provided). She required X-ray (result not provided) and was treated with intravenous medications and with epinephrine, methylprednisolone sodium succinate (SOLUMEDROL), famotidine (PEPCID) and ammonium chloride (+) diphenhydramine hydrochloride (BENADRYL). She also received oral antihistamines and steroids at home. The patient responded to treatment and recovered from the event on 27-JUN-2023. The rechallenge and rechallenge results were reported as positive for the suspect vaccines.  The reporter considered the event to be related to the suspect vaccines.  The reporter considered anaphylaxis to be a life-threatening event and also a medically significant event.  Follow-up information provided patient's identifiers, therefore, the case was considered as a valid case.
TIA, inability to walk, transfer, unresponsive for approx 2 minutes with right side weakness.
I started to have a fever, headache, and muscle aches around 24 hours after my vaccine. I let the fever ride until I started to subside on its own. The fever last around 8 hours. After the fever broke I took some tylenol and ibuprofen for my headache.
Patient complained of redness, inflammation and warmth at site of injection 6 days after immunization. RPH advised to apply ice pack. RPH advised pt. to monitor and come back if reaction worsens. Pt. came back next date b/c symptoms worsened and saw doctor. Dr said it was an infection and prescribed KELFEX.
2-3 days after vaccines, right upper thigh had few water bubbles with redness. 5 days after receiving vaccines, area became hard.
Aching and all that so, For couple of days to first two vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient).  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2021 (Lot number: EN6204) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Common variable immunodeficiency" (unspecified if ongoing); "Verbatim: Diabetic Type-I" (unspecified if ongoing), notes: Verbatim: Diabetic Type-I; "Verbatim: Coronary artery disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching and all that so, For couple of days to first two vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concern: Consumer stated, "My name is (name) (not spelled) last name spelled (name). My phone number #. I have an Immune deficiency so(Intent history; Not further clarify, Hence not captured in tab), 2 week ago, On Monday, I would have, Got my third booster and I am just wandering because I had side effect, Aching and all that so, For couple of days to first two vaccine. I think so, I am on two weeks off. I am trying this, I had this, Headache, Muscle ache and then had slightly fever so, I am afraid, I am wondering, If no longer we have interaction for this how." Consumer stated, "I take medicine for my heart, I would have all day if I tell you my medication, I have a list that long."(further clarification unknown). Consumer stated, "I am diabetic type-I, I have got a heart condition(further not clarified hence not captured in tab), I have got a coronary artery disease and I have an immune deficiency It's called CVID- common variable immuno-deficiency syndrome."   No follow-up attempts are possible. No further information is expected.
5 month old was administered Quadracel in the left leg.; 5 month old was administered Quadracel in the left leg.; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a Health Care Professional.  This case involves a 5 months old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (QUADRACEL). (lot: C5656AA, expiry date: 13-Aug-2021), via unknown route in the left leg, on 10-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due product administered at inappropriate site, product administered to patient of inappropriate age. It was reported a 5 month old was administered Quadracel in the left leg. The caller stated that their office has DTaP and IPV vaccines in separate forms in their office, but only one of their two vaccine tracking systems flagged Quadracel as not being appropriate in the 5 month old.  At the time of reporting, the patient had no 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.
Pain at injection site radiating down to elbow, up shoulder and neck. Muscle very tight (like a muscle spasm) No redness, no fever, no edema. Client came in 10/14/04 after 2 days of above complaints.
Right side facial paralysis; Started on Prednisone/Valtrex for diagnosis of Bell's Palsy.
TREMOR, COGNITIVE DECLINE, CHEST PAIN, ABNL BRAIN SCAN
Mouth sores occasionally; Guilt feeling; Had thrush following vaccine; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (Mouth sores occasionally), CANDIDA INFECTION (Had thrush following vaccine) and FEELING GUILTY (Guilt feeling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen and METHOTREXATE (unknown route) at an unspecified dose. In 2021, the patient experienced CANDIDA INFECTION (Had thrush following vaccine). On an unknown date, the patient experienced STOMATITIS (Mouth sores occasionally) and FEELING GUILTY (Guilt feeling). At the time of the report, STOMATITIS (Mouth sores occasionally) outcome was unknown and CANDIDA INFECTION (Had thrush following vaccine) and FEELING GUILTY (Guilt feeling) was resolving.            The concomitant medication was not reported by reporter. It was reported that patient experienced guilt feeling of losing husband after placing him into hospice care and assisted living home. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Vomiting,  became unresponsive,  couldn't move off of recliner
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 8.3 and R; 24, 9 and R; 24, 8.5 and R; 24, 8.4 and R; 24, 8.1 and R. the storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Soon after shot felt sweaty - dizzy - that is all he remembers.  States he was very nervous on arrival and does not like needles.   Patient observers states they noticed patient coughing and then he passed out.