chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/02/2121 1:30AM He experienced extreme pain between the elbow and wrists of both arms. The pain and stiffness lasted until 7:00am when it began to partially and completely resolve itself. By the midmorning it was gone. For the next 5 days it was gone.   It was recommenced slowly on 11/07/2121, culminating in weakness in both legs, but particularly left leg - it was "wobbly" and he was "limping". On 11/08/2021, there ws continued pain and weakness in hands, forearms and calves and it slowly came more difficult to move around. On 11/09/2021 there was further progression of pain and weakness in arms, legs, hands, fingers and lower back. At 4:45pm 11/08/2021, he walked slowly down our 2-1/2 flights of stairs to drive to the doctor in the city. on the way, 45 minutes  later, he couldn't lift his arm to the top of the steering wheel to make a right turn, and I had to lift it for him. By 6:00pm, he walked with a cane and with my help into the doctor's office. By 7:00 Doctor diagnosed with neuropathy. Doctor helped him to the car which I was driving and by 7:30pm he could not lift his left leg into the car, Doctor had to help him and lift the foot himself. Once home we struggled to enter the house and he was able to clime one of the step flights of stairs with the cane and my help. The second one, he couldn't climb and collapsed on the 4th step, only able to go up the rest of the stairs o his butt, pushing himself with his feet- there was no strength in his arms. He crossed the long hallway flat on his back, managed with my help to reach & get on the bed and he called 911.   one in the emergency room of the hospital, they diagnosed Guillain Barre' syndrome and when he got admitted, they administered a steroid (IV) and IVIG. By the next morning he was able to walk with a walker to the toilet to void. He got the following 4 IVIG treatments, went to Rehab and has been steadily regaining function. He's now doing outpatient rehab- still using a cane to walk.
No adverse effects were reported; An expired dose of VAQTA was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 04-APR-2019, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) lot # R009952 (expiration date: 17-MAR-2019) (the dosage regimen information was not reported) for prophylaxis. No adverse effects were reported.
Itchy rash at injection site  about 3 inches in diameter started on 2/19,  8 days after vaccination.
Metallic taste in mouth and smell in nose; Metallic taste in mouth and smell in nose; This is a spontaneous report received from contactable reporter other HCP. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Nov2021 15:15 (Lot number: 32030BD) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Pineapple; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Reactive airways disease" (unspecified if ongoing), notes: Reactive airway disorder; "Hypertension" (unspecified if ongoing), notes: Htn. Concomitant medication(s) included: DYAZIDE; ESTRACE. Past drug history included: Botox, reaction(s): "Urinary urgency", notes: Other medical history: Urinary urgency on botox injections; Cefepime, reaction(s): "Drug allergy", notes: Known allergies: cefepine. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 27Nov2021 15:45, outcome "not recovered" and all described as "Metallic taste in mouth and smell in nose". Therapeutic measures were not taken as a result of dysgeusia, parosmia.  Additional information:-Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 11-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Pt rt leg w/hard, reddened area @ inject site; Pt cried continuously for 4.5 hrs; would fall asleep when held by mom; low grade fever; mom gave APAP;
Patient had been healing from Herpes Zoster, Right T9 dermatome. The day after her second Moderna vaccine, the rash worsened. It became more painful and the drainage increased, so much so, that her clothes were soaked by the drainage.
No additonal AE's; A nurse reported that an expired dose of VAQTA pediatric vaccine was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 28-DEC-2022, the patient was vaccinated with expired dose of pediatric hepatitis a vaccine, inactivated (VAQTA) 25U intramuscular injection, lot #U031911 has been verified to be valid, expiration date was reported as 11-NOV-2022 for prevention of hepatitis A infection (dose, anatomical location, and route of administration were not provided) (expired product administered).
PERSISTENT RASH/LITTLE BUMPS ON BOTH LEGS; CHILLS; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 175 pounds, and height was 57 inches. The patient's concurrent conditions included ceclor allergy, occasional alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no diagnostic data available. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination at left arm. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced body aches. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced persistent rash/little bumps on both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 15-MAR-2021, and chills, and fever on 13-MAR-2021, and had not recovered from persistent rash/little bumps on both legs. This report was non-serious.
c/o pain & swelling, lt deltoid first day p/vax & hot to touch & entire arm stiff & painful w/movement x 4 days;c/o n/v x 3 days, fever 100-101 x 5 days;two areas of splotchy redness medial aspect of lt upper arm next to Td site;
Patient got flu-like symptoms; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who got flu-like symptoms (Influenza like illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu-like symptoms (Influenza like illness) (Unknown latency) everytime following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Patient presented 12/9/15 and stated that she had been experiencing muscle soreness when she lifts her arm ever since she received a Pneumovax vaccination on 10/14/15.
Arm pain and fatigue.  Waking up with shooting pain in arm.  Numbness and fatigue in legs.  Persistent fatigue and muscle twitching still two months after injection.  In forearms, thighs, calves, buttocks, eye area.  Neck stiffness.  inflamed lymph nodes.  longer recovery times from exercise.  mild to moderate chest pain.  severe shoulder pain return in left arm after exercise.  Occasional
Pain in shoulder radiating to my neck and right side of my head. Very painful to touch and move get light headed from the pain.
Noted a 6x13cm red area to injection site.  Area warm to touch, edematous, non-tender, not itchy.  Resident had no complaints  and stated she didn't even know it was there, VS stable,  ROM to extremity WNL, will continue to monitor in house and alert PCP as needed.
extreme soreness in the area of uterus; sore arm; has fibroid tumors and on Saturday night, she experienced very severe cramping from them; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 23Apr2021 at 11:30 AM (at the age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  Medical history included chronic pain, fibromyalgia, ongoing fibroid tumors, and penicillin allergy. Concomitant medications included pregabalin (LYRICA); diazepam; ibuprofen; morphine; and multivitamins.  The patient received the shot on Friday on 23Apr2021. The patient experienced sore arm on Saturday (24Apr2021), which is expected. The patient also has pre-existing fibroid tumors, and on Saturday night (24Apr2021), she experienced very severe cramping from them. On Sunday (25Apr2021) and Monday morning now (26Apr2021), the patient is experiencing extreme soreness in the area of uterus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the events.    Information on the lot/batch number has been requested.
This medically confirmed spontaneous report (initial receipt 02-OCT-2014) concerns an 81-year-old male patient. On 02-OCT-2014, the patient received excursioned AFLURIA (batch number: 09949211A) via intramuscular route. The AFLURIA multidose vial was kept in room temperature for about 12-14 hours. The refrigerator temperature read 55 degree Fahrenheit, but the reporter did not believe that it was accurate. Outcome was not reported. Reporter's comments: The reporter stated that th patient was fine.
The vaccine might not have been effective on her; she received 3 different doses of the vaccine, the first one in Jan2014, the second one in Feb2016 and the last one in Sep2019.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13 solution for injection in pre-filled syringe; lot number and expiry date: unknown), via an unspecified route of administration, first dose in Jan2014, second dose in Feb2016, and third dose in Sep2019 , at single doses, for immunization. Relevant medical history included asthma, high blood pressure and allergies. Concomitant medications were not reported. The patient previously received flu vaccine for flu vaccination and experienced allergic reactions. The patient wanted to know if there was a previous version of PREVNAR 13. She wanted to know how often a patient should receive a shot. The patient stated that she received 3 different doses of the vaccine, the first one in Jan2014, the second one in Feb2016 and the last one in Sep2019. She stated during the call that her physician indicated that she should receive an additional dose because the vaccine might not have been effective on her. Outcome of the event "The vaccine might not have been effective on her" was unknown. The patient also wanted to know if she can receive the COVID-19 vaccine manufactured by Pfizer if she has medical history of allergies, asthma and high blood pressure and if she can receive a list of the risks of the vaccine.   No follow up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
2 days after vaccine had significant back pain.  Lower back with excruciating pain. Chest muscles became stiff       Was difficult to walk or sit.   Then the next day was having breakfast and had an allergic reaction to food that I have eaten regularly.  I had an allergic reaction for the first time in September to a different food but it was same reaction.  Significant periorbital edema  to where my eyes were almost completely swollen shut.  No breathing issues.
woman who passed away after receiving the Moderna bivalent booster dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (woman who passed away after receiving the Moderna bivalent booster dose) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was provided.  Company comment: This is a spontaneous case female patient of unknown gender, with no medical history, who experienced unexpected fatal serious (medically significant) event of death (reported as woman who passed away after receiving the Moderna bivalent booster dose), which occurred unspecified days after booster dose of mRNA-1273 bivalent BA.1 vaccine. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 bivalent BA.1 vaccine is not affected by this report.; Reported Cause(s) of Death: woman who passed away after receiving the Moderna bivalent booster dose
upper respiratory/sinus (non-covid) Cold; Yeast infection of all things on my face/genital area; upper respiratory/sinus (non-covid) Cold; on/off joint pain; This spontaneous case was reported by a patient and describes the occurrence of the second episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold), FUNGAL INFECTION (Yeast infection of all things on my face/genital area), the first episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) and ARTHRALGIA (on/off joint pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Jun-2020. Concomitant products included LANSOPRAZOLE and FAMOTIDINE (PEPCID [FAMOTIDINE]) for GERD, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced the first episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) and ARTHRALGIA (on/off joint pain). On 21-Jun-2021, the patient experienced FUNGAL INFECTION (Yeast infection of all things on my face/genital area). On 16-Sep-2021, the patient experienced the second episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold). In 2021, last episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) had resolved. At the time of the report, FUNGAL INFECTION (Yeast infection of all things on my face/genital area) and ARTHRALGIA (on/off joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Polymerase chain reaction: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-331767 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant Follow up-events added
Three days following the vaccination I developed acute shortness of breath while sitting at work.  The shortness of breath episodes progressively worsened over the course of 4 days which required the use of an albuterol inhaler to treat the acute symptoms.   The shortness of breath started to increase in both frequency and severity.  On day 7 I began to develop a headache, cough, and fatigue.   Day 9 I developed  a fever 100.8.  I went to urgent care where I was prescribed Qvar steroid inhaler and Azithromycin antibiotic.  A covid-19 test was performed.    Covid test negative.   Today is Day 12, I have 2 days left of antibiotic, shortness of breath is better following steroid inhaler use but returns approx. 4 hours following treatment.  I continue to have a headache, productive cough, and fatigue.
Developed pain, red, hot injection site within minutes of vaccine ( Left Deltoid). C/O chirpy cough and generalized itching of arm and leg, VS WNL, lungs clear, face flushed, 2 small hives noted on chest. Benadryl 50 mg po,  EPI .3 by EPI PEN. Transported to local hospital for observation. Released 1 hour later.
At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I thought they were bug bites and I wasn't sure where all the pain was coming from and I ended up in the emergency room where I was diagnosed with shingles. After my second shot I started getting shingles by laterally on my right side, but I was already on medication so it didn't get that bad. I also have a lot of joint pain and burning pain in my hands and wrists that shoot up my arms and haven't stopped since the symptoms started. It's much worse at night and keeps me up from sleeping. I have also have been very forgetful and my mind is always cloudy.
inflammation in the back; barely sleep at night; feels like there is a knot in her back; hurts when breathing; back pain for 3 or 4 days; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back pain for 3 or 4 days), INFLAMMATION (inflammation in the back), INSOMNIA (barely sleep at night), MASS (feels like there is a knot in her back) and PAIN (hurts when breathing) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Penicillin allergy. Concomitant products included VITAMIN B COMPLEX (VITAMIN B [VITAMIN B COMPLEX]), COLECALCIFEROL (VITAMIN D 3) and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.    On 24-Apr-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced BACK PAIN (back pain for 3 or 4 days). On an unknown date, the patient experienced INFLAMMATION (inflammation in the back), INSOMNIA (barely sleep at night), MASS (feels like there is a knot in her back) and PAIN (hurts when breathing). At the time of the report, BACK PAIN (back pain for 3 or 4 days) had resolved and INFLAMMATION (inflammation in the back), INSOMNIA (barely sleep at night), MASS (feels like there is a knot in her back) and PAIN (hurts when breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Information regarding Prevnar was received from a healthcare professional regarding a female patient who experienced fever of >103F. The patient received the first dose on an unspecified date. A physician reported that his daughter experienced a fever of >103F on an unspecified date. The outcome is unknown. See related case (s): HQWYE456022MAR06 (adverse event, non-expedited) and HQWYE517724MAR06 (adverse event, non-expedited). No additional information was available at the time of this report.
Narrative:  SUBJECTIVE: The pt reported feeling sharp pain at L side, mid clavicular, deep to costal edge. He reports onset shortly after receiving the COVID-19 vaccine booster (1305hrs). He denies HX of heart conditions but has had stomach ulcers. He has never had this feeling at this location before. He reports just getting discharged from the hospital for blood clots in his neck and  lower legs. He has not eaten since yesterday. Additionally, he reported light headed/dizziness when standing. He reports this symptom is common for him, although it goes away a little quicker. He feels the need to take deeper breaths but is not SOB (rate is not increasing, he does not require a position change, and he is speaking in full sentences with a single breath). OBJECTIVE: The pt ambulated to the EKG room steadily without loss of balance. He has no s/s of distress or SOB. He is speaking in full, logical sentences without pausing for breath. ASSESSMENT: Skin is pink, warm, and a little damp on legs. Stroke assessment was negative. Heart sounds S1 and S2 were audible and regular without additional sounds. Lung sounds were dim but clear. Abdominal sounds were regular in all 4 quadrants. EKG indicated NSR with piossible L atrial enlargement and incomplete RBBB. PLAN: Per the PA- The pt was given an oatmeal cookie with pecans and cranberries and water. He was monitored by an RN in the lobby while waiting to determine if he needed to go to the ER. The RN reassessed and it was decided that he should go to the ER. EMS was called and the pt was picked up shortly after and brought to local ER.
About one week after receiving my 1st dose, I began having constant dizziness and vertigo. The ground feels like it's moving and I often feel off balanced. I feel it sitting, standing, walking. It has been constant since about June 9th to today, June 29th.
Hepatitis B surface antigen positive  This case was reported by a nurse and described the occurrence of hepatitis B surface antigen positive in an 80-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  Medical history included renal failure (cause not specified) requiring hemodialysis.  On 08 March 2006 the subject received 2nd dose of Energix-B (lot AHBVB166AA).  On 10 March 2006, 2 days after vaccination with Energix-B, "a lab test demonstrated a positive hepatitis B surface antigen." On 13 March 2006, a hepatitis B viral DNA assay was negative.  The subject was negative for hepatitis B surface antigen when she was retested on 27 March 2006.  The nurse considered the event to not be related to vaccination with Twinrix.