chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LEG PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 22 year old female. 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 not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced joint pain. On 17-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and joint pain. This report was non-serious.
bed ridden for 4 days, bruised at injection sight, fuzzy, dizzy, body aches, cramping, nausea, vaginal bleeding (this is the one I was worried and upset about), weak.  I am still dizzy 4 days later and weak.
Initial unsolicited report received from a pharmacist on 08-Jan-2016. This case involves a 60-year-old female patient who was vaccinated with first dose of FLUZONE TIV (batch number: UI195AA expiry date: 30-Jun-2015, dose and route of administration was not reported) in left deltoid on 21-Oct-2014. Patient had no illness at the time of vaccination, no known allergy and no medical history. Concomitant medications were not reported. On 21-Oct-2014, same day after vaccination, the patient experienced normal soreness at the injection site but, that over the past year the numbness tingling and pain has been increasing and patient was barely able to use her arm. No laboratory investigations were performed. It was reported that the patient denied to take medical treatment and patient was urged to seek immediate medical treatment as this appeared to be an evolving issue that could have other medical cause. At the time of this report the patient was not recovered. Documents held by sender: none.
Fever, headache for 3 days Rash on my chest and back, and swollen and pain armpit/lymph nodes began on day 2 and still current
3-month right shoulder and proximal pain/tenderness with limited shoulder range of motion, limited by pain
Information has been received from a medical assistant via medical records concerning a female baby whose mother was vaccinated with the first dose of VARIVAX (Merck) (Lot # 659932/1790U) on 22-APR-2008. It was reported that the baby was born on 17-JAN-2009, at 39 weeks of gestation, via spontaneous vaginal delivery, 7 pounds and 3 ounces, weight was 50.8 cm; head circumference 33.7 cm. The baby did not require any extraordinary means of resuscitation at delivery. The apgars were 9 and 9. The initial newborn examination was essentially within normal limits. The baby's blood type was O positive. It was reported that the baby voided and stooled within 24 hours. The baby did receive hepatitis B virus vaccine rHBsAg (manufacturer unknown) prior to release. It was reported that on 21-JAN-2009, baby noted to have scant scleral icterus (outcome unknown). On 05-FEB-2009 (also reported as 05-FEB-2008) the baby had occasional eye crusting, baby was also noted to have some nasal congestion starting on approximately 30-JAN-2009. On 19-MAR-2009, the baby's eye was still goopy at times but was better than previous, on exam tearing was noted in left eye. Lacrimal duct stenosis was discussed at length with the patient's mother. At the time of the report the outcome of the patient was not reported, Lacrimal duct stenosis was considered to be a congenital anomaly. The mother's experiences were captured in WAES # 0806USA01108. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/26/2022 Discharge Date: Dec 28, 2022 COVID positive Date: 12/26/2022  PRESENTING PROBLEM: Bilateral pulmonary embolism [I26.99] Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type [I26.99]   HOSPITAL COURSE: Pt is 89 y/o male with past medical history of diastolic heart failure, CAD, stroke, HLD, HTN, left sided carotid artery disease, permanent afib, prostate cancer w/ recurrence and LN involvement undergoing radiation therapy who presented with shortness of breath and found to have small bilateral PE and found to be positive for COVID 19. In ED, pt VSS on RA. CBC and CMP largely unremarkable. CTA thorax/abd/pelvis showed small bilateral non-occlusive PE w/o right heart strain. He was started on heparin and admitted for further treatment.    Following admission pt was maintained on heparin drip. Echo was obtained showing LVEF 55%, basal to mid inferior wall segment w/ moderate hypokinesis, no note of right heart strain. This was discussed with cardiology who notes this is not a significant change from prior. High sensitivity troponin were negative on admission and chest pain resolved.  BLE US was negative for DVT. Hematology was consulted as pt was on pradaxa when PE occurred. Hematology did not feel true failure given known infection and small clot burden. He was transitioned to lovenox to complete 5 day bridge before resuming pradaxa. He will follow up with hematology otpt. He remained asymptomatic from COVID standpoint. Pt was able to ambulate independently and did not have any desaturations. He was instructed on giving lovenox injections. He was discharged home in stable condition on 12/28.
Severe swelling of the arm - height of swelling localized about 1/2 cm diameter of dime. Appeared bluish/purple.
Fever, injection site soreness, fatigue. Fever and fatigue subsided within 24 hours of onset. Soreness persisted for 48 hours.
After patient received Vaccine she started immediately  to look very pale and stated she was not feeling well. Patient reported feeling numbness in her right arm and radiating to her left arm . Patient given oxygen via nasal canula , vital sign taken and offered orange juice to drink. patient stated has no breathing concerns or chest tighten. She continued to complain of numbness to both arms and now radiating to her face. patient also displayed cramping of both her hands. Ambulance notified and patient transported to local hospital.  Patient was orientate, responsive  and alert .
Pt recvd Engerix-B in MAY91, JUN91 & NOV91 p/3rd dose pt exp pain, erythema & induration @ inject site; these events occurred in 2 pts (also EUB911257); no tx was given;
Swelling and redness at injection site, fever, dizziness, fatigue, headache, body aches. Treated with ADVIL and ice pack. Worse following day.
Tinnitus after second does of vaccine. Became noticeable about 12 hours after 2nd dose was administered. Has been a persistent, high pitched frequency in my ears ever since.
Two days after my second dose, I became sick for 7 days. The symptoms came on immediate, chronic coughing and sneezing, head cold symptoms, fatigue, chills with no fever. The symptoms ended immediate after seven days.  I though it could be seasonal allergies; however, I have never had seasonal allergies with this strength and duration.
pt recv vax & exp 3 episodes of LOC, disoriented on arousal; sz x 1; referred to ped Neurologist;
Sore arm at injection site then progressed into left armpit and left armpit became swollen and tender.
1 day after flu vaccine, pt developed fatigue, light headedness, myalgias, chills, subjective fever; headache, intermittent numbness hands/feet.
Rash on forearms, chest and shoulders,  seems to be more sensitive during daylight hours.
lt deltoid red, hot to touch area >50mm w/swelling/painful-no known hx of prev TD-c/o discomfort immed p/vax; instructed to apply ice x next 24hrs then warm soaks;
EPISODES OF WATERY DIARRHEA/CHRONICITY PROMPTING HIM TO GO TO THE TOILET AROUND 10 TIMES A DAY; DEPRESSION; LOST AROUND 20 POUNDS OF WEIGHT; SOCIAL ISSUES; This spontaneous report received from a parent concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy man. 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 and has been requested. No concomitant medications were reported. On 01-JUL-2021, Laboratory data included: Laboratory test (NR: not provided) Unknown. On an unspecified date, the patient experienced lost around 20 pounds of weight, depression, social issues, and episodes of watery diarrhea/chronicity prompting him to go to the toilet around 10 times a day. Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from episodes of watery diarrhea/chronicity prompting him to go to the toilet around 10 times a day, and lost around 20 pounds of weight, and the outcome of depression and social issues was not reported. This report was non-serious.
Angina like symptoms/Pressure and sharp pain around heart; may be she had got myocarditis or something; lightheaded/dizzy; Pressure and sharp pain around heart; Inflammatory markers higher than normal; chest pain just solely around heart; This is a spontaneous report from a contactable consumer(patient, not pregnant). This 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0158) at single dose via an unknown route in left arm on 07Apr2021 10:00 AM at 43-year-old for Covid-19 immunization. Medical history included known allergies with penicillin, dust, cats, dogs, horses. Patient weight was 203 (pounds). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no any other medications the patient received within 2 weeks of vaccination. About 30 minutes after being vaccinated patient was very lightheaded/dizzy. The vaccination site was less than 7 minutes from home but she had to pull over and ask her husband to stay on phone with her. Angina like symptoms developed within an hour. Pressure and sharp pain around heart (only.) Advice nurse was called. Patient saw primary care facility, EKG was done. Patient was referred to Cardiologist, had two tests and ECHO done. Both test showed inflammatory markers higher than normal. It was further reported that what happened was right after she had the vaccination, she felt this sort of pressure in chest and it was only, they thought that may be she had got myocarditis or something. And it was like it lasted about 4 to 5 weeks and it was actually to the point where the doctor, cardiologist wasn't sure if he wanted to take the second vaccine. He wanted to wait until the results of echo came back and even though there was slight, patient did not know what they would call it vibration or abnormality very small. He notice, he thought she would be okay. She had ad chest pain just solely around heart, it wasn't anywhere else and just kind of this heavy sort of like pain, but it wasn't heart attack and she did not have any underlying health conditions over all, she was pretty healthy. Event onset date was 07Apr2021, the day that she took the shot. Pain around heart had dissipated. Outcome of "may be she had got myocarditis or something" was unknown. Outcome of the other events was resolving. Reporter seriousness for the report was unspecified. The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Patient had both of vaccinations as of 05Jun2021 but she believed was an adverse reaction to the first.
This spontaneous report was received from a nurse concerning a 12 yeas old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 16-JAN-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 lot number M024261 with expiration date of 30-JUL-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008111: Original case: 1701USA008111.
I first noticed extreme tiredness fever and headache. Two months later my acupuncturists notice that my pulses were weak on or about February 23 2022. On April 10 2022 I began to have severe abdominal pain with nausea and vomiting which continues until this report. SIBO was diagnosed 11/09/2022.
Body ache; Chills; Fever; This spontaneous report received from a patient and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch unknown) dose was not reported, administered on 07-MAR-2021 at 08:10 am for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced chills, body ache and fever. The patient's arm was not sore at all. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fever, chills and body ache was not reported. This report was non-serious.
Pt. received a second dose of Pfizer today, 14 days after her first dose. Pt. received er first dose at the race track and was instructed to make her own appointment for a second vaccine.  Pt. made the appointment online for today and went through the process to include vaccination.  It was after the vaccination that a staff member recognized that she had her second dose a week earlier than recommended.  No adverse outcome.
Client came into our clinic requesting his first dose of Moderna 10/28/2021.  Client received what we thought was his first dose.  Client had actually received doses of Pfizer 9/9/2021 and 9/25/2021.
within 5 minutes of shot had mild nausea but wasn't sure that it was related to shot, 17 hours later had mild headache, within an hour had fever around 99* with bigger headache and nausea, within 2 more hours fever was at 101.5* and bigger headache, by hour 22 after shot had fever at 103* mild nausea and extreme headache, at hour 23 after shot took ibuprofen, despite ibuprofen headache was so extreme it woke me up from a nap, continued ibuprofen every 5 hours until 64 hours after shot. Shaking/Chills present with the higher fevers- hours 20-30. Nausea discontinued 24 hours after shot. Headache decreased to dull mild headache at 29 hours after shot, headache stayed mild and did not disappear until 88 hours after shot. Fever dropped to low grade 99* which maintained (even with ibuprofen) from hour 36-64 after shot. Mild sore throat was present from 36 hours after shot until 64 hours after shot. Fatigue was present from 17 hours after shot until 84 hours after shot.
Severe rash thighs, buttock, torso. It was scattered on lower legs, arms, upper back/chest. It lasted 18 days. Went to Urgent Care a few days after it started due to terrible itch. Got a strong antihistamine which barely helped and used Aveeno cream that just took the edge off. Rash disturbed my sleep. So itchy that started bleeding.
systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2); This is a literature report.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2)". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: positive, notes: (1:2560); positive; positive; Biopsy skin: revealed a superficial and deep perivascular, notes: and periadnexal infiltrate comprised of lymphocytes, with occasional neutrophils and neutrophilic debris. These features were consistent with a neutrophilic urticarial dermatosis, which can often be associated with SLE, and thus, pointed to a diagnosis of SLE given the dermatologic and laboratory findings.The scalp lesions were unable to be biopsied due to patient refusal; Complement factor C3: 62.3 mg/dl, notes: low complement levels; Complement factor C4: 11.8 mg/dl, notes: low complement levels; C-reactive protein: 5.1 mg/l, notes: elevated; Examination: ill-defined, erythematous, tender plaques, notes: and nodules on the face, arms, frontal scalp, legs, and chest. The patient also developed scarring alopecia with scalp lesions clinically consistent with discoid lupus erythematosus; Laboratory workup: revealed leukopenia; Protein urine: 54.2 mg/dl, notes: elevated; Urine protein/creatinine ratio: 237 mg/g, notes: units: mg/gm elevated; White blood cell count: 2520 /mm3, notes: units: /UL leukopenia. Therapeutic measures were taken as a result of systemic lupus erythematosus.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-SYSTEMIC LUPUS ERYTHEMATOSUS  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
DIZZINESS, HEADACHE, JOINT PAIN, MUSCLE ACHES, FEVER 101F,  CHILLS, CLAMMY SKIN, HOT FLASHES, SWEATS, NAUSEA, LOSS OF APPETITE, EXTREME EXHAUSTION, SEVERE PAIN WHERE VACCINATION ADMINISTERED, VACCINE LOCATION SWOLLEN - ADVERSE REACTION OCCURRED WITHIN 16 HOURS OF ADMINISTRATION, AND LASTED 36 HOURS CAUSING ME TO MISS A DAY OF WORK
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-DEC-2014, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial had been punctured on Wednesday 2:00 PM on 28DEC2022.Bivalent Dose administered today 30DEC2022), PRODUCT STORAGE ERROR (Stored in the refrigerator between initial vial puncture and dosing administration) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1) in 2021, MODERNA COVID-19 VACCINE (Dose 2) in 2021, MODERNA COVID-19 VACCINE (1st Moderna booster (lot number 032H21A and expiration date 24MAR2022)) on 21-Dec-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (vial had been punctured on Wednesday 2:00 PM on 28DEC2022.Bivalent Dose administered today 30DEC2022) and PRODUCT STORAGE ERROR (Stored in the refrigerator between initial vial puncture and dosing administration).    No concomitant medications were reported.    No treatment medications were reported.
Sudden Sensorineural Hearing Loss / mild hearing loss; tinnitus/roaring sound; This spontaneous case was reported by a consumer and describes the occurrence of NEUROSENSORY HYPOACUSIS (Sudden Sensorineural Hearing Loss / mild hearing loss) and TINNITUS (tinnitus/roaring sound) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced TINNITUS (tinnitus/roaring sound). On 05-Oct-2021, the patient experienced NEUROSENSORY HYPOACUSIS (Sudden Sensorineural Hearing Loss / mild hearing loss). At the time of the report, NEUROSENSORY HYPOACUSIS (Sudden Sensorineural Hearing Loss / mild hearing loss) and TINNITUS (tinnitus/roaring sound) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2021, Acoustic stimulation tests: abnormal (abnormal) abnormal. On an unknown date, Magnetic resonance imaging: normal (normal) she had a MRI to rule out a tumor and result was normal with no findings..     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.   Patient experienced tinnitus which was described as a roaring sound like a clothes dryer running all the time and never goes away.  On 05-Oct-2021 the caller stated she went to see an ENT Doctor and was diagnosed with Sudden Sensorineural Hearing Loss after having a hearing test. She stated it was a mild hearing loss and didn't need a hearing aid.  The caller also reported she had Multiple Sclerosis and the results were normal with no findings. The caller did not receive the second Moderna COVID-19 dose. Concomitant product use was not provided by reporter. Treatment information was not provided.
I initially had a sore arm which was anticipated but a few days later I noticed pain from a swollen lymph node(s) in the same armpit (about 3-4 days later) which lasted several days. Over the next few days I experienced diarrhea, weakness, fatigue, extreme neck pain (on the same side as the injection), swelling and redness of my arm at the injection site (9 days after), a few hives on my face. It is currently 2 weeks after I've received the vaccine and I feel extreme muscle aches, slight headache, and pain in my upper abdomen and back. I was in very good shape prior to receiving this vaccine but now when I go to the gym I cannot lift as much as I could before, nor do I have energy like I did prior to the vaccine.