chrisvoncsefalvay/vaers-outcomes huggingface dataset:
To start  the nurse was very evasive like she was hiding my injection it was weird, I didnt think anything about it and went home. then in march I started getting symptoms tenderness in my nipple area and Im a male underneath my nipples was very hard like I was growning breats and start get large ,  i was like this is strange and then I the fluid was so heavy in my arm like it didnt want to pass after weeks.  Then my ankles start to overly swell ok this is also strange never happen before and severe stiffness with pain and darkness in skin color of my ankels  and I still have these sympton today.
Temp 103 degrees, headache, generalized body aches, no localized reaction at injection sites. Sxs reported to our office approximately 96 hours after administration. Sxs resolved spontaneously in 24-48 hours after administration. Muscle soreness only at injection sites.
Flu vaccination given 10/10/11 about 17:00 p.m. in right lower deltoid intramuscular; noted 10/11/11 evening 20:00 p.m. redness and heat at injection site. Reported to employee health 10/12/11 about 10:55 AM. Area described above; given anti-inflammatory will apply warm moist heat and follow-up with employee health 10/13/11.
COVID MORE THAN ONCE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid more than once. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid more than once was not reported. This report was non-serious. This report was associated with a product quality complaint.
Went to ER for kidney stone. Passed stone but found fibroid and have scheduled a hysterectomy
Fatigue and brain fog, or dullness from Tuesday 02/09/2021 through Friday  02/12/2021.
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL1284) and on 09Jan2021 as dose 2, single (Lot number: EL1284) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "ammenorhea" (unspecified if ongoing), notes: I have had ammenorhea (absent menstrual cycle) for 6 years.; "Reaction: Allergy" (unspecified if ongoing), notes: Reaction: Allergy. The patient took concomitant medications (patient has received birth control pills within 2 weeks of vaccination). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201342119 same patient, different event, different dose/event;US-PFIZER INC-202201341882 same patient, different event, different dose/event;
10/18/2021 PT SEEN IN ER  DUE TO RIGHT HIP PAIN AFTER A FALL ONE WEEK PRIOR. ALSO COMPLAINS OF NAUSEA, VOMITING, ABD CRAMPING.  PATIENT HAS FAMILY WHO ARE COVID 19 POSITIVE. PATIENT DOES NOT HAVE COUGH, PNEUMONIA NOTED
Fast heartbeat from my normal 46 to 50, went to 158-138, when at the emergency room.
PATIENT RETURNED TO PHARMACY DAY AFTER INJECTION. BACK OF ARM SWOLLEN & RED. NO OTHER SYMPTOMES. ADVISED BENADRYL & ICE TO TREAT SWELLING. PATIENT TOLD ME HE WOULD RETURN TO PHARMACY NEXT MORNING TO HAVE ME LOOK AT IT. TOLD HIM IF IT WASN'T BETTER IN AM HE WOULD NEED TO SEE HIS DR. ADVISED HIM TO SEEK MEDICAL HELP IF CONDITION WORSENED. PATIENT DID NOT RETURN. LEFT MESSAGE FOR HIM TO CALL BUT HAS NOT RETURNED CALL.
Severe muscle spasms in my lower back, bottom, and upper legs. I also had severe shaking, and teeth chattering.  I put heat, ice, and took two Advil. Nothing helped.  The pain was debilitating. I could not get comfortable whether lying down, sitting, standing, or walking.  I went to a local Hospital Emergency Room, and the doctor felt it was a reaction to the updated Pfizer booster that I had received earlier that day. She gave me  a Valium.  I was still having muscle issues the next day, so I went to my primary care doctor. She also felt that this was related to the Covid booster. She recommended continuing taking Advil, and called out a prescription for Cyclobenzaprine 5mg.
Pt called on 2/9/18- states that she developed pain in her joints since receiving her vaccines on 1/23/18. Nursing supervisor called her back on 2/9/18 and discussed the adverse events that could occur after the MMR vaccine and that she was within the time frame of the side effects. She was also instructed to call her MD for follow up. Pt called us back on 2/20/18 and was still having symptoms. Nursing supervisor spoke with her again and discussed issues. I called pt on 2/22/18 and discussed situation with her- she is still having joint pain in her hands and left knee. She states that the pain started in her knees and went to her ankles and then to her hands. She stated that she felt achy and tired also after receiving the vaccines. Pt. did call her MD and he advised her to not receive the second dose of MMR vaccine. I advised her to call her MD and maybe he would order a titer to check her antibody titers for Rubella which was low or that he could write her a medical exemption for the MMR vaccine. Pt was needing vaccine for immigration. She will call Regulatory Authority if she has further questions.
Rash over head neck trunk emerging on 12th day post vaccine. Macular erythematous discreet and confluent. No other symptoms.
Client described an acute episode of pancreatitis approx. 48 hours post vaccine. Was wondering if immunization had any bearing. Had some recent dietary changes. Pancreatitis has been a chronic issue for this client.
2 1/2" X 3 1/2" area of redness, induration, tender right upper outer anterior thigh. Was seen in office with above symptoms on 06/08/02. Started on Keflex. Seen 06/10/02, symptoms improving.
Information has been received from a physician concerning a 52 year old female with asthma, hypertension, menopause, penicillin allergy, sulfonamide allergy and allergic reaction to antibiotics (macrodantin) who on 03-NOV-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (lot # 655501/1035F). Concomitant therapy included montelukast sodium (MSD) 10 mg once daily, estrogens, conjugated (PREMARIN0 0.625 once daily, sumatriptan (IMITREX (sumatriptan)) PRN, metoprolol tartrate (LOPRESSOR) 25 mg BID, valsartan (DIOVAN) 80 mg oral daily and baby aspirin daily. On 04-NOV-2007 the patient was not feeling well. Patient's blood pressure was 180/90 and heart rate went to 133. The patient went to the Emergency room and was hospitalized on 04-NOV-2007 with a diagnosis of viral syndrome, hypertension, cardiac dysrhythmia and allergy. The patient was discharged from the hospital on 07-NOV-2007. The patient also had redness at the injection site and swelling from the injection site down the arm. The patient called the doctor for follow up on approximately 13-NOV-2007. The patient's status was not reported. Not feeling well, viral syndrome, hypertension, cardiac dysrhythmia, allergy, redness at the injection site and swelling from the injection site down the arm were considered to be disabling, life threatening and other important medical events. Additional information has been requested.
This spontaneous report as received from a nurse practitioner referred to a female patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL on 10-JAN-2010. The patient was vaccinated with dose 2 GARDASIL on 16-FEB-2010. No other co-suspects were reported. No concomitant medications were reported. The patient was now in the office to received dose 3. No symptoms were reported. No treatment information was reported. Additional information has been requested.
Staring into space, breathing pattern changed, involuntary movements. Sudden seizure attacks->emergency room. Change in personality: no more smiles, giggle, baby babble, regress. Right arm stuck. No more eye contact, acting startled, scared.
I began experiencing vertigo, dizziness and balance issues. This did not occur until significantly after vaccination I have seen my PCP, had a balance test, blood work, sinus scan, brain MRI and PT.  No testing showed a reason for the issue. It has improved somewhat over time and with PT continuing.
Headache, Myalgia, Fever, Fever, general malaise, headache Narrative:
Almost immediately after the 2nd shot she lost feeling in her fingers/traveled both hands and arms. Then eventually her feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: SENSORY LOSS (non-serious) with onset Jul2021, outcome "unknown", described as "Almost immediately after the 2nd shot she lost feeling in her fingers/traveled both hands and arms. Then eventually her feet". The events "almost immediately after the 2nd shot she lost feeling in her fingers/traveled both hands and arms. then eventually her feet" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that her daughter had a severe side effect from the Pfizer BioNTech Covid 19 Vaccine. It was administered in Jul2021. Almost immediately after the 2nd shot, she lost feeling in her fingers. It then traveled both hands and arms. Then eventually her feet. They had seen 3 Neurologists, psychiatrists, multiple primary care physicians and no one could or was willing to help them. MRI's clean. EMG, clean etc. The reporter needed to know what to do and provided all details to Pfizer months ago  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported, but was captured based on the product indication. The healthcare professional called to report that 4 out of 18 patients have report flu-like symptoms after receiving the SHINGRIX vaccine. The reporter did not have SHINGRIX information or patient information to provide me. This case is 1 of the 4 linked cases reported by the same reporter for same event.
w/in only a few moments pt became very fussy, crying, inconsolable cont for 7 hr, assoc w/thigh redness & swelling down to knee from site;
My body became very cold.  I took two Tylenol, and took a 2 hour nap.  When I woke up I was back to normal again, feeling great.  No other issues
Information has been received from a Licensed Vocational Nurse (L.V.N) referring to a patient of unknown age and unknown gender. History medication and drug allergies were not reported. On 20-MAY-2015 the patient was vaccinated with a dose of incorrect stored RECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016. concomitant drug was not reported. At the time of reporting, no adverse effects were reported and it was unspecified if the patient sought any medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
right sided hemiparesthesia shortly; This is a spontaneous report from a contactable other HCP (physician's assistant). A 40-year-old female patient (reported in her late 30s/early 40s) received the BNT162B2 (COMIRNATY), via unspecified route in left deltoid on 27Oct2021 at 11 AM at patient age of 40-year-old as single dose (Batch/lot number: Unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Oct2021, the patient developed right sided hemiparesthesia shortly after receiving the vaccine and it had persisted for 3 hours. The reporter stated that the paresthesia was sensory in nature with no motor involvement, the patient was normotensive, and was not experiencing a headache. The reporter stated that the patient was experiencing sensory loss in the right arm and right leg and not in the face. The reporter directed the patient to the emergency department when symptoms did not subside. The outcome of the event was not resolved. The reporter stated that she was looking at an adverse event reporting resource on the web for the United Kingdom that makes note of three other people who have experienced hemiparesthesia after receiving Comirnaty. The reporter was asking for further information on this from Pfizer, particularly regarding the mechanism of action that could potentially cause this type of side effect post-vaccination.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.
Child was given vaccines dated 6-19-2017 which are expired by three days. No adverse reactions noted.
Burping Friday night and all day Saturday.  As of Tuesday, my lymph node behind my right ear started to swell, resulting on pushing on a nerve.  Neuropathy on right side of body from halfway up my head to halfway down my chest, all down my arm, and in the heels of both feet.  Right leg has spots of neuropathy.
Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Patient was 14 weeks pregnant when given the influenza vaccine. The nurse/ MA cleaned the deltoid area and then injected the patients shoulder joint with the vaccine. Nurse mentioned when taking the vaccine out "that got hard to push in there." Patient started symptoms 1 hour post injection. Dr office was called and patient seen the following week. The NP at OBGYN, said she would not send patient to specialist because no specialist would treat a pregnant patient, ordered an x-ray and ultrasound because patient asked for it, and set up 12 weeks of PT for patient. Patient has had to go to PT to help relieve pain, it has not stopped. x-ray was taken, reported as normal, and NP said no bursitis seen in x-ray (which is not possible) and said good luck with physical therapy. Patient then called an Orthopedic Surgeon office to get a shoulder ultrasound and diagnosis. Orthopedic diagnosed with bursitis and tendonitis and gave a steroid shot to help relive pain. Steroid shot helps so patient can at least get comfortable at night to sleep, patient not sleeping before steroid shot on Nov 3 due to immense pain.  Patient still in a lot of pain after steroid shot... ROM very limited, weakness present, and still painful.
Systemic: Fainting-Medium, Systemic: Seizure-Medium; symptoms lasted 0 days
in between these times she has been diagnosed with COVID-19/started to feel sick and had symptoms like cough and colds; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 10Apr2021 and stated her second dose is scheduled for Saturday (01May2021), however in between these times she has been diagnosed with COVID-19. On 18Apr2021, the patient started to feel sick and had symptoms like cough and colds. She tested positive for Covid- 19 on the 20Apr2021. The patient is asking if she can still go for her second dose or need to wait for a couple of weeks to take it. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
On Tuesday I still felt a little tired more than I should be and I had a dull headache which I thought was related to sinus pressure.  I also had a cough and my son came home and he was sick and tested positive for COVID-19 and was positive and the next day I still had a headache and I took a test and I was negative.  I was also having a sore throat and on Wednesday I was feeling horrible and had congestion and felt feverish.  On Thursday I went to the ED on the island to seek treatment and because I took a home test of COVID-19 and it was positive.  I took a picture and showed them at the ED that I was positive and they did not do another test.  They sent me home with a 5 day prescription with Erythromycin and Paxlovid and Tesla Pearls for my cough.   I was still having a headache the next day.  Today I feel like a whole brand new person with no symptoms.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Rebound; (Jun2022) Negative, notes: then tested negative for 2 days using at home tests; (Jun2022) positive, notes: then tested positive again on 4th day after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for 5 days for the treatment of COVID-19, then tested negative for 2 days using at home tests, then tested positive again on 4th day after completing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse referring to a male patient of unknown age. On 01-JUN-2016 at 9:30 during the same office visit the patient was vaccinated with GARDASIL 9 (intramuscular; strength, lot# dosage and frequency unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), TDAP (strength, lot#, dosage, frequency and route unspecified) and MENACTRA (strength, lot# dosage, frequency and route unspecified). The nurse reported that by 19:00 on the same day, the patient experienced feeling hot, vomiting, eyes rolling back and light headed. The nurse reported that the patient sought medical attention at the emergency room, but was no admitted. The nurse reported that treatment was prescribed by an unspecified provider described as on ZOFRAN intravenous push 4 mg for a one time dose during ER visit. In addition during the ER visit on 01-JUN-2016, a urine specimen was taken and blood was drawn, both of which specific test was unspecified. The nurse reported that the patient had recovered on 02-JUN-2016. The causality was not reported. Additional information has been requested.
This spontaneous report was received from a Licensed practical nurse regarding an unknown number of patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. On an 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, patients were vaccinated with improperly stored GARDASIL 9 with a lot number # L025737, expiry date: 28-JUL-2017 (dose number, dosing regimen, strength, anatomical location and route unknown) (incorrect product storage). Concomitant medications of the patient were unknown. No other adverse events were reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.