chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible flu like symptoms beginning the same night. Very restless sleep, terrible headache, terrible fatigue, severe body aches and aching joints. Fever, tummy ache first night all into wed. Thursday, I had terrible insomnia. Extreme panic attacks. Mild joint pain., fever..fatigue.  Starting  Friday I had  extreme fatigue, weakness in my legs that I can barely walk, restless twitching muscles, terrible nuerological symptoms. Extreme dizziness, can barely stand up. Headache, tremors, cognitive issues resembling slurred speech and seizure like activity, sensory issues, titanitus, hallucinations, angina, twitching lips. Twitching eyes, blurred vision, brain zaps, jumpy and still ongoing now on Sunday.
received 1st dose 4 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years ago in 2017 on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Pharmacist stated that, please advise if series needed to be repeated or second dose need to be administered as soon as possible. The reporter stated that, would not able to provide patient information as it was HIPAA related. The reporter consented to follow up via email.
This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old patient. On 29-JUL-2013 the patient was vaccinated with RECOMBIVAX HB (lot # not provided) (dose, route not provided) and PEDIARIX. No adverse effects reported. Additional information has been requested.
Patient presented with father for COVID vaccine, clinic staff asked if influenza vaccine was desired and father reported he would like patient vaccinated. Influenza vaccine was administered but after documentation staff noticed that patient had received flu vaccine on 10/4/2022 (at which time patient's mother had brought her to clinic); second dose should not have been given until 11/1/2022 (4 weeks between doses for 2-dose series). Clinic staff spoke with provider, who recommended to either administer another influenza vaccine in 4 weeks or to wait until next flu season to receive the 2-dose series.  Patient's parents currently considering whether to pursue a second immunization this season. No adverse outcomes reported after vaccinations given 10 days apart.
Long-term dizziness; Long-term imbalance; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Long-term dizziness) and BALANCE DISORDER (Long-term imbalance) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Long-term dizziness) and BALANCE DISORDER (Long-term imbalance). At the time of the report, DIZZINESS (Long-term dizziness) and BALANCE DISORDER (Long-term imbalance) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.
Slight fever of 99.6, extreme tiredness 3-4 days with continued tiredness for 2 weeks. Arm swollen  1 1/2 inches diameter at shot location for several days.
Patient had her face swollen approximately 12 hours after administration. No rash, no hives, no body itching, no shortness of breath, no red or swelling at injection site reported. The swelling has been responded well to Benadryl and has been improving. Patient was also prescribed Medrol Dose Pack from her doctor. We're not sure if the swelling is vaccine related since patient was fine with her first dose of Shingrix.
pt recvd vax & exp burning sensation in arm, x 5 mins; inject site was red, swollen & hot to touch; pain radiating from site up arm & down to elbow; itchy over upper body area; slept poorly; felt feverish; shoulder ached; edema;
Immediate onset of pain - states injection placed near top proximal humerus. "Felt like it went into the bone'. Has complaints now of pain with ROM, weakness with lifting above shoulder level or holding items up, also popping. Has used ibuprofen intermittently when pain is worse.
Left adhesive capsulitis following injection, left shoulder pain, unable to lift left arm x3 months
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient).  A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021.  Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course.  The case will be reassessed should additional information become available.  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.
Headache; neck pain; numbness into extremities; extreme pain in left arm; Extreme muscle pain in neck caused me to go to ER; Significant bilateral shoulder pain; Weakness; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 20Jan2021 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient is not pregnant at the time of report and at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose on 31Dec2020 on the left arm. On 20Jan2021 21:00, the patient's extreme muscle pain in neck caused her to go to the ER and tramadol and Norflex were administered. The patient had significant bilateral shoulder pain and weakness. The head and muscle pain in neck persisted. Events resulted in emergency room/department or urgent care. Treatment received were tramadol and Norflex. On 20Jan2021 22:00, the patient experienced headache, neck pain, numbness into extremities, and extreme pain in left arm. The events resulted in emergency room/department or urgent care. Tramadol was received as treatment but it worsened the symptoms. The tramadol was administered on the left arm at the hospital. Outcome of the events "extreme muscle pain in neck", "significant bilateral shoulder pain", and "weakness" was unknown and of the other events was not recovered.  Information about lot/batch number has been requested.
arm hurt; This is a spontaneous report from a contactable consumer, the patient. This 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899, Expiration date: 31Mar2021), first dose, via an unspecified route of administration in the left arm on 28Dec2020 at 09:30 (at 72-years-old) as a single dose for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included famotidine (FAMOTIDINE), tiotropium bromide (SPIRIVA), latanoprost (LATANOPROST), timolol (TIMOLOL) and loratadine (LORATADINE). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced arm hurt. The event did not require a visit to physician or ER. The outcome of the event arm hurt was resolved on 29Dec2020.
My daughter got lupus after the Gardasil vaccine.; This spontaneous report was received from an other healthcare professional and a patient's mother via Pfizer and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis.  On an unspecified date, after the vaccination, she got lupus. The outcome of the event was not reported.  The causality between the event of lupus and the suspect vaccine was not provided.  Upon internal review, the event of lupus was determined to be medically significant.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Miscarriage.  went to Emergency Room.  11/25/09 OB notes for DOS 11/17/09.  DX: Miscarriage  On 11/16/09, Pt developed vaginal bleeding, cramping and contractions. Pt admitted to ED and a transvaginal ultrasound was done.  On 11/17/09 Pt was seen by her OB. Pt miscarried on 11/19/09.
Red, itchy, burning rash developed at injection site and on  left side of chest/collar bone area. I was given 40mg a day of steroids with  no relief and Hydroxyzine HCL to help with itchiness, which did help. A week later it spread to the top of my  forearm, across my chest to my other arm. After another week it spread up my neck, on my back, stomach and legs. Given steroid injection and higher dose of steroids, 60mg a day. Still no relief. Then given topical cream Triamcinolone Acetonide 0.1% and still have yet to see any improvement.
Assessment Note on 4/27/2021:  I reviewed her case with Dr  regarding the possible interaction of Botox and Moderna vaccine. It appears the vaccine may have inactivated the Botox in certain muscles and not affected others. I asked her to call the call center and the CDC call center regarding this issue. She will try topical Voltaren Gel or Lidoderm that she has. I answered her questions and reviewed the plan. 1. Spasmodic torticollis  2. Dystonia  Right cervical, upper back, and shoulder area.
I had atrial fibrillation that was caused by  an overactive thyroid in February 2021.  I had a complete check up  and a CBC done in February and my WBC and Lymphocytes count were normal/in range.  I had a CBC done again on April 13th a couple of days after receiving my vaccine shot on April 9th and my WBC and Lymphocytes were normal/in range.  I had a CBC done again on May 12th approximately four weeks after my vaccine shot and my WBC and Lymphocytes were elevated/out of range.  I had a CBC done on July 13th and my WBC and Lymphocytes were elevated even higher.  I had a CBC done again on November 19th and my WBC and Lymphocytes were elevated to the point where my endocrinologist referred me to an Oncologist.  Oncologist did multiple blood tests and called me in for a consultation.  He informed me that I had Chronic Lymphocytic Leukemia and that there is currently no cure.  Before the vaccine  my blood counts were normal and shortly after receiving the vaccine they started to elevate and within a 6 month period I was being told that I had cancer.  I have no family history of any type of cancer.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 21-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Itching on top of mouth, globus sensation, tightening of throat, coughing  Epi 0.3mg IM given right delt at 0915.
Started pretty immediately with feeling overheated like a wave of heat then started feeling unwell or not right then my right hand went numb that was about five minutes after the shot. Told the nurses they took me back in a room took my vitals at that time I started to feel weak like my arms and legs were Jell-O or jelly. I also felt jittery the nurses gave me apple juice and crackers they put me in a private room they check my vitals again my heart rate was elevated and my blood pressure also went up . 02 That?s normalsats normal My feet are they just started to feel numb as well. A doctor came in and checked me out they felt like my exam was normal but they also felt like I might be having a mild reaction around 1500 I started to get itchy but no hives noted I took a Benadryl 25 mg at 1500 around 1515 my feet were still numb but I definitely felt better still kind of felt like my arms and legs were weak but not as bad so after an hour and a half I was allowed to leave and was told to rest for the rest The day and you call or go to the emergency room if I had trouble some side-effects about four hours after the shot  my lips did start tingling at home I did check my oxygen saturations and it was normal I look at my lips to make sure that they weren?t swelling the only thing I noticed was that a scar I have on my lip that usually you can?t see was more prominent and you could actually see it my lower back hurts a lot
Pins and needles immediately after injection in arm, days later still have pins and needles in left arm/hand/fingers
Patient became lightheaded, weak and clammy following the administration of all three immunizations. I laid her back on the exam table and put her bent her knees up. Water given and cool cloths applied to head and neck. Father brought into exam room. Sat patient up in a reclined position on exam room table. She did have one episode of emesis. Monitored patient for 20 minutes and allowed her to rest. Fan placed near patient to create a breeze. Patient and father informed me she has had a similar event in the past. Patient had not eaten anything yet for the day. Once patient was feeling better she was sent home with father to continue to monitor and to get something to eat. Patient was walking freely and conversing.
Patient mistakenly received the Pfizer COVID Vaccine at age 15, during a time when it was only approved for 16+. Following CDC guidance, the second dose was administered as well. No adverse effects reported.
Coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: F85682), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Cholesterol" (unspecified if ongoing), notes: Cholesterol. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol; AMLODIPINE taken for blood pressure measurement. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Coughing". Therapeutic measures were taken as a result of cough.  Additional Information: Reporter stated he took the shot about a week and half ago of Pfizer and ever since then he is been coughing. Report it, like it could become one of the side effects because they are studying in so that could be one of the side effects also. Reporter was informed about the role of Pfizer Drug Safety. When probed for gender: Reporter stated that I am reporting for my husband. Vaccination facility details was In Health Center. Reporter stated, All he has been taking is, I went to a pharmacy and I told them, she wanted him to take Zyrtec. So once he start taking the Zyrtec he start coughing more so he stopped taking the Zyrtec. He kind of like take Benadryl so he can sleep and he has taken couple of cough drops. He stopped taking the Zyrtec.
Bad itchy; red rash on hands and arms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176), via an unspecified route of administration on 22May2021 at 12:45 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced bad itchy, red rash on hands and arms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events bad itchy, red rash on hands and arms were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Numbness in thighs, then spread to entire legs and feet and up to waist by that night.
TIREDNESS; HIVES A COUPLE ON HER BACK AND ONE ON HER  CHEST AND ONE ON HER NECK; HOT - 99 CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 (vaccination at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced hives a couple on her back and one on her chest and one on her neck. On 13-MAR-2021, the subject experienced hot - 99 chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives a couple on her back and one on her chest and one on her neck, fever, hot - 99 chills, headache, and tiredness. This report was non-serious.
Fatigue High fever over 102* Mild confusion/dizzy Body aches Nausea Diarrhea Extreme pain at injection site  Symptoms for 48hrs Bed rest, ibuprofen and tylenol alternating
Patient returned to pharmacy on 10/17/13 at 12PM and indicated that she had swelling on the arm and a headache that had not gone away as of this time. Patient referred to PCP if swelling worsens or headache does not subside.
HPV #1 administered. Pt was seated. Pt got up. After standing pt fell, passed out, backward onto carpeted floor. Regained consciousness within 1'. No obvious signs of trauma. Kept pt supine x 10 min. Check blood pressure, gave juice and cold compress.
MAR 7 SHOT SITE RED & RAISED 1/4 DIAMETER & RIGHT HAND- BRUISES MAR 8 2 DEGREE FEVER, CHILLS, INSIDE MOUTH/ LEFT SIDE AREA BETWEEN CHEEK & GUM- CANKERSORE!  MAR 11 ADDITONAL HIVES- Left inner thigh & back of right index finger & hand @ base of right index finger
Blood clot that turned into DVT and PE on 09/24/2021 was admitted into hospital for 2 days. Blood thinniers -Eloquis. Lost of wages. Emotional, mental, physical duress and angusih due to the configuration of my leg. I will never be normal again.
After receiving the vaccine, the patient developed a hard quarter sized bump above the injection site. Ice applied to site. No bruising, bleeding, pain, or redness noticed.
Patient states woke 6:30 AM 07/23/08 itching all over, rash on back. Reported to medical center at 10:37 AM with red raised itchy papular areas, resolving after DECADRON 8mg IM given X 30-40 minutes.
42 year old male who on 08/11/2005 was vaccinated intramuscularly in the left deltoid with a 1 ml dose of Hepatitis B virus vaccine.  On 08/15/2005 the patient experienced soreness and weakness in the left arm and wrist and each has remained to the present.  The patient is not recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.