chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-03-22-2021-severe pain in right nostril. inability to make facial expressions without pain due to location of sinus pain. -08-28-2021 awoke in middle of night, severe pain in lower back.  lvl 10 pain- ER VISIT  -09-20-2021 awoke in middle of night, severe pain in left shoulder. lvl 10 pain- ER VISIT. Shoulder "locked" unable to move it. -11-20-2021 stood out of bed, unable to walk. severe pain in right achilles. ER VISIT/Dr Visit  -01-15-2022 awoke in middle of night, sever pain in right wrist/hand. lvl 10 pain ER VISIT. Hand was "locked" unable to move it.
This spontaneous report as received from a physician via Company Representative refers to a 12 year old male patient. In October 2013, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number not reported). No concomitant medication, pertinent medical history or drug allergies were reported. After receiving the second dose of the GARDASIL the patient experienced multiple seizures (date unspecified). In March 2014, the physician learned that the patient experienced atypical seizures with no loss of consciousness that would go longer than normal (onset date: 25-MAR-2014). The patient was admitted to the hospital on 25-Mar-2014 to 17-APR-2014 and had to be intubated (unknown date in 2014). It was reported that hospitalization was prolonged due to the event. During the time in hospital (unspecified days) the patient was in coma for 2 days and was also in the ICU (Intensive Care Unit) for 2 weeks. During the hospital stay, the patient had unspecified labs performed and the results were negative. The patient was prescribed an acyclovir and other unspecified antibiotics and medications to control seizures. The patient was currently seeing a neurologist. Therapy with GARDASIL was withdrawn, third dose would not be given. The patient's outcome was unknown. Causality assessment was not reported. Upon internal review the events of multiple seizures, atypical seizures with no loss of consciousness, intubation and coma were considered as medically significant. Additional information has been requested.
powder with a diluent solution. Not the one that goes with menveo; powder with a diluent solution. Not the one that goes with menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Menveo powder with a diluent solution. Not the one that goes with Menveo which led to wrong solution used during drug reconstitution and inappropriate dose of vaccine administered. This case is linked to the case US2021AMR170516, reported by the same reporter for different patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170516:Same reporter
The second shot I felt right away. It was painful.  Right away I felt it in the back of my head/neck.  I felt tingling in my arm down to my fingers. only on my left side where shot was given.  Arm was not as sore as first shot though..Later that night about 12 hours later I began to have a severe migraine in the back of my head/neck.  it made me extremely nauseaus.. I vomited a few time through out the night.  I used a heating pad on my head.. covered my eyes.. I could not speak loudly as my head hurt so badly.  I could not eat or drink as I would just throw it back up.  after 24 hours total, the pain went to the left side of my sinuses into my left ear. felt like I had a severe ear ache.  Nausea started to subside a bit. I managed to eat a few spoon fulls of white plain rice and a few sips of water.  Also, the left side of my face felt numb.   it still feels numb (tuesday morning)  but not as intense.   Headache and ear ache are gone. I am extremely tired.  I slept all day yesterday...Back of neck is sore.. but thank God no extreme pain.  I feel very fatigured.  stomach still doesnt want any food, drank 1/2 glass of water today.  injection site did not swell or feel too sore... Just that horrible headache. earache. numbness,, Felt dizzy. could not get up and had to have kids bring me water or a bowl to be sick in
At 1040, patient reported feeling light-headed and nauseous. We assisted her to a wheelchair and took her to a private area. We assisted her in to a recliner. VS at 1040 were BP 164/76, P 110, RR 22 and O2 97%. Denied breathing difficulties, itching, swelling, or HA. Had patient remove mask and gave her water to drink. Declined Benadryl. Second set of VS at 1100 were BP145/70, P 85, RR 16, and O2 99%. Patient reports she feels like the symptoms were related to hot flashes that she has been experiencing for a number of years. At 1115, patient reported she felt better. I walked with the patient to the exit where her husband picked her up to drive her home.
This spontaneous report as received from a nurse via a representative refers to a male patient of unknown age. On 01-MAY-2013 the patient was vaccinated with the first dose of ROTATEQ by oral. On 18-JUL-2013 the patient was vaccinated with the second dose of ROTATEQ by oral. ON 28-AUG-2013 the patient was vaccinated with the third dose of ROTATEQ by oral. On 09-SEP-2013, the patient's mother took him to the nurse's office, said that he had no appetite and was "not being himself". On 12-SEP-2013, an ultrasound was performed and the patient was sent to the emergency room (ER) due to "intussusception". Patient received unspecified treatment. No surgery had to be performed. On unknown date in 2013, the patient had recovered from the events. Additional information is not expected.
Pt is a long-term resident at nursing home. She came to the hospital due to feeling unwell and has atrial fibrillation. She was found to be COVID positive on both antigen and PCR testing, but denies symptoms.
ACUTE RESPIRATORY FAILURE 1/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient has been dealing with Degenerative Arthritis but is concerned that after receiving the second dose of the vaccine, that the arthritis has gotten worse.
his father felt bad for a couple days; Didn't feel well; Similar type of reaction as far as lethargy and fatigue following the first three Covid-19 vaccines; Similar type of reaction as far as lethargy and fatigue following the first three Covid-19 vaccines; Father laid around a little more and was less active; This is a spontaneous report received from contactable reporter (Consumer (patient's son)).  An elderly male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes Diagnosed for possibly 5-10 years.; "Congestive heart failure", start date: Feb2021 (ongoing), notes: CHF; "TIA" (unspecified if ongoing), notes: had multiple TIA's in the past that have worn away at his cognitive ability; "Cardiac stent" (unspecified if ongoing), notes: Cardiac stent within the last 20 years; "Triple bypass" (unspecified if ongoing), notes: Triple bypass In 1998 or 1999; "pacemaker" (unspecified if ongoing), notes: installed 1.5-2 years ago; "Pain" (unspecified if ongoing); "bowel regularity" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to receiving any vaccines; was hospitalized and previously in rehab from that Covid infection; "worn away at his cognitive ability" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; OMEPRAZOLE; METFORMIN; FUROSEMIDE; METHYL SALICYLATE; FERROUS SULFATE; BISOPROLOL oral; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID] taken for constipation; POTASSIUM CHLORIDE; LOSARTAN; ACETAMINOPHEN taken for pain; ATORVASTATIN; NITROGLYCERIN; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "his father felt bad for a couple days"; MALAISE (non-serious), outcome "unknown", described as "Didn't feel well"; LETHARGY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Similar type of reaction as far as lethargy and fatigue following the first three Covid-19 vaccines"; DECREASED ACTIVITY (non-serious), outcome "unknown", described as "Father laid around a little more and was less active". Additional information: For concomitant medication nitroglycerin, it was reported that the patient had a pacemaker installed 1.5-2 years ago and the patient rarely takes nitroglycerin anymore. Possibly over a year since he's taken it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201051311 same patient and different vaccine dose, different event separated in time;
Severe upper arm pain.  So severe i couldnt sleep the first night.  As the days have past the ache and occasional shooting pain  gradually reduced, and is now is just  located in the shoulder joint.  Joint pain has shut down the ability to raise my arm.  Its the 5th day after the shot and my sense is it will take another 5 to return to normal.  Arm pain can spike during sleep, waking me and i am awake for hours.
The following morning, overall muscle and joint aches. After 24 hours from the injection, a low grade fever; 99.9  I was hesitant to even report it, as I considered the adverse events not being a major concern. I really hope reports of adverse effects do not deter people from the Covid vaccines.  Even had I considered beforehand this minor effect, I would still get the vaccine. I probably should also note that this was my second dose. I had zero adverse events after the first.
Hx alblation in 2014 have not had menses since then. Post vaccine legs felt heavy and painful then got menses that lasted two or three days.  After second dose of vaccine, she had massive amounts of pelvic and leg pain, she bled for a couple of days, this was 2-3 days after the shot.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-NOV-2014, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles. As a direct result of this vaccine, on 31-DEC-2015, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. As a direct result of the vaccine, the patient suffered mental and emotional distress resulting in physical limitations and seriousness of her condition. As a result of the manufacture, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harms as a direct result of the use of ZOSTAVAX. The lawyer considered shingles outbreak to be disabling. Additional information has been requested.
Pt has red bumps around inject site and sore arm day after inject and is still having pain in arm for over 1 week.
RESTLESS SLEEP; This spontaneous report received from a parent concerned a 24 year old male. 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, batch number: Unknown, batch number: [043A71A], [043A21A] OR [043AZ1A] expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced restless sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restless sleep on APR-2021. This report was non-serious.
This case was reported by a consumer (the subject) and described the occurrence of muscle twitching in a 42-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included muscle "issues". Concurrent medications included SYNTHROID. On 15 July 2011 at 19:00 the subject received a dose of BOOSTRIX (.5 cc, unknown route, left arm) due to stepping on a nail. On an unspecified date in July 2011, within 2 to 3 days after vaccination with BOOSTRIX, the subject experienced muscle twitching. The muscle twitching started in her index finger and at the time of reporting was occurring between where her torso and leg meets, right foot, left shoulder and right thigh. The subject reported that her finger bothers her most during the day, but when she lies down at night she notices the other areas within her body. At the time of reporting the event was worse.
Within 30 minutes of the vaccine my head and neck started to itch. There were no hives, just itching. This was on and off for 2 days. The day after the vaccine my arm was swollen at injection site and lymph nodes of right arm were swollen and painful. 2 days ofter the vaccine I began having a pins and needles feeling in feet/legs. Mainly the left leg from knee down. This progressed over the next 10 days spreading to my hands and arms. 4 days after the vaccine my left leg from the knee down felt like a muscular issue was happening because it appears partially numb. My limbs repeatedly go numb while sleeping which has never been an issue until after the vaccine. I've had a burning sensation in different parts of my body that come and go including my head, neck and arms. I am having vision changes that go from eye to eye depending on the day. 8 days after the vaccine I had a reaction of hives on my neck (which I've never had before) and some breathing issues. 14 days after the vaccine this reaction happened again. It went away within 2 hours without medication. All of these symptoms are post vaccine and issues that I've never had before getting the vaccine. I am now 15 days post vaccine and have been to the ER twice. I've had an MRI scan on my brain and nothing other than a sinus infection was found. Blood tests were standard.
DID NOT TAKE VIVOTIF DOSES ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-2227) was received from a caregiver (consumer's wife) on 30-Aug-2019. It described a male consumer who "did not take Vivotif doses according to schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took Vivotif doses on day 1, 4, 6, and 8. The consumer took Vivotif 3 weeks ago from the date of report.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take Vivotif doses according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif doses according to schedule" was considered as not applicable.
Malaise, fever, lethargy, reduced appetite, weakness, dizziness, cough, rhinitis.
severe pain in her right arm after receiving PNEUMOVAX 23; Information has been received from a 67 year-old female consumer with no pertinent medical history and with allergy to aspirin reporting on herself. Her concomitant medications included ranitidine and pantoprazole 40 mg.  On approximately 13-JUN-2013 (reported as two weeks ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot number and expiration date were not provided).  It was reported that, on 13-JUN-2013 (two weeks ago), the patient experienced severe pain in her right arm after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No treatment for the pain was reported. No lab test were performed. The patient sought a medical attention by a phone call to her doctor. At the time of the report, the patient was recovering from the pain in her arm.  The causality assessment between the event and the suspect vaccine was not provided.  Follow up information has been received from the female patient on 03-MAR-2014.  She stated that the pain in her right arm was so severe that she could not go to a hospital. It was the next morning that she called the doctor but she would not go to his office. The patient stated that it took days to raise her arm again. She stated that the doctor may not have anything much on record (if at all) to he of help. The reporter considered the event of pain in her right arm to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23); reported as "caused" from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Follow-up information was received from the patient on 30-MAR-2021. It has been verified that the patient was 66-year-old at the time of the reaction. Her previous drug reactions included allergy to naproxen sodium (ALEVE). It was reported that the patient had no concomitant medications (previously reported as ranitidine and pantoprazole). The patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on approximately 13-JUN-2013, around 9 AM (also reported as on an unspecified date in 2014 - conflicting information as initial report was received on 27-JUN-2013). On the same day, around 5 PM, the patient experienced severe pain in her right arm. The patient sought medical attention and spoke to the office, however she did not receive any treatment for the event. It was also reported that the patient was not hospitalized due to this event. On approximately 15-JUN-2020 (reported as 2 days after the vaccination), the patient recovered from the event.
Nausea; cold sweat; This is a spontaneous report from a contactable consumer (patient). This 25-year-old male consumer reported that he received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via intramuscular route of administration in left arm on 01Feb2021 at 14:35 (at the age of 25-year-old), as unknown, single dose for COVID-19 immunization. Medical history included gallbladder removed about 5 years ago and covid around Dec2020 to an unknown date. Family Medical History Relevant to AE includes his mom was allergic to penicillin. There were no concomitant medications. It was mentioned that the patient did not receive any other products and had no investigation assessment. There was none additional vaccines administered on same date of the pfizer suspect. Adverse event prior vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. On 01Feb2021, 10 minutes after receiving the injection patient reported that he had nausea for about 40 minutes and said that he broke into a cold sweat when he got nauseated and when that cold sweat subsided, he started to feel better. He stated that the cold sweat only lasted about 1-2 minutes. The patient mentioned that he rarely gets sick. The patient did not require emergency room or physician office visit. He said that the last time he went to the doctor was when he had his gallbladder removed about 5 years ago. There were none relevant tests. The events recovered on the same day (01Feb2021).   Follow-up attempts were completed. No further information was expected.
numbness and tingling in the tip of her tongue / bottom of her lip while eating food; tingling in the tip of her tongue / bottom of her lip while eating food; "bump" that was irritated and red on the top lip; other side of her lip started swelling / last day of the prednisone, overnight her lips "blew up"; red on the top lip.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness and tingling in the tip of her tongue / bottom of her lip while eating food), PARAESTHESIA ORAL (tingling in the tip of her tongue / bottom of her lip while eating food), LIP DISORDER ("bump" that was irritated and red on the top lip), LIP SWELLING (other side of her lip started swelling / last day of the prednisone, overnight her lips "blew up") and LIP ERYTHEMA (red on the top lip.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced LIP DISORDER ("bump" that was irritated and red on the top lip), LIP SWELLING (other side of her lip started swelling / last day of the prednisone, overnight her lips "blew up") and LIP ERYTHEMA (red on the top lip.). On an unknown date, the patient experienced HYPOAESTHESIA ORAL (numbness and tingling in the tip of her tongue / bottom of her lip while eating food) and PARAESTHESIA ORAL (tingling in the tip of her tongue / bottom of her lip while eating food). At the time of the report, HYPOAESTHESIA ORAL (numbness and tingling in the tip of her tongue / bottom of her lip while eating food), PARAESTHESIA ORAL (tingling in the tip of her tongue / bottom of her lip while eating food), LIP DISORDER ("bump" that was irritated and red on the top lip), LIP SWELLING (other side of her lip started swelling / last day of the prednisone, overnight her lips "blew up") and LIP ERYTHEMA (red on the top lip.) outcome was unknown. Not Provided      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.
Swelling Rt arm at area of injection site, started that pm & progressed.  Swelling was at shoulder to elbow area.  Area was red & swollen.  Went to hospital was told it was a cellulitis infection, given IV antibiotics & told to report the incident.  Reported to this office 7/31/08.
About a week after my second dose of Moderna, I began to have pain in my right shoulder. The only way I could get relief was if I put my arm above my head, and I had to do the same as I slept. I had the same issue with my left shoulder after I got my first dose of Moderna a month prior. At the time of this writing, the problem persists in both shoulders, though it is more severe in the left shoulder.
I thought I was getting shingles again; I had a telephone consult with my primary care physician. He prescribed a large dose of an antibiotic to help with the rash. I took it for a week, but it had not impact on the rash. I went back into my doctor for him to look at the rash, he referred me to dermatologist. The dermatologist first put me Methotrexate, it was not effective, I went back in and was started on Skyrizi. I have had two injections and it has started to help. I will have my next injection in six months. The rash does cover different parts of my body head to foot. It has also affected my eyes where I am getting too much air into my eyes and feels like sandpaper rubbing my eyes. I am working with an ophthalmologist to resolve this issue.
pt recv vax & 7 days later devel 8x11cm erythema inferior to 10x14cm indurated area;recommended ice & NSAID
Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and congestion