chrisvoncsefalvay/vaers-outcomes huggingface dataset:
See letter & 3 exhibits here to attached. Enclosed please find a completed vaccines adverse event report, and attached "Exhibit A", "Exhibit B" and Exhibit C". This report and attachments describes the adverse medical problems that I have experienced as a result of a TDAP vaccine shot, which I received on August 10, 2010. I was an active person, who walked, outdoors, at least 5 days a week and was employed, for 26 years, as a paralegal. I retired, from that position, on August 1, 2010. My husband and I were anticipating a trip to celebrate my retirement. Regretfully, our trip did not occur, because of the severe medical problems, I experienced after administration of the TDAP shot. During my routine semi-annual office examination, on August 5th, a physician said that I needed a Tetanus booster shot. She said that her office was expecting a supply of the TDAP vaccine, which included Tetanus vaccine, and that I should call, and schedule an appointment for that shot. Following her directions, I called the following week, and received the TDAP vaccine on August 10, 2010. Several days after that shot, I began to feel ill. Thus I began a series of appointments with the Dr. and her nurse practitioner. At each visit, my symptoms increased. I experienced general lethargy, sore throat, ear pain, severe joint pain, swelling in hands and feet, low grade fever, lost weight, and difficulty in sleeping, walking, and eating. Each day was a nightmare. Various medications were prescribed, but nothing helped. During the September 13th appointment, Dr. contacted another doctor, of an arthritis clinic and made an appointment for me to see Dr. on September 15, 2010. Dr. ordered multiple blood tests and x-rays, and concluded that I have Sero-Negative Inflammatory Arthritis. When questioned, Dr. mentioned that vaccines, as well as other factors, could be a possible cause of my condition. Since my initial office visit, on September 15th, I have had regular visits with Dr., and it appears that I will need long standing treatment, for this illness. When consulting the Center for Disease Control & Prevention's web site, I discovered that in Section C-H, it stated that the TDAP vaccine is not licensed for use in adults aged 65 years. Please advise me regarding the safety of the specific vaccine I received. This could be helpful in determining what course of treatment, if any, could be undertaken, to help resolve my medical situation. Also asvise me if the administration, of TDAP vaccine, has produced a medical condition, such as I have experienced, or if it could otherwise adversely affect the health of other persons, including those 65 years or older.
Narrative:  COVID infection following COVID vaccine series 03/08 COVID vaccine dose #1 03/29 COVID vaccine dose #2 11/03 COVID vaccine dose #3 12/18 pt reported close exposure to person with COVID, COVID positive, no symptoms
Stroke; Vision loss; Blurry vision; Nausea; Vomiting; Headaches; Confusion; Memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 (Lot number: E1614) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: medical history: High blood pressure; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR; BUSPIRONE; ZOLOFT; LISINOPRIL/HCTZ. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, Medically Significant) with onset 15Jan2022, outcome "not recovered", described as "Stroke"; BLINDNESS (hospitalization, disability, Medically Significant) with onset 15Jan2022, outcome "not recovered", described as "Vision loss"; VISION BLURRED (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Blurry vision"; NAUSEA (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Nausea"; VOMITING (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Vomiting"; HEADACHE (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Headaches"; CONFUSIONAL STATE (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Confusion"; AMNESIA (hospitalization, disability) with onset 15Jan2022, outcome "not recovered", described as "Memory loss". The patient was hospitalized for cerebrovascular accident, blindness, vision blurred, nausea, vomiting, headache, confusional state, amnesia (hospitalization duration: 5 day(s)). The events "stroke", "vision loss", "blurry vision", "nausea", "vomiting", "headaches", "confusion" and "memory loss" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of cerebrovascular accident, blindness, vision blurred, nausea, vomiting, headache, confusional state, amnesia.
pt woke up 3AM;pt states was very sick to stomach & dizzy;pt stated if had anything on stomach, would have gotten sick about 5x that day;took 2-3 days a/felt better;
Pt began feeling short of breath and feverish the night after receiving vaccine, which worsened to right-sided chest pain w/ inspiration that radiated to his back. Pt returned to work 03/01/2021 then checked into urgent care the following day d/t worsening symptoms. Patient Plan written by PAC: "At this time the nature of your pain is not clear. Your cardiac enzymes are within normal limits except for myoglobin which often goes up with skeletal muscle pain. Your BNP test which can come up with congestive heart failure is elevated slightly from your normal.  We will want to recheck this in a week or so. Differential diagnoses could be skeletal muscle pain/injury, herpes zoster or shingles. (This can sometimes have sharp nerve type pain that will develop into a rash within the first 7 days.) Your rapid COVID test was negative.  We are sending a PCR test out just to confirm.  While awaiting test results please isolate at home. We will call you soon as results are back. Refer to Mendocino County's packet/isolation order. Your potassium level is low at 3.2.  It should be 3.6. We gave you some potassium to take in the clinic.  I am going to give you some to take for an additional few days. When you follow-up next week plan to have your labs redrawn." Plan Orders: SARS-CoV-2 RNA (COVID-19), QUALITATIVE NAAT to be performed. URIC ACID to be performed. The patient had the following medication order(s) completed today: Potassium Chloride 40meq PO; Toradol 15mg IVP.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 07-JUN-2017, the patient was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2017, "shortly after" receiving ZOSTAVAX, the patient experienced acute retinal hemorrhage on her right eye and shingles under her breasts and back. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. The outcome of the events was considered as not recovered. The events were considered to be related to ZOSTAVAX. Upon internal review acute retinal hemorrhage was considered to be medically significant.  Additional information has been requested.
Left deltoid: red, swollen and warm to touch.  Redness area is larger than a golf ball.  Painful.
patient felt dizziness after the vaccine stayed in the store for over 20min for observation. She said she felt fine and went home. She called stating that a few hours after leaving the pharmacy she felt difficulty breathing and chest pain. I informed patient to see a doctor to have her symptoms evaluated by a doctor. she stated she would go to the er after getting off the phone with me but it is unknown if she actually went. Tried calling patient to follow up no answer.
After shot, started getting muscle spasms in entire body and muscle aches, bad headache, fever of 100.8 . Started the same night as the vaccine was given, worse the next day.
Pt experience b/l hand tingling and then sob after getting vaccine, approx 10 min later.  Improved after 25mg benadryl, called ems and taken to ER for ekg and observation.
Sweats, body shakes, vomiting, muscle pain, and tightness in throat starting at 9:00pm on 8/7/23 that lasted for about 5 hours per patient. Patient did not seek medical attention and is feeling fine right now.
5 X 5cm redness to left thigh with minor swelling, hot to touch. C/o pain with palpation. Ancef 125mg IV q8h. Solu-Medrol 9mg IV q6h. 01/05/07-records received and reviewed for DOS 09/23-09/24/06 DC Summary:  DC DX:left thigh cellulitis secondary to immunization, mild metabolic acidosis. 24 hour stay treated with IV steroids and IV antibiotics. Afebrile during hospital stay.
If it has been 2 months since my first dose, can I get the second dose?; 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 PRODUCT DOSE OMISSION ISSUE (If it has been 2 months since my first dose, can I get the second dose?) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (If it has been 2 months since my first dose, can I get the second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (If it has been 2 months since my first dose, can I get the second dose?) had resolved.            No concomitant medications and no treatment medications were provided .   Reporter did not allow further contact
Employee received flu vaccine at 14:20 and returned back to her area to work.  At around 15:00, she returned to the nurse - stated that she did not feel well - felt dizzy, nauseated, and hot.  Employee's skin is reddened with a fine rash noted to face, arms, legs, and trunk area.  Employee laid down and dizziness subsided. But redness and hotness did not.  No progression of symptoms - denied SOB, tongue, lip, or throat swelling and denied any difficulty breathing. Area around injection site is really red and warm to touch.  Remains with redness and fine rash covering her body.  Employee had Benadryl and took 50 mg po Benadryl.  Within 30 minutes of taking the Benadryl - redness, rash, and flushing all resolved - including around the injection site.  Employee states dizziness and nausea have also subsided.  Employee monitored for an additional 2 hours with no return of symptoms.
injection site redness; injection site was a bit warm; swollen arm; felt like it had a hard lump; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced injection site redness, injection site was a bit warm, swollen arm and felt like it had a hard lump. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Both arms 4x swollen, red, warmth at site if flu and pneumovax right left site
pt reported having a rash on front and back of neck a couple days after the injection.  It was itchy, red, but no hives were reported.
(R) deltoid has a 3 x 4 cm red, hot, hard lump. Increased temp 104.
pt describes mild aches, chills and cannot sleep at night. Temp 38.0C. Pt received flu vaccine 11/22/04 in afternoon. Symptoms began late that night. Sent home form work 11/23/04 to rest.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthmatic" (unspecified if ongoing); "Known allergies: sesame" (unspecified if ongoing), notes: Known allergies: sesame; "Known allergies:  nuts" (unspecified if ongoing), notes: Known allergies:  nuts. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2weeks was reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3/3/23 I had a sore throat, headache, cough, nasal congestion, achy all over which lasted for several days. The cough got deeper and more productive. On 3/6/23 I went to the urgent care, and I was prescribed benzonatate for my cough and I took TYLENOL for fever and aches. I tested negative with a COVID 19 PCR test. I was ill for 10 days.
7/19/19 - woke up with very sore Left arm, muscles across the back were very sore and stiff as will as back of neck 7/19/19 - mid day suddenly was very tired  and starting getting achey joints 7/19/19 - evening  still achey and very tired took some tylenol and went to bed 7/20/19 - middle of night 3AM woke up to go to bathroom and got a bad case of the chills, later on ran a fever  7/20/19 - Saturday felt weak and out of sorts all day and evening  - no energy 7/21/19 - Sunday 12:30AM woke up with a pounding headache.  took tylenol and put a ice pack on my head and 2 hours later it went away Sunday 7/21/19 - `10AM - woke up with no symptoms anymore and none since
Large red, raised itchy area surrounding injection site.   Lymph node in left armpit swollen and painful.
Mother described sons rt thigh was very tender to touch, son would cry, leg is swollen. He also had a fever.
Mild rash; Itchy; Red; A spontaneous report was received from a consumer concerning a 79-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild rash/vaccination site rash, itchy/vaccination site pruritus, red/vaccination site erythema.  The patient's medical history was not provided.  concomitant product use was not reported by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events,  mild rash, itchy, red. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), mild rash, itchy, red, seems to be going away was resolving.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the known safety profile of mRNA-1273.
he was weak; fever; chills; now has to use a walker; Nausea; throwing up; fell; This is a spontaneous report from a contactable consumer reported that. A 70s male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunizations. The patient medical history and concomitant medication was not reported. Patient had a lot of comorbidities and we dis not how he would react to it. He had Polychondritis, rheumatoid arthritis, diabetes. I did not know if it was worth the risk. He was on Xeljanz, autoimmune drug for this RA. Patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) for covid-19 immunizations. On an unspecified date when people get their second dose, they have horrible side effects of weak as a cat, fever and chills and now must use a walker, nausea, throwing up. Even his Physical Therapist he is in his 30s, he had terrible side effects after the 2nd round, and he was out for 3 days. The event outcome was Unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
12/23/2022 I had fever of 103 degrees, extreme fatigue, body aches and breathing difficulties. I did an at home COVID test which was negative. I went to the hospital because I could not breathe on 12/30/22. I was admitted. I was diagnosed with RSV and double pneumonia. I was tested for COVID which was negative. I was on IV antibiotics and morphine. I had shots of prednisone every day while in the hospital. I was on oxygen the whole time I was in the hospital. I was discharged on 1/4/2023 with oxygen because I had a low level but did not use it. I was also sent home on prednisone. It took about six weeks to recover.
So I  got the first dose of the Pfizer vaccine on Sunday.. I had horrible chest pressure and my eyelids and lips ended up swelling up a little but it resolved itself within an hour or so. Ever since my heart has been racing, just walking across the house my hr was 135. I've been feeling sob and tired. Having intermittent chest pain and pressure. My hands and feet have pins and needles and my blood pressure is 159/98 and I normally have perfect bp
Patient started experiencing upper respiratory symptoms (cough, shortness of breath) and weakness on ~ 8/22/21. His son brought him to the ER on 8/26/21 since patient started to wheeze and his symptoms were not improving with OTC medications. He was noted to be confused in the ER as well as hypoxic, and heated high flow oxygen was started due to respiratory failure. Pt was admitted to the hospital and was started on COVID treatment with remdesivir and dexamethasone since he tested positive for COVID in the ER on 8/26.  He is also receiving Eliquis 5 mg BID for suspected PE on CT (patient was on Eliquis 2.5 mg BID prior to admission for Afib). Pt is currently on day 5 of hospitalization (on 8/31) and is now on room air with good O2 saturation. Hospital discharge is anticipated to be soon.
10/9 3rd dose of rabies vaccine, this later, pain at injection site, next AM back pain. 10/10 fever 102.5 F malaise. 10/12 back pain. 10/13 felt well again.
Mother calls to report child had 2 hour episode of feeling like would pass out, reports vision closing in/blackening, several times. This occurred 8/14/16, child then went to bed and no further occurrence today.
Right after the shot, symptoms lasted for over an hour: Nausea, fatigue, dizziness, difficulty swallowing, numbness and tingling in the hand. Two days after the vaccine: loss of sensation in both legs (from the knees down) , constant nausea, fatigue and dizziness. Almost three weeks after the vaccine (today): constant fatigue and dizziness, nausea
PATIENT NOTICED BLOOD CLOT IN URINE 8-9 DAYS AFTER SECOND DOSE OF COVID VACINE GIVEN. BLOOD CLOT IN URINE OCCURRED ONLY ONCE AND CLEARED AFTERWARDS.NO OTHER SIGNIFICANT POSSIBLE ADVERSE REACTIONS NOTED BY PT
the child had a fever of 104 and vomiting the same night she received the vaccine.; the child had a fever of 104 and vomiting the same night she received the vaccine.; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who had a  fever of 104 (pyrexia) and vomiting the same night (vomiting) she received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 19-Sep-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5772BA and expiration date-17-Sep-2022] via intramuscular route in the left arm for prophylactic vaccination.  On same day, the patient had a fever of 104 (pyrexia) and vomiting the same night (vomiting) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Final diagnosis was pyrexia and vomiting.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for both events.
Missed a dose of Vivotif; Spontaneous report received on 23JUN2020.  A healthcare professional reported that a consumer who "missed a dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. The reporter stated that, the consumer had missed a dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer missed a dose of vivotif. Information on when the consumer started taking vivotif, and which number dose was missed was limited. Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer missed a dose of vivotif. Information on when the consumer started taking vivotif, and which number dose was missed was limited. Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to vivotif due to the nature of the event.
Had normal symptoms after 2nd vaccine (painful arm, flu like symptoms, small fever). Felt better after 36 hours Experienced a severe cold-like symptom starting 5/26/21 but it wiped me out worse that a cold. Felt like the flue but never developed a fever. Had cough, runny nose, body aches that lasted about 5 days.  Just as I was finally feeling better, I experienced severe pain on my upper right quadrant that traveled to my shoulder that started as uncomfortable feeling to I couldn't breathe through the pain. The pain was severe enough that I was unable to drive myself to hospital and had to call an ambulance at 2am in the morning and took me to ER. The pain lasted about 3 hours and at the ER an ultrasound was done that showed a had gallbladder stones. All my blood work appeared normal. I have not had gallbladder issues before. After researching the symptoms of this condition, i realized I may have been experienced the symptoms starting several weeks earlier (nausea, diarrhea, chills) which I had attributed to stress or the cold i was recuperating from.