chrisvoncsefalvay/vaers-outcomes huggingface dataset:
02:05 2022 Morning, months after my vaccine, I began to feel numbness creeping up from my feet to my lower leg, within a 24 hour period it was from my belly button down that I had numbness. There was no pain however there was a lack of sensation in my lower body. I set up an appointment with my Ortho specialist, they stated that after the exam there was nothing that seemed to be wrong, however he did give me a prescription for PT and I have been doing that since. I have been working with two PT specialists and at times I do feel a difference, however I still notice that it will come and go with the loss of sensation in my toes and lower leg. I have gone to the ER and I had blood work, lumbar and thoracic spine MRI and ruled out any issues. I am still currently feeling loss of sensation in my toes and lower legs at times that are worse. I have also felt in my upper torso area I have noticed a different sensation in my skin in my upper chest area and back as well. I was having difficulty with walking and balance due to severity of loss of sensations.
trouble breathing/shortness of breath; terrible headache; I had chest pains; This is spontaneous report from contactable consumer (patient). A 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW6H02, expiry date not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 17:00 as single dose for covid-19 immunization. The patient medical history included allergies to IVP dye (reported as "die").  Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medication included insulin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicillin, codeine, and atorvastatin (LIPITOR) and experienced allergies to them.  On 26Feb2021, the patient had chest pains, and on an unspecified date in 2021, had trouble breathing, terrible headache, and shortness of breath which lead to surgery. The events were reported as serious life-threatening and had caused hospitalization on unknown dates. It was reported that for the event chest pains the patient was hospitalized for 5 days, while for the other events it was not provided how many days the patient was hospitalized. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 on 20Mar2021 which was negative nasal swab. Therapeutic measures were taken as a result of the event shortness of breath which included surgery, and chest pains. The outcome of the event chest pains was recovering while the outcome of the other reported events was unknown.
Suspected vaccination failure; But still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles vaccines but still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Redness and swelling on left thigh 24 hours after vaccines. Was treated with Keflex. Improved after TX.
7/4 pt c/o eyes burning, dizziness and arm pain at inj site. Sites red and raised. Pt went to ER given antibiotics followed up here 7-6-07 given by Rocephin 1gm at office.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of placed in refrigerator was on 22-Sep-2021 and vaccine did not undergone any temperature excursion. Patient did not experience ant adverse event. No concomitant were reported. No treatment were reported.
This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 21 October 2008 the subject received a dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion, a drop in her blood sugar down to 46 and weakness.  She was taken to the emergency room.  Limited information was available.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.  The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office.  The medical doctor's office contacted the second distributor with the limited information.  It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room.  Linked case numbers include A0754328A and A0754338A.
Information has been received from a nurse concerning a male who on 25-SEP-2007 was vaccinated with one dose of MMR II (HSA) (lot# 652483/0148F). The nurse reported that the "last week", on approximately 20-APR-2009 the patient was diagnosed with measles. The patient was treated with immune globulin. The patient sought medical attention by an office visit. No further information is available.
Covid 19 break-through infection.  Treated with REgenCov due to risk factors for severe disease.
Patient returned to pharmacy on 9/14/16 did not report specific timeline when questioned.  She says her arm was swollen, then body felt hot, eyes hurt, had trouble walking and had back pain.  She felt like she had the flu. Patient stated she was going to ER.
Within an hour of injection body aches (including lower back) and swollen lymph nodes in throat noted. By Sunday 09/25/2016 pain remained in lower back. Morning of 09/26/2016 pain located in mid back on the right side. Felt like muscle spasm. Sharp pain on inhalation and when turning to the right. Treating with Ibuprofen and TYLENOL (rotating), ice/heat, Epsom salt bath, and chiropractic visit in the late afternoon of 09/28/2016. Still experiencing pain on the morning of 09/29/2016...visit to Employee Health MD. Will continue to monitor over weekend as MD feels the reaction should subside over time. Told to continue home treatment of Ibuprofen/TYLENOL/Ice/Heat.
Varicella vaccine given 7-22-11 on 7-29-11 presented with lesions on left humerus area and on right side of face no fever acting fine.
Patient had vaccine at 830am. She stated that she has a history of atrial fibrillation to the vaccine nurse. The patient was asked to stay for 30 minutes for monitoring as a result.  The nurse put a cardiac and automatic B/P on the patient due to her afib.  Vitals were stable. At about 8:50am, the patient stated she felt her heart flutter. She was moved to a recliner and legs elevated. at 8:55am, her vitals were: 164/94 HR 83 P02 99% & Resp 14, 9:02am BP 150/100 HR 80,P02 99 Resp 18. 9:09am BP 173/93, HR 90, p02 100 & Resp 26 Decision made to call rapid response RN. Patient started to breath very deeply and clutch her chest.  Nurse arrived . Patient stated that her throat was getting tight Assessed patient. Benadryl 25mg IV given @ 9:12am. Adult medical emergency called overhead. All team members arrived. Patient started on 2L O2 via nasal cannula. Patient transferred to Wheelchair and transferred to ED at approx 9:18am .Patient awake and alert at all times. Patient discharged from ED 9/14/2021
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In September 2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
She had to press hard to feel a little tenderness on the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection). At the time of the report, VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection) was resolving.            Patient was concerned whether she got the right dose as she barely did not feel any pain at all.  No relevant concomitant medications were reported. No treatment information was provided.
Rheumatoid arthritis; Joint pain; Fever; Hives; This is a solicited report from the Regulatory Authority by a non-contactable consumer (patient) based on information by Pfizer from the RA, Manufacturer control number: 21K-163-4080010-00.   A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 30Mar2021 (Batch/Lot number was not reported) at the age of 54-year-old as single dose for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe ulcerative colitis. Medical history included sulfa allergy. It was unknown if patient was enrolled in a covid-19 vaccine trial. There were no concomitant medications. The patient previously took amoxicillin;clavulanate potassium (AUGMENTAN) and lisinopril and experienced allergy. On 30Mar2021, the patient experienced possible rheumatoid arthritis and joint pain, fever within 24 hours of covid shot and hives within 24 hours of covid shot. The action taken in response to the events for adalimumab was unknown. Outcome of rheumatoid arthritis was unknown, of joint pain was not recovered, of other events was recovered in 2021.   The reporter's assessment of the causal relationship of the rheumatoid arthritis and joint pain with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event of possible rheumatoid arthritis was not provided. The reporter's causality for the events of joint pain, fever within 24 hours of covid shot and hives within 24 hours of covid shot with adalimumab was no reasonable possibility.  The reporter's causality for fever within 24 hours of covid shot and hives within 24 hours of covid shot with bnt162b2 was a reasonable possibility.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events, possible rheumatoid arthritis and joint pain, fever within 24 hours of covid shot and hives, and the administration of the COVID 19 vaccine, BNT162B2.   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 RA, as appropriate.
Moderna COVID 19 Vaccine EUA Vaccination day: some soreness and redness at injection site as expected by the end of the day.  Day after vaccination 1/14/21: very tired slept all day, injection site visibly larger and more red and raised. Day 3-10 (1/15-1/23): injection site grew and worsened. 4" x 2" red, hot to touch, raised. Continued to look worse and worse as days passed. Day 11 (1/24): raised red warm ring around the 4"x2" area and inside that ring the area was lighter and more pink than red Day 12 (1/25): injection site much less angry, less inflamed and no longer hot to touch, no more ring, pink area blending with skin and area no longer raised but if you feel her arm you can still feel the slightly hard area. Finally improving!
Day 1-3 Typical arm soreness, mouth burning, then both eyes burning. On 4th post vaccine woke up with severe face swelling with redness, Both eyes swollen shut. Face extremely hot to touch; could not bare light.  Continued to words slurring. November 5-7 right side of mouth slightly drooping. Since vaccine, Right Eye can barely open. Burning both eyes. Dry rash around eyes and face. Cannot tolerate any light source. Headaches started with 1 day of Vaccine. *** I started getting intermittent headaches since having COVID19 in March 2020; false negative.
Sore arm after 2nd shot; Very low fever after 2nd shot; Headache after 2nd shot; Fatigue after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 2nd shot), PYREXIA (Very low fever after 2nd shot), HEADACHE (Headache after 2nd shot) and FATIGUE (Fatigue after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after 2nd shot), PYREXIA (Very low fever after 2nd shot), HEADACHE (Headache after 2nd shot) and FATIGUE (Fatigue after 2nd shot). On 15-Mar-2021, PAIN IN EXTREMITY (Sore arm after 2nd shot), PYREXIA (Very low fever after 2nd shot), HEADACHE (Headache after 2nd shot) and FATIGUE (Fatigue after 2nd shot) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-372307, MOD-2021-372413 (Patient Link).
The day after I got my 2nd shot, I developed knots above my collarbone that you can literally move and grab.  It?s big. And my armpit is swollen but I kind of expected that.
tired/some fatigue; had what she voiced as a knot form on her arm/had a huge knot on her arm that was feverish; sluggish; looked like a golf ball under her arm it was red and warm to touch and painful.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Lot number: EL9265) at the age of 69 years as dose 2, single for covid-19 immunization.  Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: on a breast cancer drug trial and has been on it for 17 years. The patient was on a breast cancer drug trial and has been on it for 17 years. Breast cancer trial medicine: estriol 2mg-estradial 0.25mg, estrone 0.25mg, bhea 5mg, testosterone 0.75mg progesterone 200 mg. 200mg of progesterone, they can't put this in the other capsule so they have to make it as a separate capsule but it was all one medication. Concomitant medication(s) included: LEVOTHYROXINE SODIUM (ongoing); MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC (ongoing). Vaccination history included: Bnt162b2 (dose 1, single, lot EL1283, expiration date. unknown), administration date: 19Jan2021 on upper left arm, for Covid-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired/some fatigue"; NODULE (non-serious), outcome "unknown", described as "had what she voiced as a knot form on her arm/had a huge knot on her arm that was feverish"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish"; SKIN MASS (non-serious), outcome "unknown", described as "looked like a golf ball under her arm it was red and warm to touch and painful.".  Additional information: No investigation assessment was performed. After the patient got the second vaccine she was sluggish and had a huge knot on her arm that was feverish. The patient felt sluggish within a day or two after second vaccine. After the second vaccine the patient had what looked like a golf ball under her arm it was red and warm to touch and painful. The patient was really tired and that lasted a week or more and then it subsided after about 2 weeks, she was guessing.  Communication: PC filed. The patient was provided with USMI's phone number, option 3, and hours of operation of Monday through Friday 8AM to 8PM, 9 am to 3pm Saturday and Sunday, EST, prior to cold transfer due to a high call volume.  Description of Product Complaint: The patient tried one prescription, diphenoxylate atropine 2.5 mg tablets and it didn't do it, it would slow down the diarrhea but would not stop it. This medicine is in a pharmacy bottle, unknown lot, expiration date 15Feb22.
On second dose of vaccine given on 01/27/2021 at approximately 12:30pm during working hours. I began to feel chills throughout my body at approximately 3:30pm in the afternoon. It continued to intensify throughout the evening with chills and body aches.  Then I had taken my temperature at 11:30pm and my temp was 102.7*. I then took a Naproxen 500mg for the body aches and my fever broke about 2 hour later. On 01/28/2021 the fever returned again with chills and body ache. My temperature was 101.0* at 11:30am, at which time I took another Naproxen 500mg, for the body aches. Fever and chills are gone at this time, but now I have headaches. This is at 3:39pm on 1/28/2021.
He passed out; Injection site was bleeding; Learn about severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (He passed out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 LOSS OF CONSCIOUSNESS (He passed out) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (Injection site was bleeding) and HYPERSENSITIVITY (Learn about severe allergic reaction). At the time of the report, LOSS OF CONSCIOUSNESS (He passed out), VACCINATION SITE HAEMORRHAGE (Injection site was bleeding) and HYPERSENSITIVITY (Learn about severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A dose of VARIV AX was given after its expiration date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 14-FEB-2022, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, anatomical location and lot # were unknown) for prophylaxis. It was stated, that the vaccine expired on 23-JAN-2022 (expired product administered). The vaccine had not undergone temperature excursions. No additional information was provided.
Total disorientation, fatigue and not moving, used bathroom in bed peed and pooped on herself, chills, slight fever, extremely nausea, vomiting and 24 hours later diarrhea.
Information has been received from a healthcare worker concerning a 28 day old patient who on an unspecified date was vaccinated orally with the first 2.0 mL dose of ROTATEQ.  The patient had not experienced any known symptoms.  Additional information has been requested.