chrisvoncsefalvay/vaers-outcomes huggingface dataset:
spinal stenosis was worse; arthritis was worse; 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 SPINAL STENOSIS (spinal stenosis was worse) and ARTHRITIS (arthritis was worse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Spinal stenosis and Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SPINAL STENOSIS (spinal stenosis was worse) and ARTHRITIS (arthritis was worse). At the time of the report, SPINAL STENOSIS (spinal stenosis was worse) and ARTHRITIS (arthritis was worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Rash is getting worse; severe rash on lower right leg with blistering and swelling; burning sensation to the touch; burning sensation to the touch; severe rash on lower right leg with blistering and swelling; severe rash on lower right leg with blistering and swelling; extreme chills est 3hrs; body ache all over; nausea; This is a spontaneous report received a contactable consumer, the patient. A 63-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose via unspecified route in the left arm on 21Apr2021 at 10:15  (at 63-years-old) for COVID-19 immunisation. Relevant medical history included Diabetes and High Blood Pressure. Concomitant medications sans indications, posology and therapy dates included carvedilol; losartan potassium; and levothyroxine sodium. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER8735) in the left arm on 30Mar2021 at 11:45 (at 63-years-old). The patient denied any known allergies or any COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 21Apr2021 at 23:30, reported as twelve hours after receiving the vaccine, the patient began to experience extreme chills est 3 hrs, body aches all over, and nausea. On 22Apr2021 at 10:15, reported as twenty-four hours after receiving the vaccine, the patient developed a severe rash on lower right leg with blistering and swelling. The patient described the rash as going from ankle to knee, and no itchiness just a burning sensation to the touch. The patient reported that he had not yet sought medical attention though planned to go to the emergency room (ER) for the rash as it was getting worse. The patient denied any COVID testing since receiving the vaccine. It was reported unknown if any treatment was received. The outcome of the events extreme chills est 3 hrs, body aches all over, nausea, severe rash on lower right leg with blistering, burning sensation to the touch, and getting worse, was not recovered.
Patient has severe pain, redness, swelling  on the site of injection .Her arm is red about 8 cm diameter and swell up about an hour after the vaccine and continue until 10/5/23. Patient said she is in so much pain that she couldn't move her arm up the next day. We advise patient to take Motrin for pain/swelling and Benadryl for itchiness. We call and follow  up with her today 10/5/23. She is getting much better and has no questions.
Pt recvd Engerix-B on 1MAY90, 30MAY90, & 23OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
my 17 year old grand daughter was given Moderna vaccine in April; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old grand daughter was given Moderna vaccine in April) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old grand daughter was given Moderna vaccine in April). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my 17 year old grand daughter was given Moderna vaccine in April) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was provided.
C/O NAUSEA/VOMITING, STOMACH ACHE, COUGH, CHILLS. DEVELOPED SEVERE SORENESS AT INJECTION SITE BY 6:00AM. DENIES ERYTHEMA.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced administration of expired vaccine. On 04-OCT-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine, incorrect product storage and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049577, 20211049738 and 20211049203.
dry mouth; my mouth still hurts; my tongue burns; I get up in middle of night to use my biotine mouth sprays; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "I get up in middle of night to use my biotine mouth sprays"; DRY MOUTH (non-serious) with onset 2021, outcome "not recovered"; ORAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "my mouth still hurts"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "my tongue burns". The events "dry mouth", "my mouth still hurts", "my tongue burns" and "i get up in middle of night to use my biotine mouth sprays" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth, oral pain, tongue discomfort, sleep disorder.  Additional information: It was reported that after the patient's first or second dose, the patient started to get dry mouth and did not know if it was a side effect. She consulted her doctor. The doctor took blood work and everything was good. The patient consulted oral specialist for six weeks and found nothing. The patient reported that her mouth still hurt, her tongue burned. She got up in middle of night to use her biotine mouth sprays etc. The patient reported that she was 78 year old and it had lasted almost a year. The patient got Pfizer vaccines one and two also got two booster shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax; 6 hr of crying; T 102; leg swollen, not red;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: After 5 minutes patient stated that she is dizzy and her vision is blurry and going black. She then fainted and that was when the epi pen was given to the patient. She was unresponsive for a total of about 10 seconds. She was awake and responsive after the epi pen. She stated that she was still dizzy, but she did not have trouble breathing or swallowing. Patient states she had similar reaction when she had ears pierced and TB test. She was taken to hospital after by EMS.
The child was given 1 Tdap and 1 Flu imunizations in the morning and 1 Tdap and 1 Flu immunizations in the afternoon because of duplicate consents. The child did not verbalize that she received shots in the morning even though she was asked when was the last time she received shots.
Pain on one side of his head/headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pain on one side of his head/headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Pain on one side of his head/headache). At the time of the report, HEADACHE (Pain on one side of his head/headache) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-073535 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073535:Original Case : MOD-2021-073535 (First dose case)
pain in her right leg starting with knee and passed through the ankle; arm pain; she hasn't received the 2nd shot yet; swollen injection site; whole arm hurt (site of injection); arm has a red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (arm has a red rash), PAIN IN EXTREMITY (pain in her right leg starting with knee and passed through the ankle), PAIN IN EXTREMITY (arm pain), PRODUCT DOSE OMISSION ISSUE (she hasn't received the 2nd shot yet) and VACCINATION SITE SWELLING (swollen injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH ERYTHEMATOUS (arm has a red rash), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PAIN (whole arm hurt (site of injection)). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her right leg starting with knee and passed through the ankle), PAIN IN EXTREMITY (arm pain) and PRODUCT DOSE OMISSION ISSUE (she hasn't received the 2nd shot yet). At the time of the report, RASH ERYTHEMATOUS (arm has a red rash), PAIN IN EXTREMITY (pain in her right leg starting with knee and passed through the ankle), PAIN IN EXTREMITY (arm pain), PRODUCT DOSE OMISSION ISSUE (she hasn't received the 2nd shot yet), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PAIN (whole arm hurt (site of injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: The Significant follow up case was received on 03-MAY-2021. Events were updated.
Sore, red, raised rash 3 inches in circumference appearing 12 hours after injection.  Chills and fever 20 hours after injection., even tough I took 1 Tylenol before injection. I had to take 3 Tylenol and 1 ibuprofen together every 4 hours  and was unable to work the second day.
14OCT97 mom noticed small red spots across child abd @ 7:30 in the evening;15OCT97 small macular spots across child abd & back, about 40 in number;no itching;no fever;went to NP stated was not infectious;17OCT97 rash has faded mom states;
Injection site pain; Headache; general body pain; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2008, the patient received the 1st dose of Shingrix. In November 2018, 1 day after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the patient experienced injection site pain. In November 2018, the outcome of the headache and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 62 or 63 years. In mid-November 2018, the patient received Shingrix on left arm. 24 hours after receiving Shingrix, the patient experienced headache and general body aches which lasted for 1 week. The patient also experienced sore arm where injection was administered for about 3 to 4 days. The reporter did think the effects were related to product and was prepared based on product information (PI) safety information. The reporter did not consent to follow up.
been suffering for 6 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and had been suffering for 6 weeks now. The GlaxoSmithKline said it would have been much worse without a vaccine. The patient couldn't even imagine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Onset: Quick onset with progressive pain and muscle weakness throughout hip, buttocks, left   lateral Femur and anterior thigh and lateral knee. Within 4 hours extreme nerve pain and throughout all regions- unable to walk, sit or stand or move leg. NO previous strain, or trauma to back or legs. Pain 10/10. Treatment: 2 days after onset. Fascial Distortion Method received. FLEXERIL prescribed. Initial relief for 4 hours only. Pain and immobility returned. 10/10. Treatment 4 days after onset: Stretching and pelvic re-alignment with Prednisone prescribed 10mgx10 days. 2 1/2 week duration of symptoms. Physical therapy initiated 10/31/18.
Supraclavicular lymphadenopathy  - moderate swelling, redness and tenderness above L clavicle, first noticed 48 hrs after vaccine. Also mild axillary tenderness on L side.  No symptoms on R side, and no elevated temp.  (Vaccine was in L arm)   Also felt mild malaise and fatigue the previous day, 10/7, relieved with sleep. Took one Aleve tablet the evening of 10/8 for discomfort over L clavicle, with relief.  Swelling gradually diminished over the next 2 days.  Today 10/11 there is only slight swelling and mild tenderness there. Still have had no elevated temp.
01Mar96 pt recv 1 dose vax. 03Feb98 pt devel 15 varicella-like lesions. 3 other pts reported w/adverse exp following vax w/varicella virus vax. (WAES98020281,98021662,98021663).
It started with tingling in feet and then went to my hands. Later, then twisting in my toes, then moved back to legs and arm. I also felt it in my mouth. A week went by; I then went to the ER. They did blood work, which was normal.  The offered to lumbar pincher to check for Guillain-Barre, but I decided not to do it because the symptoms did not fix.  They discharged me. I see a neurologist, she diagnosed me with small fiber polymer. So, the next week I had an EMG done which came back normal. She said it will go away in three to four months. But it is still there all day, every day. I feel like a small pain in my abdominal. I been having slurred speech as well.
Next day post vax, the pt was crying and in crib with whole body shaking. Pt felt very warm and was given Motrin. Parents took her to ER and she was dx with fever and chills post vaccination.
A husband reported that his wife received vax on 11/19/99. Two days post vax, she developed nodules in her fatty tissue over her entire body. A biopsy of the nodules reportedly revealed that they were benign. Follow-up information received from the physician provided that the biopsy revealed T-cell lymphoma. The physician does not feel that the lymphoma was caused or aggravated by the vax administration. He stated that 'it was just a coincidence' and 'not at all related' to the vax. Additional info received on follow-up from the physician on 04/08/2002 indicated thatt he pt partially recovered. She was treated for T-cell lymphoma and that the number of nodules was decreased from 20 to 2. The pt did not have follow-up with the physician since 05/19/2000.
arm sore  hard to move it ....chills. muscle pain, headache,fatigue..
sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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.
After the first shot it changed the cycle of my menstrual cycle. Upon thst change I had major cramping and heavier than normal flow. After each vaccine it changed my cycle dates and the cramping and flow stayed heavy which wasn't the case many years dating back to initially having my cycle. I had a nodule on my thyroid that doctors began watching in 2020 which progressively grew in size each year in ultrasound which progresses to multifocal papillary carcinoma and hasimotos disease since having each vaccine. A few months after receiving the 3rd vaccine I developed major edema in my left leg . That I never had prior. I went to multiple vascular doctors and a cardiologist . Tested for multiple conditions and even had procedures. All conditions I never had prior to April 27, 2021
pt recvd vax in 1990 & pt exp an unspecified react or infection; No further details were provided;
the left eye stopped seeing; cancer of the 4th stage appeared; severe pains in the muscles, in the bones began; severe pains in the muscles, in the bones began; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 1, single (Lot number: FH8020) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Breast cancer 2 stage" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BREAST CANCER STAGE IV (medically significant, life threatening) with onset 10Sep2021, outcome "not recovered", described as "cancer of the 4th stage appeared"; MYALGIA (life threatening), BONE PAIN (life threatening) all with onset 10Sep2021, outcome "not recovered" and all described as "severe pains in the muscles, in the bones began"; BLINDNESS UNILATERAL (medically significant, life threatening) with onset 10Sep2021, outcome "not recovered", described as "the left eye stopped seeing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2021) Negative, notes: Covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of blindness unilateral, breast cancer stage iv, myalgia, bone pain.  Additional information: If other vaccine in four weeks: No. Other medications in two weeks.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.