chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wrist pain; Top of her hand,Shooting pain up to her fingers; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-017744), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Top of her hand,Shooting pain up to her fingers) and ARTHRALGIA (wrist pain) in female patient of an unknown age who received apixaban (Eliquis) (batch no. 1790399) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation. On an unknown date, the patient started Eliquis (batch no. 1790399) (unknown route). On 21-Jan-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced PAIN IN EXTREMITY (Top of her hand,Shooting pain up to her fingers) and ARTHRALGIA (wrist pain). The patient was treated with paracetamol (Tylenol Arthritis) for Pain in extremity and Wrist pain,. The action taken with Eliquis(Unknown) was unknown. At the time of the report, PAIN IN EXTREMITY and ARTHRALGIA was resolving. For Eliquis(Unknown), the reporter did not provide any causality assessments. It was reported The first one she received on 21 Jan 2021, and approximately 10 days after that, she started having wrist pain. From there, it went down to the top part of her hand and she experienced shooting pain up to her fingers. all of this is occurred in her left arm only. it did improve some because not much of the pain is in her elbow anymore, just a little bit, but the pain is still there when it hits. She does take a couple of Tylenol Arthritis. It gets very painful if she doesn't take something.
Swelling sl area, erythema approx 2.5 in in diameter;@ inject site small pinpoint white area, noticed p/day 3 & area became enlarged further; Day 5 went & saw MD told was allergic rxn; TO never get DTP again;
Sudden sensorineural hearing loss (SSHL), commonly known as sudden deafness; Right ear had a sudden build up of fluid behind my ear drum; Nerve damage; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female non pregnant patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FP7533) via an unspecified route of administration and administered in right arm on 04Apr2021 15:00 (at age of 51-years) as single dose and dose 2 via an unspecified route of administration and administered in right arm on 04Apr2021 (Batch/Lot Number: ER8736) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received drugs within in 2 weeks prior to the COVID 19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient not tested for COVID-19. The patient medical history was not reported. The patient previously took sulfa [sulfadiazine] and experienced drug hypersensitivity. On 10Jun2021, my right ear had a sudden build up of fluid behind my ear drum. By the time I saw the referral ENT doctor, on 09Jun2021 it was determined that the fluid had drained away but nerve damage was suspected. Sudden sensorineural hearing loss (SSHL), commonly known as sudden deafness. On 16Jul2021 I will be having a MRI performed to rule out Acoustic Neuroma. Then hopefully I can start with direct intratympanic injection of steroids into the middle ear. However, the doctors felt that it might be too late to regain full hearing back into that ear. That the nerve damage is permanent. the adverse event result in disability and Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Prednisone. The outcome of events was not recovered.
12 hours after 2nd dose severe shaking and chills along with vomiting and diarrhea for about 3 hours.   The following day chills continued and the level of fatigue was debilitating.  The severe symptoms ended after about 24 hours.  The injection site is still swollen, red and sore.
Pt was given 2nd dose of MODERNA vaccine after receiving Pfizer for 1st dose 1 month prior.
Odd feeling, while attending an event in downtown -- throat tightening at first. As the evening progressed, it felt as if I were having a flu onset. After a brief dinner with friends, I went to bed & kept waking up with a VERY sore torso, ongoing tighness of throat/coughing. It took me awhile to finally take out the "possible side effects" brochure and know that it might be the flu shot. As the day wore on, I also had diarrhea, and when I reached home (a 3-hour drive) I slept for an hour and then felt much better. As the 24 hours progressed, I felt better every hour. I only got the shot because my husband had gotten the flu the previous year, and we travel in the state alot, and his physician recommended it for both of us. I had some time in the afternooon, but was attending a business function that evening. If I had known what type of reaction I would experience, I would not have gotten the shot. The warnings were written, but not clearly expressed, in my opinion.
hives; Initial information was received on 22-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-professional.  This case involves female patient (age unknown) who experienced hives (urticaria), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for unknown indication.  On an unknown date, the patient developed non-serious hives (urticaria) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported that, the patient is on a time limit, and need information before she gets her 3 shot of IMOVAX.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for urticaria.
Second dose on  11/9/21- tremors after two weeks in right hand getting greater than tremors from first one, extra lethargic, swelling on left ankle, constant headache (waking up and going to sleep with one), fevers up to 104, high BP 210/140, woke up 12/5/21 with left side tingling, then facial paralysis, the. Entire left side of body paralysis, later that week, developed stutter/slurring of speech, Parkinsonism, diagnosed with central sensitization syndrome, PNES, FND - never exhibited any of the se symptoms before shot
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 25-OCT-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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.
Developed fever on 8/27 21.  No fever on 8/28/21 bur complained fo fever on 8/29/21 untol 9/2/21 as well as body aches.  Had 2 negative tests for COVID-19 during this time.
Patient called and stated that he had severe flu like symptoms. Chills, fever, and vomiting. Enough symptoms that his wife was going to take him to the Emergency Room. Patient waited it out and symptoms subsided after a couple days.
Tinnitus in left ear (I have 24/7 tinnitus in right ear so I could only tell it was in the left ear). Started about 8 hours after dose.  Lasted Less than 10 seconds each time. Happened about 6-7 times over the next 36 hours  Headache after first dose. Acetaminophen did not relieve it. Started about 4 hours after dose. Lasted about 48 hours.    Muscle ache in neck on opposite side of injection. Lasted about 24 hours.   Muscle pain in injection arm. Lasted about 48 hours.   Fatigue lasted about 48 hours.
heart issue; brain fogginess; couldn't remember were she is; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart issue), FEELING ABNORMAL (brain fogginess), MEMORY IMPAIRMENT (couldn't remember were she is) and HEART RATE INCREASED (fast heart beat) 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.    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 CARDIAC DISORDER (heart issue), FEELING ABNORMAL (brain fogginess), MEMORY IMPAIRMENT (couldn't remember were she is) and HEART RATE INCREASED (fast heart beat). At the time of the report, CARDIAC DISORDER (heart issue), FEELING ABNORMAL (brain fogginess), MEMORY IMPAIRMENT (couldn't remember were she is) and HEART RATE INCREASED (fast heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) fast heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported  Patient got the first dose of the Moderna covid19 vaccine 6 weeks ago.   Reporter did not allow further contact
Metalic taste in the mouth, numbness of the mouth and throat, pain in throat and chest, lightheaded, feeling of high pressure in the head, high blood pressure, nausea, body weakness, pallor. Treatment: taken to ER, given IV medication and IV fluids Outcome: Discharged home after 4 to 5 hours after reaction
Suspected vaccination failure; Shingles; covid; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles for years).   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and coronavirus infection. On an unknown date, the outcome of the vaccination failure, shingles and coronavirus infection were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and coronavirus infection to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case was reported by patient via  interactive digital media and described the occurrence of suspected vaccination failure. In 2019, the patient received shots of Shingles vaccine. After receiving Shingles vaccine, the patient had Covid in 2020 and  then shingles came back. The patient asked if she could take a shot again. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of primary immunization and laboratory confirmation of shingles were unknown. Follow up would not be possible as contact details were not available. The age of patient was reported as 65 year's however it was age at time of reporting not event onset, hence no age was captured in field.
The patient received her vaccine on 10/27/2017. She called our corporate headquarters on 11/19/2017 stating her arm has been sore for 3 weeks following vaccination. Our pharmacy supervisor is going to follow up with her and recommend she sees her family physician to evaluate the pain.
I had blacked out or passed out while driving; Shortly afterwards while driving I suddenly started to not feel well.; Horrible dry, metallic taste in my mouth; Horrible dry, metallic taste in my mouth; VERY dizzy; My whole body started to tingle and I knew I needed to pull over as fast as possible; I feel very "off/extremely upset; This is a spontaneous report from a contactable consumer. This 35-year-old male consumer (patient) reported for himself.  A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 11:00 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergy to medications, food or other product. The patient receives other medication in two weeks include probiotics. After patient received first dose and waited 15 minutes as directed before leaving.  He felt fine at this point. Shortly afterwards while driving I suddenly started to not feel well. Horrible dry, metallic taste in my mouth and started getting VERY dizzy. My whole body started to tingle and I knew I needed to pull over as fast as possible. I turned my signal on to turn right onto a side road and the next thing I know, I woke up in the woods. I had blacked out or passed out while driving and trying to pull off to safety. I was blacked out for at least 15 minutes. Now I feel very "off" and not myself. My car is damaged, and I don't have the means to get it fixed. I'm extremely upset. Adverse events start time: 01:30 AM. Patient didn't received treatment for the events. The clinical outcome is not recovering.
Pt experienced swelling of hands and feet with itching. Pt was treated with antihistamines and symptoms were gone within two hours.
Noted pain in left arm when putting coat on at 4:30 pm. to go home from work. Unable to use arm to drive. Medicated with Tylenol with no relief. Reported symptoms 10/16/07. Left arm tender to touch, swollen at site, warm and raised. Advised to medicate with antiinflammatory and ice.
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS WAITING IN THE OBSERVATION AREA WHERE HE FELL DOWN AND LOST CONSCIOUS FOR FEW SECONDS.911 WAS CALLED. HE WAS COHERENT, NO OTHER SYMPTOMS, VITALS WERE FINE, HE WAS NOT HOSPITALIZED. HE GOT A SCRATCH ON HIS LEFT EAR.
Sore arm at site of injection initially, but later whole body became sore. Developed a headache, and had the chills. Had a bit of a stomach ache, but I don't know if it was caused by the vaccine or not. This all lasted from late afternoon/early evening on the day of injection until the next morning (late morning). I didn't have the chills the whole time, but the achiness and headache persisted for that long.
The patient developed a high fever, body aches, and inconsolable crying the next day after vaccination. A few days later the patient developed constipation. All symptoms ended in approximately 1 week except for the constipation, which continues.
By 2nd day and for one week, had an extreme headache (unlike any migraine). Extreme flu like symptoms for 1 week after vaccination. Reports severe bruising on left arm from collar bone to elbow. "It was black".
Hot at injection site; 2.5 inches in diameter of redness in injection site; Soreness at injection site; Swelling at injection site/injection site raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE SWELLING (Swelling at injection site/injection site raised) and VACCINATION SITE ERYTHEMA (2.5 inches in diameter of redness in injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site/injection site raised). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site) and VACCINATION SITE ERYTHEMA (2.5 inches in diameter of redness in injection site). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE SWELLING (Swelling at injection site/injection site raised) and VACCINATION SITE ERYTHEMA (2.5 inches in diameter of redness in injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Pt seen in my office yesterday for SOB. Pt had breakthrough COVID infection dx with in home test 2 weeks ago. Since then pt having worsening SOB. Found to be hypoxic and wheezing in office yesterday and sent to ER. Yesterday, pt was alert and coherent and even drove to office.   Today, pt is markedly confused.
vomiting (30 mins only about 11 hrs after injection). Chills fever dizzy headache body aches and can't sleep (still happening 35 hrs after symptoms started - 45 hrs after injection)
No adverse event; One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (One of the facilities administered 0.25mL from the red cap Moderna Covid-19 Vaccine (monovalent) formula as a booster dose, instead of the Moderna Covid-19 Vaccine, Bivalent.).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Patient developed headache and lightheadedness about 30 minutes following injection. Vitals were normal. She was provided with food/drink and observed for 30 minutes with improvement.
Patient was exhibiting signs of seizure activity, guardian states patient has history of seizures, mostly grand mal bus some mild.  Patient unresponsive with mild tremors in hands and feet.  Respirations were nonlabored, BP 140/82.  EMS called and was transported to ED.
No adverse event; they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 16-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2023, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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.   No treatment medications were reported No concomitant medications were reported  Caller stated that they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose. They were told that they need to redo the 1st dose. They want to know if this is true. Agent asked if caller is able to provide their contact details 1st before proceeding to assist them but call got disconnected. Callback cannot be made as phone number had not been obtained. Submitting AE with limited information. Country chosen as the default country of occurrence as agent did not have ample time to confirm this.
immunization given, waited 10 min. left clinic,then fainted in car, was stiff and shaky. ambulance was called, transported to er via ambulance.  was diagnosed with low blood pressure, had ct scan done at er
body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headaches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070h21a, 026c21a and 007c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced MYALGIA (body aches). 23-Dec-2021, the patient experienced HEADACHE (headaches). At the time of the report, MYALGIA (body aches) and HEADACHE (headaches) had not resolved.            Treatment details include- Pain killers on 23th December. No concomitant drug details were reported.   This case was linked to MOD-2021-426933 (Patient Link).