chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm where i got the shot is warm; Baseball size knot on my arm; Aarm where i got the shot is very red; Arm where i got the shot is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm where i got the shot is warm), VACCINATION SITE MASS (Baseball size knot on my arm), VACCINATION SITE ERYTHEMA (Aarm where i got the shot is very red) and VACCINATION SITE SWELLING (Arm where i got the shot is swollen) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Arm where i got the shot is warm), VACCINATION SITE MASS (Baseball size knot on my arm), VACCINATION SITE ERYTHEMA (Aarm where i got the shot is very red) and VACCINATION SITE SWELLING (Arm where i got the shot is swollen). At the time of the report, VACCINATION SITE WARMTH (Arm where i got the shot is warm), VACCINATION SITE MASS (Baseball size knot on my arm), VACCINATION SITE ERYTHEMA (Aarm where i got the shot is very red) and VACCINATION SITE SWELLING (Arm where i got the shot is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
This spontaneous report as received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot # K026247, exp. 29-JAN-2017) (route and dose unspecified). There was no concomitant medication described. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Profuse sweating 14 minutes after injection, dizziness and nausea. overwhelmed my body and limbs. lasted 35 minutes before I could leave the store to get in my car. felt fatigue for first 1 hours.  Then at 10 hour mark severe fatigue low grade fever 99.1.  At 22 hour mark sever headache, spine ache neck ache, loss of appetite,  heartburn,/GRD, fatigue,muscle fatigue, fever 99.9 controlled with Tylenol brain fog,  Severity of these symptoms still persisting as of 72 hours after injection.
Mouth ulcers; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth ulcers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced MOUTH ULCERATION (Mouth ulcers). At the time of the report, MOUTH ULCERATION (Mouth ulcers) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.
Lightheaded,  hard to swallow, numbness in center of chest, left hand, and all fingers with the middle being the worst, numbness in back of neck.  Warm water on hand helped numbness improve.
Pain in the right injected arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had arm pain in the right injected arm. The reporter did not consent to follow up. This case has been linked with US2020231823 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231823:Same reporter
Red circular area at insertion site. Warmth noted to site. Itching noted at site. Fever. Nurse on the skilled nursing unit advised her to go to the E.D. for evaluation. She was prescribed KEFLEX 500mg 1 capsule every 8hrs for 7 days and Dexamethasone 4mg twice daily for 3days. Diagnosis-Cellulitis.
about a week after first dose I felt lightheaded, dizzy and vertigo type symptoms. My blood pressure has also been low. I feel a sense of weakness and heaviness throught my body at times.
Burnt Tongue syndrome/numbness in roof of mouth, tongue, accompanied with pain in tongue and upper and lower  jaw.  Inflammation in lips, facial numbness, across nose, cheeks, mouth.  Blood pressure rose to a consistent 205/98.  resulted in a Change in blood pressure medication.  Trying different medications to relieve inflammation.
All my joints ache.  I have a headache.  My eyes are bloodshot and I have no appetite.
symptoms started after 15 seconds, felt fingling, after one minute felt heat and pain, started sweating, blood pressure dropped to 81/62 and pulse was up to 78, after 10 minutes sweating stopped and he felt better, blood pressure was up to 112/81 and pulse had dropped
Discomfort in right leg for several weeks.  This eventually resulted in a swollen right calf and an eventual ER visit.  It was determined that I had a DVT in my right leg on 10/24/2021.  I then went to see my PCM and discussed a shortness of breath I'd been having for several weeks.  She sent me for a chest scan where it was revealed that I had several PE's in both lungs.   At that time I was sent to see Dr. and he continues to treat me for blood clots.
unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient had no pertinent medical history, drug reactions or allergies and did not take any concomitant therapy.  On 04-AUG-2020, the patient was intramuscularly vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (dose was not reported, lot # S036495, expiration date 13-SEP-2021), as vaccination. On the same day, few hours after vaccination, the patient experienced unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow at the injection site. The symptoms worsened overnight. On 05-AUG-2020, he had a telecalth visit with the physician and was prescribed acetaminophen (TYLENOL) and diphenhydramine (BENADRYL). The patient did not have any laboratory test performed. The reporter requested a lot check for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S036495 with expiration date of 13-SEP-2021. At the time of the report, the patient had not recovered from the events. The relatedness between the events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Received phone call from patient at 1:30pm today, complaining of discomfort to left arm since 9:00 pm last night. Patient stated, "My left arm was hurting me yesterday evening, and this morning I did not go to school because it was really sore that I could not move it very much." Patient was asked to describe pain and rate on a scale of 0-10, Patient stated "My pain is a feeling of soreness at the injection site and I would say the pain is a 7.2." Advised patient that soreness may occur per Vaccine Information Statements. Patient instructed to take a shower and let warm water flow on his arm and take a pain reliever (TYLENOL or MOTRIN) for the discomfort. Denies any other side effects at this time. Advised if symptoms worsen to go to the nearest Emergency Room for further evaluation and management. Patient verbalized understanding. Patient contacted again at 2:30pm today to follow up on discomfort. Per patient, "I took a shower and did as instructed and my arm feels better now." Reinforced if pain or any other side effects noted or worsens to go to the nearest Emergency Room. Patient verbalized understanding.
Pt recvd vax 1SEP92 pt devel a sz like reaction which was described as falling from a chair w/eyes rolling & jerky movements of hands; was combative, upset & crying; taken to a local emergency room did where did not remember the reaction;
Diplopia; This is a spontaneous report from a Pfizer sponsored program Pfizer RxPathways.   A contactable male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown) dose 1 via an unspecified route and administration, on an unspecified date as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, after the first shot patient developed diplopia. Not saying that the vaccine was the root cause, but some other variables were discarded with the MRI. Patient was wondering if there was any place where they could record these not regular side effects and even follow. For example, he was wondering if others had the same issue and if after sometime was rollback this type of side effects by them. The patient underwent lab tests and procedures which included MRI: Unknown result, some other variables were discarded with the MRI on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Post vax trial pt c/o wt loss, diaphoresis and excessive tiredness. Also, chills, no fevers, nausea, vomting or dysphagia. Diarrhea occurred follwoing initial dose. Abdominal cramping after that.  Hypertens also noted.
Rash & UrticariaPruritus Narrative: Developed diffuse redness and itching about 90 min after 3rd vaccine (booster). She had a similar reaction with her 1st COVID-19 vaccine. Prior to the 2nd vaccine she took Benadryl and did not have any reaction. Seen in the ED and symptoms resolved with Prednisone and Benadryl. She was discharged to home.
Information has been received from a registered pharmacist concerning a 68-year-old male with allergies to levofloxacin (LEVAQUIN) and perhaps ciprofloxacin hydrochloride (CIPRO) who on 12-DEC-2007 was vaccinated intramuscularly (previously reported as subcutaneously) in the left deltoid with a first 0.65 ml dose of ZOSTAVAX (lot# 658838/1412U).  Concomitant medication included lansoprazole (PREVACID), an unspecified thyroid medication, ezetimibe (+) simvastatin (VYTORIN) and ramipril (ALTACE).  There was no illness at the time of vaccination.  A day after receiving the vaccination, on 13-DEC-2007, the patient developed a red rash on her left upper scalp.  This rash occurred from 13-14-DEC-2007.  On 15-16-DEC-2007 he developed hives and shingles lesions on his left forehead, scalp, nose and around his left eye.  On 17-DEC-2007 he was seen by a physician's assistant who diagnosed him with shingles and prescribed valacyclovir hydrochloride (VALTREX), 1 gm; hydroxzine HCL, 25 mg; and hydrocodone/APAP tab 5-500 mg.  The patient was referred to an optomologist for left eye swelling, he found left 5th nerve opthalmic division with ocular involvement and prescribed prednisolone acetate (PRED FORTE) 1% drops and brimonidine tartrate (ALPHAGAN) 0.1% drops.  On 19-DEC-2007, he returned to the opthomologist and found that the eye pressure was 34.  On 20-DEC-2007, his eye pressure dropped to 25.  Some viral lesions and cell involvement in the left eye.  No outcome was reported.  Additional information has been requested.
Significant and incapacitating insomnia leading to ER visit/anxiety/depression/inability to work.  Worsening insomnia noted within one week of 1st injection (8/13/21) but I was still functional and able to work.  started to try OTC meds like benadryl and unisom and melatonin to help with sleep.  After 2nd injection (9/3/21), insomnia significantly worsened and I was then started on different prescription medications to help with sleep.  Lack of sleep was starting to cause anxiety/depression/inability to function to care for self/family/and inability to work.  I was started on SSRI.  These sleep meds did not help and ultimately ended up in the ER (9/27/21) due to severe insomnia causing me to feel psychotic.,  After ER visit, I continued to try different sleep medications until one finally worked for me at 5 wks  (10/30/21).  I continued sleep medication until 9 wks after ER visit (11/23/21) when I was finally able to wean off.  I attend outpatient psychotherapy program for 2 wks (10/29-11/12/21).  Finally able to return back to work at 7 wks after ER visit (11/15/21).  I still continue to struggle with insomnia though it is significantly better.  I continue with low dose SSRI and therapy visits.  I'm back to work at 80% of prior functioning level.
Pt given varicella vaccine 5 days after receiving MMR vaccine on 8/18/21
Patient fainted, difficult to arouse (12 sec) utilized ammonia to arouse. Patient stopped breathing during fainting spell. Patient cold, pale and clammy fingertips blue with c/o tingling in fingertips then legs. Blood pressure 92/58, pulse 60. RR16. 911 called. Patient transported to nearest ER.
Patient called call center on 4/28/21. States she got 1st dose Pfizer vaccine on 4/22/21 at Church. Pt states she got fever, muscle and body aches, headache, fatigue, nausea, abdominal pain and wheezing starting 4/23/21. Pt states fever is gone after 2 days. Pt states she has asthma but have not used inhaler for years and recently used inhaler for her wheezing but only helped for 2-3 hours and the wheezing would come back. Advised pt to go to ED immediately for evaluation and pt states she will have someone to take her.
No adverse event; Vaccine administered to patient after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient after beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient after beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient after beyond use date).    No concomitant medication information was reported.  The vaccine was received at the clinic on 07-Jun-2022.  The vaccine beyond use date was reported as 07-Jul-2022.  No treatment information was provided.
Patient was by mistake administered with Covid- 19 Booster Only Dose (Monovalent) instead of Covid- 19 Updated Booster (Bivalent). Patient was reached a NO report of any side effect or adverse event were made.
Mom states left leg was very swollen from knee to upper thigh. She took him to the extended care on 03/05/04. The doctor stated in his report, "His entire anterior thigh is edematous to the point where it is difficult to make out any antomical markings of his knee". Given Benadryl IM and to continue over the weekend with oral.  Apply ice packs.
Shortness of breathe, anxiety, throat tightening, chest tightening.  Came back to clinic 7/31/07 with these complaints.  Was given prednisone rx for 20mg po bid for 5 days, benadryl 25 mg q4-6h and albuterol
Extreme soreness at injection site, entire arm aches, fingers on that arm swollen, shivering for 13 hours, fever of 101, headache, body aches - especially upper body, nausea, everything got very bright and I thought I was going to pass out but did not. Did not seek any treatment. Started to feel some better by 11:15 a.m. 10-19-18 and can finally use my arm a little bit. Fever is down to 99.6 after 12+ hours of being 101. Was ready to go to the emergency room but then I started to feel a little better. As of right now, I do not think I need to be seen by medical personnel and it seems as if I am recovering.
Pt showed up to the pharmacy three days after receiving immunization with a slightly bruised deltoid, also had edema in lower forearm near the elbow.
Left anterior thigh with red splotchiness surrounding immunization site, slightly warm, no induration. Symptomatic treatment only.
This spontaneous report as received from a nurse via company representative refers to a currently 6 years old male patient (reporter's son). On an unknown dates the patient was vaccinated with two doses (Oka/Merck) VARIVAX; exact dates of each vaccination, anatomical location and dosage were not provided. It was reported that on an unknown date the patient still developed chickenpox even though they received both doses in the series of (Oka/Merck) VARIVAX. The outcome of events was unknown. Relatedness between events and vaccination was not reported. Additional information has been requested.
After leaving office, parents report baby turned blue, when strapped in her car seat lasted few seconds -> pinked up on her own. Brought her right back in.
Mom called at 4:45 PM today. Stated left leg sore-tender day of immunization given. Went to sleep after returned home and did not wake up til 1:00 AM. Took child to ER because could not wake infant. Mom stated ER roused her. Infant went back to sleep at 4:00 AM and did not wake til 12:00 noon. Mom said ER told her infant had an allergic reaction to one of immunizations given 6/11/03; did not say which one.
Developed pain/numbness to injection arm, headache, fever, chills. Then developed chest pains/tightness and shortness of breath. Admitted to hospital on 3/17/2021 in MICU for observation due to tachycardia and SOB.
high pitched scream for several hours rash & fever of 102; pt was drowsy also; reaction started to evening 13MAy93 about 330PM; MD was called on 16MAy93 rash;
Left arm was sore just a little bit; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 15:15 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient took no other medications in two weeks. The patient experienced that left arm was sore just a little bit on 09Jan2021 . No treatment was received for the adverse events. Clinical outcome of the event was unknown.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6205), in right arm, on 20Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 66 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: Amlodipine Besilate, start date: 01Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 antigen test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19 with PAXLOVID.
got mild case of shingles; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date at 60 years of age).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 11 days after receiving Shingrix, the patient experienced shingles. The patient was treated with remdesivir. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient took 1st shot of vaccination in the 2 shot series and got mild case of shingles about 11 days after the 1st shot.  As per physician's advice the patient took the anti viral remdesivir orally for 1 week. The patient asked if she should return for the 2nd shot. The patient's physician and his nurses refused to recommend if the patient should or should not return. The patient commented that the web did not have much data on this particular dilemma and that any advice would be appreciated.