chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on arm; Redness on the arm; Swelling on the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE RASH (Rash on arm), INJECTION SITE ERYTHEMA (Redness on the arm) and INJECTION SITE SWELLING (Swelling on the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE RASH (Rash on arm), INJECTION SITE ERYTHEMA (Redness on the arm) and INJECTION SITE SWELLING (Swelling on the arm). At the time of the report, INJECTION SITE RASH (Rash on arm), INJECTION SITE ERYTHEMA (Redness on the arm) and INJECTION SITE SWELLING (Swelling on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
mom states pt had muscle twitching or spasms @ 630PM;@ about 10:30 began screaming for 10min or so could not be comforted;arms/legs twitching;deep sleep;
Pain and swelling at injection site same day, next day 8/10 headache, fever 102.5, lightheadedness, profound fatigue, nausea, body aches which caused me to miss work
Whole upper arm swelled up and became red from elbow to shoulder - inside and outer arm. At time reporterd-no swelling or redness at all.
Pt received first anthrax vaccine on 10/25/02. Pt did not know she was pregnant at the time of vaccination. Pt had a spontaneous abortion on 11/7/02. Pt had a D&C procedure performed on 11/8/02. Pt was hospitalized for one day on 11/8/02 for D&C procedure.
pt woke up 4 hrs p/vax while held in moms arms stopped breathing then jolted alert (4x) lips became blue;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 09:00 (Lot number: EW0173) at the age of 59 years as dose 3, single for Covid-19 immunisation. Relevant medical history included: "Breast cancer" (ongoing), notes: I'm a breast cancer survivor. My breast cancer is in remission right now; "radiation", start date: May2021, stop date: May2021, notes: I have taken radiation in May of last year. Concomitant medication(s) included: LETROZOLE. Vaccination history included: Bnt162b2 (Dose: 1, LOT: EK9231, Anatomical location of administration: Left arm), administration date: 11Jan2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, LOT: EL3247, Anatomical location of administration: Left arm), administration date: 01Feb2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "not recovered", described as "My arm was little sore"; CHILLS (non-serious) with onset Aug2021, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "low grade fever 100.2"; PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "body aches like crazy"; RHINORRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "runny nose"; HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "not recovered", described as "Numbness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, chills, pyrexia, pain, rhinorrhoea, hypoaesthesia. Additional information- It was reported that patient took Shingles Vaccine prior to the vaccination. Patient reported that Less fever her arm was sore but she didn't think it's swollen, it's just sore but she had fever, runny nose, and body ache. She just wanted to know if is it normal or Is it possible after to have the vaccine to test positive for COVID. No follow-up attempts are possible. No further information is expected.
I had low grade fever; body aches; fatigue for 5 days on first vaccine; Developed sores under my tongue; Chills; Flu; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 51-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW018B) (at the age of 51 years old), dose 1 intramuscular, administered in Arm Right on 17May2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from 2015 and ongoing Other medical history: Multiple Sclerosis, cerebrovascular accident from 2020 to Sep2020, hypertension from 2017 and ongoing, sleep disorder from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing, muscle spasms from an unknown date and unknown if ongoing, tinnitus from an unknown date and unknown if ongoing. Concomitant medication(s) included cyclobenzaprine (CYCLOBENZAPRINE) taken for muscle spasms from 2018 and ongoing; vitamin d3 (VITAMIN D3) taken for multiple sclerosis from 2016 and ongoing; calcium carbonate, lycopodium clavatum, potassium carbonate, quinine sulfate, salicylic acid (TINNITUS RELIEF) taken for tinnitus from 2017 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from 2020 and ongoing; propranolol (PROPRANOLOL) taken for high blood pressure from 2020 and ongoing; melatonin (MELATONIN) taken for sleep disorder from 2014 and ongoing; promethazine (PROMETHAZINE) taken for nausea from 2016 and ongoing; zolpidem (ZOLPIDEM) taken for sleep disorder from 2016 and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for cerebrovascular accident from 2020 and ongoing. On 17May2021 17:00, patient experienced low grade fever, body aches, fatigue for 5 days on first vaccine. She Developed sores under her tongue that have gotten worse over a month. She also started feeling feverish, chills, Body aches. This got worse over 24 hours and lasted five days. Fever was not more than 102. No treatment was received for events. She did not have covid prior to vaccination. She was not tested for covid post vaccination. She did not have known allergies. The patient was visited physician office. Lab data included, low grade fever, Fever was not more than 102 on 17-MAY-2021. The outcome for the event of Developed sores under my tongue was not recovered. The outcome for the event of chills was unknown. The outcome for the events of I had low grade fever, body aches, fatigue for 5 days on first vaccine and flu was recovered on 22May2021.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
some inflammation on neck part skin; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient himself) reported that an 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the caller, called to ask if it was okay for him to take the antibiotics (Cefalexin) prescribed to him by his physician due to some inflammation on neck part skin on an unspecified date in 2021 for 7 days before his second dose schedule on 06Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided weakness; transported to ER. I couldn't lift left leg, 1" off bed and couldn't do the push pull. 1-2 hours symptoms lasted. Everything went back to normal, sent home.  12/30 huge flare up with fibromyalgia; lasted couple days. Flare up occurred the following week.  Getting second shot 1/19/2021
Patient had 2 varicella vaccine injections and was diagnosed with chickenpox on 11-14-08.
This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient   began to have itching on her legs, which spread to the rest of her body as a macular red rash, she received Epi 0.3mg, Prednisolone 45mg po, Benadryl 50mg po, Famotidine 40mg po. Patient was monitored with BP, HR, RR, pulse ox, all normal with increased BP and HR after Epi administered. She was placed supine with legs elevated above the height of the hear.  Pt was anxious so oxygen was administered by nasal cannula at 4 liters per minute.  Within the 15 minutes after meds were given, pt had periorbital edema, a "strange " taste in her mouth as well  pressure in her chest and the rash did not abate but progressed to her face. EMS came and took pt to ED by ambulance.
Hives on chest Rapid heart beat Hands shaking Elevated blood pressure 198/98 All symptoms within 5 minutes of shot Overall shaky feeling the remainder of the day Dull Headache for three days after
Patient described muscle weakness, anxiety, sleeplessness, nausea in AM, headache and appetite loss. Pt was informed that these are possible side effects of the vaccine and when we called to follow up with her 9/24 they had resolved. Patient wanted this reported.
-After the vaccine, the patient experienced magnetic charge underneath where the booster was given and feels it all the way to fingertips and back. -When patient puts magnet where the vaccine was given, he states that the magnet sticks to the site. He feels like he has a "bionic arm" and is concerned with quality control and what he is experiencing. -Feels like as time goes on, it gets worse
Ileus - He was managed with NGT for decompression, IVF and symptom management. He responded well to this management, he began having bowel function, NGT removed, he was started on liquid diet and advanced to regular diet on 1/4. He has tolerated the diet, is having bowel function and now requesting to discharge home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
non-provoked DVT and acute pulmonary embolism on 05/03/2021.  She has no history of such diagnosis and no risk factors otherwise for DVT.
Trigger Thumb; Low fever; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230515000035 (Moderna).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 71 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Feb2021 as dose 1, single (Lot number: 029L20A), on 03Mar2021 as dose 2, single (Lot number: 011A21A) and on 09Nov2021 as dose 3 (booster), single (Lot number: 066F21A) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 23Sep2022 as dose 5 (booster), single (Lot number: AS7140C) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Flu" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (she received her flu shot last year but waited after a few weeks after the bivalent dose.), administration date: 2022, for Flu vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17May2022, outcome "unknown"; TRIGGER FINGER (medically significant), outcome "unknown", described as "Trigger Thumb"; PYREXIA (non-serious), outcome "unknown", described as "Low fever". The event "trigger thumb" required physician office visit. Clinical course: Patient wanted to get her 2nd bivalent Moderna shot but she would also be needing to get a steroid shot for her trigger thumb. She had her trigger thumb 6 weeks ago and she thought this was due to over use and not due to the vaccine. All were Moderna except for the 4th dose. The 1st 3 doses were administered at [Withheld] (drive through event) and the last 2 at the [withheld]. Caller stated that she received her flu shot last year but waited after a few weeks after the bivalent dose. She mentioned that she received the Bivalent dose like a month ago and the only symptom she experienced with this and all the other vaccines was low fever someday after. Patient mentioned that because of her trigger thumb the doctor advised her to wait 2 weeks after the bivalent to get a steroid shot, and she wanted to know if Moderna could confirm if it was  recommended to wait for her steroid shot 2 weeks. The vaccine recipient's Age information was unknown. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
I experienced COVID-19 after my vaccine. I had sore throat, head congestion and little bit of a headache. My symptoms lasted about eight hours. I had taken a COVID-19 test a day prior and it was negative. The next morning, I was not feeling well and I took another test and it was positive. I am not experiencing any symptoms today. I went to urgent care because of my liver condition and my asthma.
Headache,  chills, fever,  irritability,  no appetite,  cough, sneezing,  body aches, immobilized,  heartburn, sore arm, emotional,  unable to care for my children,  nausea,  diarrhea,  vomiting,
6/21 fussy, cranky, clingy, sl. decreased appetite and developed rash on abdomen, neck, legs overall scattered on body incl. hands/feet consistent with MMR Rx as office visit 6/22 for diagnosis.
Symptomatic Positive COVID test after vaccination; Symptomatic Positive COVID test after vaccination; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported for herself.  A patient with unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On an unspecified date, after the vaccination, the patient experienced symptomatic positive COVID test after vaccination with congestion and loss of smell. Event took place after use of product. Lab data include SARS-CoV-2 test which showed positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Patient awoke yesterday morning with her Right wrist unable to be extended. Her wrist was in flexed position and painful to extend. No numbness. Symptoms resolved after 24 hours.
arm has red spots having size of quarter; arm is swollen; painful; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (arm has red spots having size of quarter), PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (painful) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RASH MACULAR (arm has red spots having size of quarter), PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (painful). At the time of the report, RASH MACULAR (arm has red spots having size of quarter), PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Very heavy sweats; Entire body tingling started; Body felt hot all over; Body just felt weird and off; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 13Jan2021 at 18:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. The patient's concomitant medications included ergocalciferol (VITAMIN D) and ethinylestradiol/ norgestimate (ORTHO TRI-CYCLEN). The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 15Jan2021 (day 2; also reported as 08Jan2021), entire body tingling started. On days 3 and 4 (16Jan2021 and 17Jan2021), the patient had very heavy sweats. No fever, just body felt hot all over, and body just felt weird and off in Jan2021. The side effects went away on day 9 (22Jan2021). No treatment was given for the adverse events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on 22Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 1:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 62.63.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10AM, 11AM, 02PM and 03PM, temperature was 32, 32, 32, 35 and 35 respectively, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt recvd TD 22NOV91 on Saturday 23NOV91 pt devel arm soreness chest/back pain (no cough), anorexia, h/a & nausea; chest pain abated but the anorexia, nausea & h/a persisted; pt refused MD for eval/advise;
On 01/08/2021 patient came to facility to report swelling in left arm that started on the 01/06/2021 after the vaccination of Moderna. On 01/07/2021, patient reports severe swelling  and pain in left arm, and not able to lift, move or turn her arm. Patient reports the pain went up to her neck and she is unable to move nor turn her head. Patient reported a fever on 01/07/2021 of 39C and  took 2 pills of 200mg  tylenol on 01/07/2021 at night. The next day on 01/08/2021 she reports feeling a lump on her left neck, and came to the facility to be examined.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 03-FEB-2017, 06-FEB-2017, 07-FEB-2017, 14-FEB-2017, 15-FEB-2017, 16-FEB-2017, 22-FEB-2017, 24-FEB-2017, 06-MAR-2017, 07-MAR-2017, 08-MAR-2017, 13-MAR-2017, 17-MAR-2017, 21-MAR-2017, 23-MAR-2017, 24-MAR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M038224, expiration date 07-SEP-2018 (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced many temperature excursions from -8.1 to -4.9 degrees Celsius for 24 minutes to 1 hour 52 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA011833.
Information has been received from a registered nurse concerning a 19 year old female who on an unspecified date was vaccinated with third dose of GARDASIL (dose, route and lot number not reported). Subsequently the patient fainted and her two front teeth were knocked out. The patent eventually recovered on the same day and was able to "walk out of the office". The patient sought medical attention at the office. Additional information has been requested.