chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnose with a granuloma annular; "Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"; Swollen on my foot/ "on the top of my foot, don't know how deep it goes"; "I have had an issue with a gross rash in my foot and leg"; "Much pain"; "Mainly I was in bed"; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (Diagnose with a granuloma annular), PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed"). On an unknown date, the patient experienced GRANULOMA ANNULARE (Diagnose with a granuloma annular), PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes") and RASH ("I have had an issue with a gross rash in my foot and leg"). At the time of the report, GRANULOMA ANNULARE (Diagnose with a granuloma annular) and RASH ("I have had an issue with a gross rash in my foot and leg") had not resolved and PAIN IN EXTREMITY ("Pain and swollen on my foot"/ Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PERIPHERAL SWELLING (Swollen on my foot/ "on the top of my foot, don't know how deep it goes"), PAIN ("Much pain") and BEDRIDDEN ("Mainly I was in bed") outcome was unknown.            Concomitant medication included unspecified Thyroid medication. Treatment medications included unspecified 2 different ointment creams.  Doctor gave her 2 different ointment creams but, it has not help yet and granuloma takes it time and maybe don't even go away   This case was linked to MOD-2021-370406 (Patient Link).
On 2/7/22, Patient woke up with severe chest pain and pain radiating down his left arm to his face and back.  The pain was described as "the worst pain ever" and felt like "crushing and burning pain".  Once at the hospital, he was taken to the cardiac catherization lab where a small blood clot was lodged in his LAD.  The clot was removed and patient remained in the hospital until his troponin level normalized.  He is now taking life-long medications--blood thinner and beta-blocker as a result.  His heart sustained tissue (ischemic) damage as a result of the MI.  At the time of the MI, patient had no medical conditions and was not taking any prescribed or over the counter medications.
Moderna COVID?19 Vaccine EUA Woke up during the night with 103 fever. From then until around 7 my entire body would spasm like i was stretching then relax.  I got up about 3:30 and my joints felt as though they were liquid.  I began taking tylenol at 7 which eased the spasming and fever. I had the headache all the next day in the back of my head and into my neck.
I developed thoracic neuritis.  I have intercostal pain and thoracic back pain. The back pain started with COVID in Dec 2020.  The intercostal pain started the first of March 2021. By April 16, 3021, I?m in debilitating pain. I?ve had MRI, CT scan, MRI with contrast, lab work. Etc.  I?ve seen Medical Dr, Spine Orthopedist, Neurologist, Cardiothoracic surgeon, and Rheumatologist. All agree that  vaccine added insult to my body after having COVID and I?m having an inflammatory response.
ascending weakness, areflexia, lack of sensation, progression to quadriplegia; GBS syndrome
Patient is pregnant and recieved the flu mist for H1N1.  Told by local health department that a VAERS should be completed .11/18/2009 OB-GYN records , patient pregnant, received H1N1 vaccine, no adverse reactions reported.
Information has been received from a health professional concerning a 45 month old female patient with a history of premature twin birth who on 01-SEP-2004 was vaccinated with a dose of VARIVAX (Oka/Merck). Concomitant therapy included DTAP-IPV. The health professional reported that the patient experienced zoster on left arm and wrist, which was treated with BENADRYL. On 01-OCT-2007 the patient was vaccinated with PROQUAD. No further information is available.
Initial soreness in injection, persisted for over two months, currently participating in physical therapy for muscle injury.
disruption in my monthly cycle with moderate complications; clotting; migraines; insomnia; tinnitus; fatigue; Irregular Menstration; had a very sore arm; Arm was stiff; Moderna Knot which was large; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting) and MIGRAINE (migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (latex powder). Concomitant products included MYDAYIS from 02-Mar-2020 to an unknown date for ADD and Obsessive-compulsive disorder.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large) and HEADACHE (Headache). On 09-Mar-2021 at 11:30 AM, the patient experienced MYALGIA (had a very sore arm). On 11-Mar-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular Menstration). On an unknown date, the patient experienced MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus) and FATIGUE (fatigue). On 06-Mar-2021, MUSCULOSKELETAL STIFFNESS (Arm was stiff) had resolved. At the time of the report, VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus), HEADACHE (Headache), MYALGIA (had a very sore arm) and FATIGUE (fatigue) outcome was unknown and MENSTRUATION IRREGULAR (Irregular Menstration) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-095551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information form received on 01-JUN-2021. Updated initials, race, ethnicity, height, weight. Added vaccination time, concomitant medication. Added event myalgia, menstrual disorder, coagulopathy, migraine, fatigue, insomnia, tinnitus, Irregular Menstruation.
1 week after vaccination (11/13/2021), injection site became pruritic, painful, hot, swollen, and erythematous. Pruritus improved after taking 25mg diphenhydramine PO and applying topical triamcinolone cream. Reminder of signs persist on 11/14/2021.
PT BECAME UNRESPONSIVE, CLAMMY, COOL  W/ UNSTABLE VS.   NONREBREATHER @15L, STERNAL RUB CONT TIL EMS ARRIVED.  PLACED ON MONITOR IRREGULAR JUCTIONAL RHYTHM NOTED, TRANSFERED TO NEIGHBORING HOSPITAL,  AWAITNIG TEST RESULTS.  PENDING ADMIT
This spontaneous report was received from a pharmacist refers to a patient of 2 month old and on unknown gender. Medical history was not reported. On an unknown date the patient was vaccinated with PEDVAXHIB injection, lot # J015437, expiration date 09-OCT-2016, route, dosage and frequency were not reported. Concomitant therapy included multiple vaccines unspecified. The reporter informed that on an unknown date the child experienced inconsolable crying and seizures with the lot # J015437. The physician has requested a lot check for this number. The patient sought medical attention by an office visit. Upon internal review the seizures was determined to be medically significant. The patient's outcome with the events was recovering. This is one of several reports received from the same source. Additional information has been requested.
Per patient's daughter: around 1 pm patient started acting confused. At one point, patient thought it was Valentine's Day. Daughter also stated that patient ate a Kleenex.   Patient was treated with 2 L of fluids and cardiac monitoring. Patient's AMS resolved by next morning. Patient returned to baseline and was discharged after 36 hours of observation.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose and route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the highest recorded temperature of 48 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Thirteen days after vaccination, an  itchy rash developed at the injection site causing swelling, redness and welts. Today is the fourth day and it still persists.
Information regarding PREVNAR was received from a company representative regarding a caller who had an unspecified concern regarding PREVNAR13. The patient received a dose on an unspecified date.  Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced unspecified concern regarding PREVNAR13 (non specified reaction). The outcome is unknown. No additional information was available at the time of this report.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown if patient was diagnosed with COVID-19 test positive. It was unknown if patient was having acute illness at the time of vaccination and chronic illness.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 48 years 3 months. No concomitant drug reported. It was reported vaccine administrated beyond use date after the thaw process. There was no patient who had any adverse reactions and no reports of any reactions after the administration of the vaccines. No treatment information was provided by the reporter.
2nd dose pfrizer on 1/29/21, positive pregnancy test on 2/7/21, also 2 positive blood HCG levels.  Good 6 week Ultrasound 3/11/21  8 week ultrasound diagnosed with missed miscarriage Natural Miscarriage on 3/24/21
Nurse administering vaccine inadvertently gave 1ml dose to patient instead of 0.5ml dose
At the time of first vaccination shot, I experienced an anaphylaxis reaction including constriction of throat, difficulty swallowing, inside of cheeks swelling, lips numb and inability to take a deep breath.  I waited at the vaccination site for 30 minutes.  No treatment was requested since I began to feel a little bit better after 30 minutes.  It took approximately 4-1/2 hours to 5 hours to completely be able to swallow without difficulty and feel that I could actually take a deep breath.  I contacted my Primary Care Physician and she advised that she is "not comfortable with my receiving the second shot" and told me to cancel my second shot.
Pt received MMRII vaccine on 3/12/01. Was being treated for otitis media with Augmentin. On day 8, (3/20/01) pt developed fever of 102F and erythema multiforme with rash and swollen hands and feet. Required treatment with prednisone and antihistamine. Condition resolved in 5 days.
After HPV sig vasovagal reaction with dizzy, pale BP 88/58 while sitting shaking; lied down resolved w/in 5-10 min BP 115/78.
fever up to 103.7 started about 22hr p/vax w/swelling around lt deltoid area;fever controlled w/APAP;16OCT96 unable to sleep, pain & fever;17OCT96 erythema, induration, swelling lt deltoid area;unable to lift arm;
This spontaneous report as received form a pharmacist and registered nurse refers to two patients of unknown age (gender not reported). On 28-MAY-2014 the patients were inadvertently vaccinated with a dose of expired ZOSTAVAX (lot # J000429, exp. date 10-APR-2014) subcutaneously (dose and lot# not reported). No adverse effect reported. Additional information has been requested.
I have a rash covering many parts of my body that itch  constantly. I don't know if this rash is a side effect or not of the vaccine. I will not file false information.
Soreness and swelling in right arm on 9/6/12, redness, swelling, sore, itchy and warm to touch on 9/7/12. Advised by nurse to take Advil and Benadryl for itching and pain. If still red, see PCP.
Pt vax w/ hepta B; exp severe urticaria.  Tx w/ benadryl.  Consulted allergist.
This subject is a one and half year old female who was admitted to the hospital due to complications from congenital anomalies she has had since birth; AV canal with severe coarctation, severe clotting disorder probable factor 13 mutation. She was enrolled P3T08, a Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the standard of care. The subject received three doses of Infanrix for primary series and last dose of DTaP on 6/26/03. Also given on same date was IPV, HboC, hep B and Prevnar. Per the pt's medical doctor, the subject had severe congenital anomalies since birth. The pt was born with AV canal with severe coarctation which was repaired in the first week of life. Volvulus was repaired in May 2002. Subject had Glenn operation in January 2003 which failed and was hospitalized in the pediatric ICU from January 2003 until expiration. The subject likely had a factor 13 mutation/ severe clotting disorder. During hospitalization the subject had repeated elevated white counts probably secondary to sepsis. The pt expired due to congestive heart failure. Autopsy was done and the records have been requested. These events were reported by the investigator as unrelated to the study vaccine. A 15-day follow up report was received 12/29/2003 and adds no new info except for the 4th vaccine reported to be Prevnar. Follow-up information 14 April 2004: After a medical reveiw of the case, a new version of the report has been generated to add the adverse event "condition aggravated" including lymphedema, since due to her progressively worsening status and her potential long-term outcome, the decision was made by the family to move the patient to the care suite and to withdraw the support from the patient. Also, the date of onset for Factor X111 disorder was corrected from 6 April 2003 to 6 APril 2002.
Friday (10/7) after the vaccination, patient experienced fever and chills 5 hours following immunization. However Saturday (10/8), patient experienced a yellow film on the tongue, swelling of the tongue and fever blisters on the lower lip.  Sunday (10/9) she also experienced swelling of the lips and drooping of the lips downwards.
I woke up with a huge knot where the shot was given. Painful,, red,, hard,, swollen. General malaise was first, started around 10:30am. Progressively got worse as the day went on. At around 1:00pm started to have chills and felt feverish. Checked temperature at 2:00pm, 100.4. These symptoms continued until 10:00pm. Chills, general malaise, fever, body aches. On 3/10 all symptoms were gone. I did take Tylenol throughout the 2 days this was happening.
Headache, chest pain = tightness, facial swelling. Hives (head and knees only).
10x10 cm area erythema & edema at site of injection x 3 days, R deltoid.
Patient received vaccine and moved to observation chair. Within about 5 minutes, patient proceded to experience a syncope episode. Total episode lasted about 30 seconds, and patient spontaneously awoke. Upon awakening, patient requested water, and we also offered crackers and he accepted both. Patient waited in observatory for a total of 30 minutes. At time of departure, skin color was normal and patient was not experiencing weakness or confusion.
Hot to the touch; Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.; just a little ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PAIN (just a little ache) and VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A-2A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur on 11-Jan-1993, Endometriosis on 10-Jan-2004 and Hypothyroidism on 05-Jan-2012. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ETHINYLESTRADIOL, LEVONORGESTREL (AVIANE) and LYSINE (L LYSINE [LYSINE]) for an unknown indication.  On 14-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (just a little ache).   On 23-Jan-2021 at 5:00 AM, the patient experienced VACCINATION SITE WARMTH (Hot to the touch).   On 23-Jan-2021 at 5:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.).   On 31-Jan-2021, VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.) had resolved. At the time of the report, VACCINATION SITE PAIN (just a little ache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-020492 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included reporter's contact information. On 19-Apr-2021: Additional information received included: Patient initials and demographic details, Other relevant history, concomitant medications. Additional event and details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020492:Same reporter/ Different patient (Neighbor case)
This spontaneous report as received from a nurse refers to a 7 month old patient of unknown gender. On 26-SEP-2014 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Redness, pain, swelling, bruise at injection site. Left arm, sub Q.
85 year old vaccinated male was admitted after he fell at the facility and tested (+) for Covid-19 infection. He suffered from nasal bine fracture due to the fall. He remains unresponsive since admission. He has advanced dementia as base line. His overall condition did not improve. He was made DNR. Wife requested hospice involvement today. He will be transferred back to the facility under hospice services in comfort measures.
pt devel nasal congestion & discharge 2DEC92 & on 4DEC92 mom noticed bilateral preauricle swelling-mild irritability;
Redness around injection site. Patient states itchiness on other upper arm that evening and resolved without treatment. 2 days following the vaccine she noted pain in her elbow. Initially thought it was from overuse but now feels it is from the administration of the vaccine in that arm. MD today stated he thought it was 'serum sickness'.
Eye redness and bloodshot eyes after 1st dose that never cleared up. After 2nd dose redness, bloodshot eyes worse as well as feel pressure around the eyeball.
pt ran a temp of 99.1 x 2 days p/vax; 4 days p/vax fine raised rash appeared on lt thigh around inj site only; rash lasted 3 days;
Per phone call from the child's mother, the child had noticed red bumps on her chest today. The child's mother stated that the red bumps were not there yesterday. The child's mother denied that the child had any trouble breathing or fever and also denied any itching with these red bumps.  She also denied any other adverse symptoms. The child's mother was advised to continue to monitor the child for any further reactions and phone the child's physician as well.
stomach upset; lightheadedness.; sore arm; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset), DIZZINESS (lightheadedness.) and PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A210) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Depression.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (lightheadedness.) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset), DIZZINESS (lightheadedness.) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Allergy medicine and medication for depression. Treatment information was not reported.
Pt recv vax on 3/25/99; immediately post vax pt exp weak feeling, headache, nausea, sleepiness, chills, fever (99.5)
after 2nd vax, severe fatigue 2 days, then  on fourth evening developed sudden tachycardia over 200bpm, chest pain, hypertension breaking through meds, malaise. Went outside to cold weather to the face/ice, bpm decreased slightly to 150s by arrival atER. EKG:sinus tachycarfia. Given labetol, amiodorone. Heart monitor after HR decreased showed some episodes of NSVT. Held overnight for observation
Swelling, sore on skin, muscle pain, red about 4" diameter, itching