chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received her first dose on 21Jan2021/contracted Covid illness/tested positive for COVID; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided) via an unspecified route of administration, administered in the left arm on 20Jan2021 as a single dose for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. The patient did not receive any other vaccine within 4 weeks and no adverse events following prior vaccinations. The patient stated that she got the COVID vaccine in the middle of Jan (20Jan2021) and later got COVID. She stated a couple days after getting COVID, she got the monoclonal antibody infusion and was told to wait until the first of May to get the vaccine but they did not tell her if she should start over again. She stated that she tested positive on 01Feb2021 and 2 to 3 weeks later, on an unspecified date in Feb2021, she tested negative. She stated that symptoms she had was mainly fatigue and a wet productive cough when she was positive with COVID. She stated that fatigue and wet productive cough started around 01Feb2021 and lasted about 3 weeks so probably ended on 21Feb2021 but she has recovered completely from the symptoms. She received a monoclonal antibody infusion and the medications she tooks were Zpack and Ivermectin. The outcome of the event was recovered on an unspecified date in Feb2021.
Symptoms started this afternoon, fever, chills, face blotchy, also trunk arms and legs. Advised to see MD, blotchy condition cold be hives doctor's office. Did not see doctor: completely over next day.
Sudden and heavy nose bleed, not preceded by nose blowing, injury, sneezing.  No cold symptoms, no headache, no allergy symptoms.  I sat to use the bathroom and blood began flowing out of one nostril.  We applied pressure for thirty minutes.  Visited an urgent care. They went through their nose bleed protocol and bleeding continued despite packing.  From urgent care we visited the emergency room.  The doctor inserted a balloon catheter to stop the bleeding.  After four hours bleeding stopped.  Catheter was removed on 3/29/2021 and at time of writing, no further bleeding.  I have no prior history of nose bleeds.  Doctors did not see anything that may have led to nose bleed occurring.
swollen lymph node in the left arm pit; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 15Jan2021 at a single dose for covid-19 immunisation. Medical history was reported as none. Concomitant medication included desogestrel, ethinylestradiol (KARIVA) in Sep2020 for birth control. There was no history of all previous immunization with the Pfizer vaccine. The patient had no prior vaccination within four weeks. On 17Jan2021, the patient experienced swollen lymph node in the left arm pit which became really noticeable. She reported she feels like she looks deformed due to the swollen lymph node. She had bloodwork drawn about 1.5 weeks ago (Jan2021) but has not received the results from that yet. The event did not require emergency room or physician office visit. The patient was not hospitalized. Outcome of the event was not recovered.
pt had a positive COVID test on 9/10/22; pt had prolonged hospitalization with  reoccurring previous hospitalizations and nursing home stay; 1st hospitalization, pt was sent home with O2; began to have hematuria and urinary retention; pt went back to hospital; dc'd to nursing home; began to have increasing hypoxia and FTT; readmitted to hospital ICU for worsening hypoxic respiratory failure secondary to COVID pneumonia; PEG placed; IV ABX, IV steroids and fluids given; pt continued to deteriorate; DNR/DNI; transitioned to comfort measures; admitted to in patient hospice; pt passed away in the hospital
Pt was taken by Dad after an onset of hives covering his whole body, neck, and face, No breathing difficulties No new exposures, had scrambled eggs at 10am, then motrin after thatPt was given IM Benadryl and Solumedrol, IV fluids and sent home on benadryl elixer and Pediaped.Pt w/ hx of eczema, sees allergis and dermatologist
One week after the injection began to have pain and itching approx. 2 inches below injection site. Following day had a small rash with swelling along the distal portion of the deltoid muscle. 3 days later the swelling and redness had spread to a 4.5" radius, with heat and hardening of the skin resembling cellulitus.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (she was still having issues neck), HEAD DISCOMFORT (she woke up and could not lift her head again), BALANCE DISORDER, SOMNOLENCE, and DECREASED APPETITE (Did not want to eat anything which is unusual for her) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Allergy to chemicals (Dye).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced HEAD DISCOMFORT (she woke up and could not lift her head again), SOMNOLENCE, and DECREASED APPETITE (Did not want to eat anything which is unusual for her). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (she was still having issues neck) and BALANCE DISORDER (she feels unbalance). The patient was treated with PREDNISONE for Muscle relaxation, at a dose of 1 dosage form and DIAZEPAM for Muscle relaxation, at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL DISCOMFORT (she was still having issues neck), HEAD DISCOMFORT (she woke up and could not lift her head again), and BALANCE DISORDER (she feels unbalance) had not resolved and SOMNOLENCE (she slept all day) and DECREASED APPETITE outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information also included Cold compress and Hot compress.  Action taken with respect to mRNA-1273 was not applicable.  Additional information included that the patient was under regular medication as blood thinner, heart medication and other medications.   This case was linked to MOD-2021-092355.
11/03/2009 Mild, had abdominal pains and diarrhea.
Severe headache 36 hours following vaccination. Affected sleep on patient. Extreme soreness in extremity where vaccine was given.
9 patients were vaccinated from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients were vaccinated from an expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients were vaccinated from an expired vial). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (9 patients were vaccinated from an expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The nurse called back saying that she had more information to provide. The vial was actually opened over 48 hours ago.The vial was punctured and left at room temperature on 08Nov2021 at 1:54 PM.Date the vial was initially stored in the refrigerator: 07Nov2021 or 08Nov2021.Total amount of time the vial was exposed to room temperature range: 62 hours.No concomitant medications were reported.No treatment medications were provided.
Within a few hours of getting DTAP & HIB pt started to vomit & have diarrhea, low-grade temp & ataxia.
7 days after vaccine I became fatigued and felt as though I had a low grade fever (did not check). Went to bed and woke up 3 hours later with intense pain at injection site (LUA), swelling and redness.  As a nurse, I have seen similar presentations in patients with compartment syndrome.  Pain was 9/10, swelling was 3x normal size.  PO steroid Rx.  Pain lessened over a few days.  Swelling remained for 10 days.  Even today, 11/30/21, the vaccination site is mildly sensitive to touch
Erythematous rash at injection site persisting >2 weeks - still present at time of reporting
no rxn til 6 days p/vax the pt devel swollen 5x 3.5cm lesion w/red border & tenderness & itches-cellulitis-rx Duricef
hospital  after their first dose of Moderna Covid-19 Vaccine; first Moderna Covid-19 Vaccine around  2 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of HOSPITALISATION (hospital  after their first dose of Moderna Covid-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (hospital  after their first dose of Moderna Covid-19 Vaccine) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (first Moderna Covid-19 Vaccine around  2 months ago). At the time of the report, HOSPITALISATION (hospital  after their first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (first Moderna Covid-19 Vaccine around  2 months ago) outcome was unknown.        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 treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided.  Based on reporter's causality and the available information suggesting  the event hospitalization was related to underlying medical condition, causality assessed as unlikely related to mRNA-1273 vaccine. Causality for Product dose omission issue assessed as not applicable.; Sender's Comments: Based on reporter's causality and the available information suggesting  the event hospitalization was related to underlying medical condition, causality assessed as unlikely related to mRNA-1273 vaccine. Causality for Product dose omission issue assessed as not applicable.
VACCINE WAS REFROZEN; ADMINISTRATION OF FROZEN VACCINE; This spontaneous report received from a health care professional concerned a 46 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Age at time of vaccination 46 years old. No concomitant medications were reported.  On 09-SEP-2021, the patient experienced administration of frozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of frozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, involving the same patient is linked to 20220538693. This case, from the same reporter is linked to 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537341, 20220537683, 20220537688, 20220538146, 20220538210, 20220538238, 20220538292, 20220538316, 20220538347, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538627, 20220538411, 20220538425, 20220538758, 20220538437, 20220538666, 20220540524, 20220540435 and 20220540611.
Severe arm pain radiating down the arm to the hand in the arm in which the injection was given. The pain felt muscular in nature- like muscle spasms and there was some minimal swelling of the upper arm. Very limited range of motion. No fever or redness to the site.
Became lightheaded and dizzy , syncopal.VSS, MD assessed and transported to Clinic for observation
body aches; nausea; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Nephritis and Allergy to antibiotic (IV antibiotic (rash)).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced PAIN (body aches), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN (body aches), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Treatment details included Advil.
Patient went to the ER on 08/4/18 and parent stated that patient developed a temp of 104 the day of her vaccines (08/02/18) and she had pain and redness around the injection site on her right thigh.
Post vaccine pt's arm became pruritic, began to swell, turn red and became tender.
This case was reported by a pharmacist and described the occurrence of injection site soreness in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine for prophylaxis.  On an unspecified date on or after 10/18/05 and on or before 10/28/05 the subject received a dose of Fluarix. The site of injection of the Fluarix was not provided. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, the subject experienced injection site soreness. The injection site soreness resolved on an unspecified date on or before 11/28/05.
Patient reported increased swelling and redness that was spreading on the arm. Went to MD, given antibiotic for cellulitis. Patient also reports having a fever.
Rapid onset, full-body rash starting 3 days after co-administration of COVID mRNA and MMRV vaccines in a healthy 4 year old male Rash is varicelliform, consisting of Indurated, vesicular, erythematous rash Several hundred lesions in total, many closely grouped, becoming confluent and forming hard plaques in several areas, especially the distal extremities Each lesion appears to start as flesh-colored or erythematous papules which grow, becoming indurated and erythematous. These then rapidly form a scab in the center of a an erythematous ring  Lesions of multiple ages found in same areas Does not seem to have an ordered progression from one area to the next, i.e. not centripetal, but rather all seemed to crop up at once in multiple areas, Involves the entire body surface, worst on extremities and throat, and rather mild on trunk and scalp, but spares no surface completely It was extremely pruritic on day 1 but this seems to have abated somewhat by today (day 2) There is no oozing, crusting, bleeding, pus, or other signs of bacterial superinfection Negative Nikolsky sign and there are no areas of skin maceration  Positive for enanthem consisting of petechiae on the soft palate and a few small vesicles on the soft palate and posterior pharynx Patient denies dysphagia  He is otherwise very well. There is no involvement of the eyes or TMs or nasal sinuses and no significant lymphadenopathy.  No fever, normal energy, no cough or rhinorrhea, no abdominal pain, no dysuria The remainder of the ROS and PE are unremarkable.
Fever approximately 12 + hours post vaccination. Alternating Tylenol and Ibuprofen.
Patient was administered the Monovalent dose instead of the Bivalent Dose as a Booster
Drop attack. Fainted without prior physical warning signs. No memory of falling. Woke on ground. Left shin was cut after falling on to dropped food bowl that I had been carrying. I must have dropped bowl, fell onto it and it broke, and that gave me a cut on my shin.
This case was reported by a physician via call center representative and described the occurrence of erythematous rash in a 70-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) and (batch number X3M27, expiry date unknown) for prophylaxis. On 19th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, the dose was an unknown dose. In March 2018, 3 days after receiving SHINGRIX, the patient experienced erythematous rash, raised rash, itchy rash and rash. On an unknown date, the patient experienced conjunctivitis. In April 2018, the outcome of the erythematous rash, raised rash, itchy rash and rash were recovered/resolved. On an unknown date, the outcome of the conjunctivitis was unknown.  The reporter considered the erythematous rash, raised rash, itchy rash and rash to be possibly related to SHINGRIX. It was unknown if the reporter considered the conjunctivitis to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported, that patient experienced red, raised, itchy, stingy rash to his bilateral plank that occurred approximately 3 days after vaccination with SHINGRIX lasting for 3 weeks. Less than a year after receiving vaccination, the patient went to emergency room for conjunctivitis, not for the rash and emergency room did not examine the patient's trunk area for rash during this visit. The health care professional also stated, that patient had a radiological procedure where he got dye. The batch number of the adjuvant was reported as X3M27. The batch number of SHINGRIX 53982 does not exist and was updated to 539A2, as per sales data sheet.
guillain-barre syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023SA053830 (Agency).  A 15-month-old female patient (not pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 20Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 15 months for immunisation; measles vaccine live (MEASLES VACCINE LIVE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; mumps vaccine live (MUMPS VACCINE LIVE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; rubella vaccine live (RUBELLA VACCINE LIVE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine live (oka/merck) (VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL), on 20Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 20Jan2023, outcome "unknown". Clinical course: Initial information received on 14Feb2023 regarding an unsolicited valid serious case received from a non-healthcare professional. This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain bare syndrome after receiving vaccines Pneumococcal Vaccine Conj 7v (CR M 197) (Prevnar, as reported), Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) And Dlphtheria 15/Tetanus/5 Ac Pertussis Vaccine [Daptacel]. On 20Jan2023, the patient received suspects Diphtheria- 15/Tetanus/5 AC Pertussis Vaccine, Prevnar not produced by Sanofi Pasteur and Proquad not produced by Sanofi Pasteur for prophylactic vaccination (Immunisation). On 20Jan2023, the patient developed a serious event of hospitalized and diagnosed with guillain-barre syndrome (guillain-barre syndrome) same day following the administration of Diphtheria- 15/Tetanus/5 AC Pertussis Vaccine, Proquad and Prevnar. This event was assessed as medically significant, and patient was hospitalized due to this event. It was not reported if the patient received a corrective treatment for the event (hospitalized and diagnosed with guillain barre syndrome).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer. A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 at 14:20 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in left arm on 13Mar2021 at 14:20 (Batch/Lot Number: EN6204) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypertension (Verbatim: Blood pressure high; additional information for other Conditions: from years ago) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Patient did not feel a thing and had no side effects to the first dose. The patient experienced tenderness in arm on 11Mar2021, during that evening felt yucky next day (on 13Mar2021), tired wanted to sleep all day, chills for a couple of hours in the afternoon, fever of 99.4 that went up to 100.5, body aches and tired wanted to sleep all day on 14Mar2021. The outcome of the event tenderness was recovering, events feeling abnormal, somnolence and fatigue recovered on 15 Mar2021 and events chills, fever and pain recovered on 14Mar2021.  No follow-up attempts are possible. No further information is expected.
Minutes after administration of vaccination while I was documenting the encounter, I heard yelling in the hallway and someone yelling seizure. I rushed to the scene and was the first on site within five seconds. Patient was conscious  but, I sent my coworker to get the nearest doctor. I layed the patient down to help ensure her safety. Doctor arrived and helped treat patient. It was then determined through the patients mom that she actually passed out and was mistaken in her assumption of a seizure. Vitals were ran by Assistant and was determined by Doctor that it was a vasovagal reaction and syncope. Patient continued lying down for 20 minutes as we monitored her condition before they left.
10 days after vaccine with smallpox, awoke with non painful non pruritic 10 cm red patch with multiple 2-3 mm satellite papules around path extending to elbow. Al;so papules on (B) dorsal wrists. No systemic symptoms.
C/O "itching" & "splotchy" areas all over. Patient took 25 mg BENADRYL ("SOB" at 1230AM & another 25mg at 0230). Came to ED discharged with ATARAX.
RN reporting event after made aware from MA who administered vaccine. NO ADVERSE EVENT OCCURRED. MA gave a higher dose of vaccine than is authorized. Administered was 0.2mL ID, instead of 0.1mL.  Patient waited their 15 min for observation without any complications. RN spoke with provider and reviewed Health Authority standing orders which gave guidance to inform patient for monitor for local and systemic reactions. RN called patient to inform of guidance. Patient will still receive second dose in 4 weeks. No further action necessary.