chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reactive arthritis; Swollen ankles & knees; Patient can limp/cant walk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRITIS REACTIVE (Reactive arthritis) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ARTHRITIS REACTIVE (Reactive arthritis) (seriousness criterion medically significant), JOINT SWELLING (Swollen ankles & knees) and GAIT DISTURBANCE (Patient can limp/cant walk). At the time of the report, ARTHRITIS REACTIVE (Reactive arthritis) and JOINT SWELLING (Swollen ankles & knees) had not resolved and GAIT DISTURBANCE (Patient can limp/cant walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient was totally healthy prior to vaccination.  No treatment information was provided.  Company Comment This spontaneous case concerns a 34-years-old-female patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant event of Arthritis reactive (AESI); the unexpected events of gait disturbance and joint swellling unknown days after 3rd.  dose of  mRNA- 1273 vaccine. The primary schedule was with moderna vaccine in 2021 without exact dates information. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Pulmonary embolus developed 8 days after second injection.  No previous history of vascular events.  No known risk factors.
tongue swelling, slight tightness in throat Narrative: started with tongue swelling and tightness in the throat. No anxiety, SOB,C/p or itching. Color normal.
A mom called with the following report: Her one year old child received the adult version of the Hepatitis B Vaccine. It was dose number 2 of the series. The mother found it on her child's record and notified the office. It is an adult and pediatric office.
Pt. states that after receiving the 2nd dose of Phizer 06/09/2021, started experiencing symptoms 06/11/2021 of soreness continuing throughout the left arm. "Dull" ache and pain continues through the left arm continuously. No noted Primary visit/communications.
Havrix administered instead of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 21-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 10th January 2022, the patient received Havrix. On 10th January 2022, unknown after receiving Havrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's comments: The patient was accidently given Engerix-B instead of Havrix. The reporter consented to follow-up via email. Additional supportive information: The patient was given Engerix-B instead of Havrix which led to wrong vaccine administered. As per the mail confirmation attached the correct suspected product information was Havrix administered instead of Engerix-B.
I had fullness in my ears shortly after the second vaccine that lasted for several months. then as that stopped tinnitus started and is still going on.
patient recieved Moderna covid 19 for very first time. In appoximately 5 minutes later patient passed out. Skin was white. no difficulty in breathing. as time passed patient improved . ems had arrived and released patient into parents care appoximately 15 minutes later
received an expirated dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E40, expiry date 1st October 2021) for prophylaxis.   On 8th October 2021, the patient received Boostrix. On 8th October 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Medical assistant reported that a patient received a boostrix (single dose vial) dose which was expired on 1st October 2021, which led to expired vaccine used. The reporter consented to follow up.
pt recv vax 3/18/98; in 12/1/98 pt was dx w/autism; mother believes autism is related to vax; however; the physician does not;
Patient woke up with severe arm pain. He ran a temperature of up to 102 and he was experiencing  chest pain.
Flu shot was administered in the tricep area intramuscularly broke out a large reaction from elbow all the way up to back of deltoid. MD rxed AUGMENTIN for reaction/infection.
pt recv vax NOV95&devel body aches,& a fever a few days later;no other info is abominable;
Profound fatigue; Nausea; Loss of appetite; Night sweats; Dizziness; Not feeling well; Booster; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 at 15:30 as dose 4 (booster), single (Lot number: J9943) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "GERD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "SADD" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FC3592, Location of injection: Arm Right), administration date: 09Sep2021, when the patient was 76-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Apr2022 at 15:30, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 06Apr2022 at 15:30, outcome "unknown"; DIZZINESS (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering", described as "Loss of appetite"; NAUSEA (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; NIGHT SWEATS (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; MALAISE (non-serious) with onset 06Apr2022 at 19:30, outcome "not recovered", described as "Not feeling well"; FATIGUE (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering", described as "Profound fatigue". Therapeutic measures were not taken as a result of fatigue, nausea, decreased appetite, night sweats, dizziness, malaise.  Additional information: The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had not COVID prior vaccination and was not COVID tested post vaccination. known allergies: Yes. Reported Event: 3 hrs. after receiving dose began experiencing, symptoms lasted until 1pm today at that time they started to subside. Patient reported "it is 5pm 07Apr2022 and I am still not feeling well".  No follow-up attempts are possible. No further information is expected.
Muscle aches to groin and knee, worsening muscle aches yesterday, fatigue and weakness. Referred to primary provider if symptoms worsen. Patient has appt with provider next Wednesday.
I was out of work for 2 days unable to move I was incontinent of my bowel and bladder. Fever of 101 body aching, Severe headaches with vision loss on my left side severe back pain. Brain fog, dizziness, mental issues worsening. My headaches and vision issues on my left side, brain fog, back pain, dizziness, and my mental health issues has worsen. I fell as well on November 30th which is not like me because of dizziness and vertigo that has started since the vaccine.
I experienced tinnitus ear ringing and pulsating of the ears out an hour after receiving the Moderna vaccine . I have a hard time sleeping and functioning because of the constant ear ringing and pulsating. I have seen ENT several times and now an audiologist to do further testing .
This child had swelling, erythema, tenderness, and itching of the right upper arm. Given Benadryl and Hydrocortisone.
Tinnitus, no treatment, still have tinnitus almost 8 weeks later since onset
Pt believes that COVID vaccine caused Shingles. Pt received Moderna COVID 19 4/16/21. Shingles rash erupted on 4/20/21. Pain to head, neck, shoulder intense. He may get 2nd vaccine if feeling well by then.
Pain in left arm only able to take half breath. Sharp pain if more taken. Tender arm. Red hot spot with lump. No fever.
3 wk after vaccination pt had acute paralysis of upper and lower extremities, required intubation & ventilation, and hospitalization. Pt also had severe pain in (L) arm immediately after vaccination.
Breakthrough case admission after 2 vaccines  Pfizer 5/1/21 Lot# Ew0176;  Pfizer 5/22/21 Lot# Ew0179
Patient had several visits to the ED where they were subsequently hospitalized; on 1/28/2021, 2/18/2021, 2/22/2021, and 4/6/2021. These visits were for alcoholic intoxication and occurred within 6 weeks of receiving COVID vaccination. Patient received second dose on 3/18/2021.
This spontaneous report was received from a licensed vocational nurse refers to a female patient of unknown age. On 13-SEP-2012, the patient was vaccinated with ZOSTAVAX (lot # reported as 0071AE, expiry 03-APR-2013). No concomitant medications were reported. On an unknown date, the patient's arm became swollen and redness around the injection site was about the size of an orange. Patient also experienced tenderness. Patient sought medical attention by visiting the physician's office. Patient received treatment with prednisone. The outcome of the events were unknown. The relatedness for the events was unknown for ZOSTAVAX. Nurse requested for lot # check and requested result of the lot # check sent to the office. This is one of the several reports received from the same reporter. Additional information has been requested.
"Moderna Arm " Painful, warm, red, swollen upper arm, near injection site and distally covering 1/3 of upper arm. Fever, body aches, generally unwell
Patient received pneumonia vaccine and right arm, red, warm to touch, pain, and large welp in vaccine site.
Became hoarse shortly after vaccination within 1hr. Instructed to notify PMD. Saw PMD same day, stated he "looked okay"; gave BENADRYL q 6hrs that day & following day. Hoarseness got worse next day, called PMD & gave breathing treatment BID. Mom states he's doing better today.
Pt reported she felt like her throat was tightening. No airway compromise or dyspnea reported. Vital signs stable. BP 109/65, HR 73, spo2 99%. 50 mg PO Benadryl given at approximately 0750. Patient stayed at the clinic for approximately 1.5 hours. Upon leaving, she reports she felt better and throat tightening had resolved. Vital signs 109/73, HR 68, spo2 100%.
pink rash on her stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (pink rash on her stomach and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 828L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concurrent medical conditions included Diabetic. Concomitant products included HYDROXYCHLOROQUINE for Arthritis, EZETIMIBE, SIMVASTATIN (VYTORIN) for High cholesterol.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (pink rash on her stomach and back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form. At the time of the report, RASH ERYTHEMATOUS (pink rash on her stomach and back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wants to know is it safe for her to get vaccination as she is Diabetic and having Arthritis.
Within 7 hours post vax, the infant developed tachycardia. She was taken to the local ER and hospitalized for observation. She recovered and was discharged.
Erythema at injection site, Injection site pain, Pruritis, Swelling at injection site, Urticaria > 100mm or >10cm  Disorientation, Dizziness, Headache, Lightheadedness, Weakness, Myalgia  Nausea, vomiting Fatigue, Headaches, Nausea and Vomiting, Rash significant, prevents daily activity
Patient tested positive for COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient tested positive for COVID-19) in a 75-year-old female patient 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) (Intramuscular) 1 dosage form. On 24-Sep-2022, the patient experienced COVID-19 (Patient tested positive for COVID-19). On 30-Sep-2022, COVID-19 (Patient tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2022, SARS-CoV-2 test: (Positive) Positive. On 30-Sep-2022, SARS-CoV-2 test: (Negative) Negative.         Patient received booster dose.  Concomitant medications were not reported.  It was reported that patient seeking location to receive his moderna bivalent booster, and was having hard time finding a location in their area. During the conversion, patient stated that she would have to wait 90 days as she was tested positive for Covid.  Lot numbers to moderna primary and boosters were unknown.  Patient did not seeked medical care (office visit, Urgent care, ER, hospitalized).  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660012:MOD22-026797(husband Case)
Large local area. Swelling (12x8 cm) and redness. Warmth, very tender. It happened last year also (2015) after the flu shot.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant patient" (unspecified if ongoing), notes: Kidney transplant patient; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CYCLOSPORINE; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; PREDNISONE; LABETALOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: neg test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
BODY ACHE; CHILLS; FEVER; HEADACHE; EXTREMELY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, chills, fever, headache, and extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache, headache and extremely tired was not reported. This report was non-serious.
02/18/22 presents for EC ED for "left hip pain". PMHx of "diabetes, hypertension, psoriatic arthritis, brain abscess with possible intracranial hemorrhage"
Pyrexia; erythema Information has been received from a registered nurse concerning a 8 year old female with asthma who in late October 2005 was vaccinated SQ in right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #not provided). The patient was given a flu shot (unspecified) in the same arm as pneumococcal 23v polysaccharide vaccine. Twelve hours post vaccination the patient developed a 103 F fever and erythema. The fever persisted for 12 hours. The patient was reported as recovered. There was no product quality complaint involved. Additional information has been requested.
no adverse event; improperly stored and administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 21-OCT-2020, the patient was vaccinated with an improperly stored 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R009614, expiration date 30-NOV-2020 for prophylaxis (exact dose, dose #, route of administration and anatomical location were not reported). The temperature excursion was 50.3 degrees Fahrenheit (F) for 4 hours and 4 minutes. There were no previous excursions reported. The digital data logger was involved. No other adverse events were reported.
pt recvd vax & the following day pt c/o migraine & exp nausea & dizziness; No further details were provided;
Extremely swollen lymph glands under the left armpit. Extreme stiffness and pain in the left and right elbow with the majority of discomfort on the left side. This has not resolved on the left side while some improvement has been made on the right. OTC pain medicine is ineffective. I have been prescribed one round of menthyleprednisone 20 MG once a day for five days to combat inflammation with no long term effect. I still have the stiffness and pain and am losing the grip strength in my left arm.
Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        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.   Concomitant medication was not provided by the reporter.  The treatment information was not provided.
Body aches, slight fever of 99.4 degrees F, fatigue for 24 hours. Vivid dreams for 2 weeks. Soreness in arm that received vaccine for 4 days.
Pt reported palpitations under left arm no chest pain.  O2 sat on room air is 98-99%.  2nd set of vitals; 125/95, p-86, Vital signs unchanged but patient continues to report pain to left axillary area, She was taken to the Emergency room for follow-up.
hyperpyrexia-temp 105 12hr post vax adm to ER-no response to control temp;
Tingling all over, itching all over, shortness of breath, cough due to shortness of breath
Information has been received from a licensed practical nurse concerning an 8 year old male with allergies to Suprax and sulfa who on 10/20/1997 was vaccinated with varicella virus vaccine live. On 02/24/2002, "after exposure to wild VZV," the pt developed a fever for 24 hours and 5-6 vesicular lesions. Follow-up info indicated that the pt developed chickenpox on 02/24/2002 and subsequently recovered. The pt was not seen in the physician's office for his experience. No further info is available.
Have  redness on the skin about the size of a fist around the injection  site.  Started about 5 hours after injection and the nurse noticed some inflammation immediately upon injection.  Definitely itchiness also.  3 days  later still have the redness.  Suggestion may be this booster should have been in a different arm than the other two shots?
Syncope and collapse (ICD10-R55). 17 y/o male who received vaccines being HPV the last one given of 3 on DOS. Pt felt light headache, body was stiff and collapsed. He was somewhat disoriented, pale and clammy, he was assisted to the bed laying down with legs held high. BP 113-43, HR variation 30s-50s at 3:45 PM; pt oriented and conscious at this time. Repeat BP at 4:00 PM 121/67 HR 55. EKG showed NSR with rate variation. His O2sats were in the 80s, w/supplemental Oxygen 8 lpm, sats up to 100%. O2 decreased to 6 lpm with sat still at 100%. Pt had 2 other HPV vaccines with no reaction. Pt continued alert and oriented, HOB raised at 45 degrees. BP at 4:12PM 123/64, HR=51 O2sat=100%. O2 removed at 4:16 PM O2 sats holding at 99% on RA. BP at 4:19 pm 108/77 with HR=64(sitting). BP standing at 4:22 PM = 109/47 with HR=63. Pt continues A/O X3. No neuro deficits; taking for a walk with no complaints; taken back to room BP at 4:25 PM = 101/35 HR=60. Neuro-exam = No deficits. Pt denies headache, dizziness, chest pain, sod, doe, vision changes, paresthesias. BP checked again = 106-56, HR=61. Pt referred to Dr, Pediatric Cardiologist. Pt currently not clear for sports, no PE or strenuous activities until cardiac evaluation. Strict ER precautions d/w patient and his fatherin any significant headaches, dizziness, disorientation, lethargy, difficult breathing, chest pain. 09/26/19=F/U on vaccine reaction. Pt denies any symptoms since 09/25/19; has an appointment with Ped. Cardiologist, Dr next week.
Information has received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-NOV-2016, the patient was vaccinated with expired ZOSTAVAX expiration date 07-JUL-2016; lot #, dose and route unknown for prophylaxis. No adverse symptoms reported. Additional information has been requested.
Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min, pt reports sore, pruritic throat, hoarse voice, difficulty breathing. Pt administered her own EpiPen and received a nebulizer treatment before transfer to ED. At ED, minimal residual symptoms but received prednisone and prn diphenhydramine.