chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had headache ever since and has not gone away and its barging on migraine territory.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Lot number: ER8736) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), when the patient was 32 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "I had headache ever since and has not gone away and its barging on migraine territory.". Therapeutic measures were not taken as a result of headache.  Additional information: Further stated that patient called to report a possible side effect. He just recently got my second dose of vaccine. It was about week and a half, he had headache ever since and had not gone away and it was barging on migraine territory."   No follow-up attempts are possible. No further information is expected.
runny nose; headache; chills; shivering; ice cold hands; nauseau no treatment yet
Soreness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the vaccination site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the vaccination site). On 14-Jan-2021, VACCINATION SITE PAIN (Soreness at the vaccination site) had 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.   Treatment for the event as reported, he was going to take ibuprofen for the pain but forgot.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
4 days p/inject, raised, erythematous, warm lesion around inject site; pt states painful & pruritic;
stiff fingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff fingers). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff fingers) 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 concomitant medications were mentioned. No treatment details were reported.
body aches, shivers, tired active symptoms; began at 2 p.m. 1/27/22
ER Hospital on 9/14/2021 ER Hospital on 12/20/2021 ER Hospital on 12/03/2021 ER Hospital on 12/27/2021 through 01/03/2022 Covid-19 (Mrna) Vaccine (Pfizer) Guillian-Barre Syndrome, ascending paralysis syncope and L hand painful thumb
Swelling in armpit lymph node on left side where shot was given, muscle where injected is caved in like if the medicine killed muscle fibers off once the swelling went down, this was the worst of the three vaccines. The fever body aches chills fever were terrible. Went away within a days time, but injection site was swollen and red for approximately 6 days. After that, muscle tissue in the area is missing and skin lost some sensation to touch compared to the rest of my upper arm surrounding the injection site.
Shingles; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event(s) shingles.  Treatment details included valacyclovir.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shingles was unknown.
On day 7 after first dose of Moderna, injection site has a bumpy, itchy rash the size of a quarter.
Narrative:  60 yo male patient who was already hospitalized for another medical issues received the COVID vaccine (first dose). He developed dyspnea, was monitored, and symptoms resolved. Was given dose 2 of the series without issue.
pt recvd pneumococcal vax in lt deltoid 8 hrs p/inject  & noted to have a pinpoint red rash on chest, arms, & legs
24 hours after the vaccine I had a 102 fever overnight.  The next day, my feet were hurting, like burning.  They continued like this but with fluctuating severity.  My calves and shin muscles began to be sore.  I sought out acupuncture and myofascia release work to help.  It did help temporarily.  I started to have left ankle pain, not like a sprain, like tendonitis or inflammation.  It continued to hurt to walk and the muscles more painful.  I started having darker urine about 4 days after the vaccine.  I drank cranberry juice and took a kidney/bladder supplement, increased fluids, but it continued dark.  I went to the Urgent Care on January 7th c/o muscle pain and dark urine.  My blood pressure was elevated, 179/100..unusual for me, and my urine was neg so it was sent for culture and blood was drawn for CBC and metabollic panel and Creatine Kinase
pain, swelling, warmth and redness at injection site; pain, swelling, warmth and redness at injection site; warmth; redness at injection site; This is a spontaneous report from a contactable consumer (patient).   A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm left on 05Oct2021 19:15 PM (Lot number: FF8841; Expiration Date was not reported, at the age of 41-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history included migraine headaches; activity induced asthma. Concomitant medications included unspecified medications in two weeks. The patient did not receive any other vaccine in four weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via unknown route of administration in arm left on 10Feb2021 (Lot number: EL9269 and Expiration Date was not reported) and dose 2 via unknown route of administration in arm left on 03Mar2021 07:15 PM (Lot number: EN6201and Expiration Date was not reported), both at the age of 40-year-old for COVID-19 immunisation. The patient also took acetylsalicylic acid (ASA) in high doses before and experienced allergy. The patient had no Covid prior vaccination and had not tested Covid post vaccination. The patient experienced pain, swelling, warmth and redness at injection site several days after Injection on 07Oct2021. She had no fever. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient got the expired Covid vaccine (vaccine expired on 02/12/22). No ADEs is reported
This case was reported by a nurse on behalf of an immunologist, and described the occurrence of double sterile abscesses in a 4 to 5-month-old male subject who was vaccinated with Pediarix, or Infanrix plus Engerix B for Prophylaxis. The nurse stated that it was uncertain whether the subject was vaccinated with Pediarix or alternatively with Infanrix Plus Engerix-B, but stated that the manufacturer was known. On 07 March 2007, the subject was also vaccinated with Hib vaccine (manufacturer unspecified) and Prevnar. On 7 March 2007 the subject received his "four month" vaccines including unspecified dose of Pediarix (unknown, unknown thigh), or unspecified dose of Infanrix (unknown, unknown thigh) plus unspecified dose of Engerix B (unknown, unknown thigh). In 2007, at an unspecified time after vaccination with Engerix B - Infanrix or Pediarix, the subject developed double sterile abscesses. Following vaccination on 07 March 2007, the subject developed a hard mass on both thighs and a "large local reaction". The subject subsequently developed infection, and the areas became "raised, red, and almost puffy". On 28 April 2007 the subject was evaluated by a pediatric surgeon, who reportedly felt the reaction was related to the vaccinations. The abscesses required surgical intervention, and were removed. The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional stated that the pediatric surgeon considered the events were related to vaccination with Pediarix, or Infanrix plus Engerix B. The healthcare professional also stated that the double sterile abscess were unrelated to vaccination with Pediarix, or Infanrix plus Engerix B.
25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation). At the time of the report, ACCIDENTAL UNDERDOSE (25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 81-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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No Treatment medication reported.
Left shoulder bursitis and pain Recommended ice and movement, topical pain creme, if not better in a week from visit may consider steriod injection or orthopedic consult.
Crossed linear redness to vastus lateralis. Area does not appear to bother patient. No fevers.
13JUN96 fever 103.3 started & diarrhea;14JUN96 t102 diarrhea cont small bumps under skin gen no color to bumps;15JUN96 99-100;gen pink rash, crying lasting for <3hr, took to immed care MD started on med 16JUN96;loose stools;
Pt did not have an adverse reaction to the vaccine. However, while the Immunizer is injecting the vaccine, he felt resistance in the muscle and stopped advancing the needle, therefore the needle was about 3/4 in inside the tissue. When the immunizer advance the vaccine, he noticed it started leaking out of the site. The immunizer then withdrew the needle from the patient and discarded the syringe with the left over vaccine. Per the immunizer's report, the patient did not receive the entire 0.3ml of vaccine, it is unknown how much the patient received. The patient was made aware of the incident on the spot and was taken to the clinic to be assessed by a medical provider. A patient safety report was submitted and PFIZER was contacted about the event. Per PFIZER representative, since the patient did not receive the entire 0.3ml dose, it has been recommend that the patient repeat the 1st dose 0.3ml of vaccine. Pt was notified the following day and did not report any adverse reaction; he has agreed of the plan per PFIZER's recommendation. Pt will be is scheduled to receive his 1st dose on 19 FEB 2021.
Extreme pain in lower right back and upper right neck.  Within 2 day pain progressed to lower left back and upper right neck.  Upon waking from sleep at any time during the day or evening cannot move without extreme pain.  Yesterday, 1/20/2021, I called my doctor's office and did a call.  Doctor prescribed Baclofen 10mg for lower back pain.  It has provided little relief.  I question what else can be done to alleviate the pain and, also, whether I should go for a second shot on Feb 12.  I told the Doctor it feels like a kidney infection I had in my teens but she dismissed that.
Woke up with a bad cough on Saturday (vaccine was prior Wednesday).  Says he feels fine, but has a bad cough and a sore throat.  Also slight runny nose.
Patient received the 12+ year old dosing of Pfizer Bivalent COVID Vaccine instead of the pediatric dosing.  No adverse effects noted.
fever; chills; fatigue; This is a spontaneous report from a contactable consumer.   An elderly female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and the patient's concomitant medications were not reported. The patient had received the first dose of vaccine on unknown  date for covid-19 immunization. The patient experienced fever (non-serious) on an unspecified date with outcome of recovering, chills (non-serious) on an unspecified date with outcome of recovering, fatigue on an unspecified date with outcome of recovering. The patient underwent lab test which included body temperature: increased.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
Patient is fully vaccinated and boosted on 10/2/2021.  COVID + 1/18/2022. 25-year-old female with a past medical history of GERD, peptic ulcer disease presented to the hospital with nausea and vomiting getting worse. CT abdomen and pelvis showed no acute abdomen or pelvic abnormalities and had a nodule in the lingular left lower lobe consistent with infectious process.Not a candidate for any Decadron or remdesivir, was able to tolerate diet without any complications.  Electrolytes replaced.  Hydrated. Discharged on 1/19/2022.  Readmitted on 1/20/2022. Patient admits to continuous vomiting, abdominal pain, chest pain.  Patient also admits to sore throat, denies drooling or difficulty in swallowing. Positive for shortness of breath. CT abd/pelvis with no acute process.  CXR: no acute process. Discharged with GI consult.
This serious spontaneous report (initial receipt 05-Dec-2014) concerns an unknown patient. On an unspecified date, the patient received AFLURIA injection (batch number not provided). On an unspecified date, following the AFLURIA administration, the patient experienced Guillain Barre Syndrome (GBS). Outcome was not reported.
Presented to ER with pleuritic chest pain and acute dyspnea.  Her labs on admission were notable for WBC 23.5 with AEC 12.0 and IgE elevated at 1058 LV EF of 25%, Medium sized pericardial effusion with intermediate density concerning for pericarditis. Troponin 5000.  Echocardiogram: small pericardial effusion and biventricular dysfunction with LV EF 25%, likely myopericarditis.  CMR rest w/wo gadolinium showed global LV dysfunction and no evidence of T2 or LGE scar Patient started on 0.6 colchicine BID for treatment of suspected pericarditis given reports of periodic chest pains.  CT chest w contrast: Dense consolidation in the RUL, RML with GGO throughout And patchy consolidation in the LLL with some microdularity with GGO. Significant mediastinal, subcarinal and hilar LN.  Treatment with ceftriaxone and azithromycin
ongoing intestinal difficulties; teeth hurt; ear ringing; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old elderly non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 28Feb2021 at 17:15 (at the age of 73-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease, Hashimotos thyroid from an unknown date. The patient was allergic to gluten and penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021, the patient experienced intestinal difficulties and was only able to have liquid diet for many weeks (continuing). The patient also experienced teeth hurt and ear ringing. The adverse events resulted in the doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included CT scan, blood test on an unknown date. The patient received special diet and medications as a treatment for the adverse events. The clinical outcome of the events abdominal discomfort was not resolved and the outcome of the events tooth ache, tinnitus was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
On the 25th he was home alone, he called 911 and let them know he thought he was having a stroke. EMS arrived and transported him to Hospital. It was massive stroke, he was not able to comprehend anything, he was put into Hospice the following day and passed away on the 27th. There was no autopsy preformed.
Shot was painful; Arm was a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain during injection in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced pain during injection and pain in arm. On an unknown date, the outcome of the pain during injection and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pain during injection and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The patient received the 1st shot and was painful, but her/his arm was a little sore. The information regarding consent to follow up was not reported. For 2nd dose, refer case US2021AMR064344, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064344:same report, same patient, different dose (2nd dose)
When I received the injection I felt a sharp pain go up the side of my neck and along my upper back.  When I awoke the next day, I could not turn my head to the left without pain.
Pt developed regression. Child was developing normally. Started talking and could even sing Happy Birthday and a made up song using her middle name. She sang everybody loves me. The regression was gradual until she lost all language and comprehension ability and all social behavior.
Rash, induration, pain & itching initially at site then, 2-3 days later antecubital fossa on left arm. Finally 1 wk later occurred on left back (shoulder). Treated with BENADRYL & Hydrocodone.
PATIENT CAME TO THE PHARMACY ON 7/14/21 TO REPORT THAT HER RIGHT UPPER EYELID IS RED AND SWALLEN AND ON 7/9/21 HER PHYSICIAN TOLD HER ON VIDEO CONSULTATION THAT IS AN ALLERGIC REACTION TO THE COVID-19 VACCINE.  PATIENT DID NOT SEEK ANY MEDICAL ATTENTION, SHE WAITED UNTIL 7/12/21 FOR HER PHYSICIAN TO MAIL HER EYE DROP (TOBRAMYCIN/DEXAMETHASONE). PATIENT STARTED TREATMENT ON 7/12/21. ON 7/14/21 WHEN PATIENT CAME TO THE PHARMACY TO REPORT  THE INCEDENT, SHE WAS ALREADY GETTING BETTER.
Pt c/o feeling tired, warmth in chest and 2/10 chest tightness. Pt states "I just don't feel right". Pt arrived in med obs @ 09:27 accompanied by wife. Vitals obtained and continually monitored. Pt found to be hypertensive. Chest tightness easing up. No reaction noted at vaccine site. Pt and wife agreeable to being transported to hospital via EMS. EMS arrived @ 0955. Report given to paramedic. Pt left vaccine site @ 0957. Vitals as follows: 0927 BP 210/123 HR 94, RR 20, spo2 98% 0930 Manual BP 205/120 HR 88 RR 20 spo2 98% 0935 Manual BP 210/120 HR 95 RR 20 spo2 98% 0944 Manual BP 190/110 HR 93 RR 20 spo2 98% 0949 BP 199/100 HR 94 RR 20 spo2 98%