chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Five doses of the Jynneos vaccine were administered beyond-use date; The Jynneos doses were stored in the fridge beyond the eight weeks; Case reference number US-BN-2023-001739 is a spontaneous case report initially received from a physician (reference number: EUBAV23-1815) on 01-Nov-2023 and concerns five patients of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified dates, five patients were vaccinated with a dose of Jynneos (batch number: FDP00020) at an unknown dose, route or site of administration, for unknown indication. As reported, the five doses of Jynneos were administered beyond-use date, the doses were stored in the fridge beyond the eight weeks and there were five patients involved (explicitly coded as 'expired vaccine used' and 'product storage error').  At the time of this initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  Additional information received on 01-Nov-2023 included local case ID.; Reporter's Comments: This case concerns five patients (of unknown demographics) vaccinated with doses of Jynneos stored in the fridge beyond the eight weeks and beyond-use date which is considered as expired vaccine used and product storage error. Expired product administered and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns five patients (of unknown demographics) vaccinated with doses of Jynneos stored in the fridge beyond the eight weeks and beyond-use date which is considered as expired vaccine used and product storage error. Expired product administered and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sudden deafness left ear. Given Prednisone and Valtrex. Little improvement. 60 Day Follow up: deafness left ear veritso. Information from medical records states fatigue, roaring in ears. msv. 12/31/09 Ongoing hearing deficit-Deaf in left ear, partial hearing loss right ear.
swelling in the arm; This is a spontaneous report from a contactable consumer reported for a female patient (Sister-in-law).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and Expiration date was unspecified) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On an unspecified date, patient experienced swelling in the arm that needed to be treated with compression. Outcome for the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
the patient/parent was dishonest while filling out the consent form.  and the patient is actually only 11 years old and not the approved 12 years old for the pfizer vaccination.
Patient presented to the ED with shortness of breath, chest tightness, nausea, vomiting, cough, diarrhea, and fever. She tested positive for COVID-19. She is found to be in Afib with rapid ventricular rate. She was admitted for concerns for sepsis, pneumonia, and metabolic derangement.  She was discharged 3 days later in stable condition.
Pt reported she had redness and swelling at the site that started the evening she received the vaccine. Pt states she also became nausea and dizzy. These symptoms lasted approximately one week.
Fever; Severe headaches; cold sweat; joint and severe muscle pain; joint and severe muscle pain; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 at 14:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Public Health Clinic/Administration facility. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. Medical history includes high blood pressure (HBP), diabetic. The patient received unspecified concomitant medications. On 26Jan2021 the patient experienced fever, severe headaches, cold sweat, joint and severe muscle pain. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment medication for headaches. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  The information on the lot/batch number has been requested.
Patient has reported sensitive skin, headache, sore throat, and nausea since the vaccine.
NO SLEEP; CHILLS; MUSCLES ACHES; HEADACHES; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced muscles aches. On 23-MAR-2021, the subject experienced headaches. On 23-MAR-2021, the subject experienced sweating. On an unspecified date, the subject experienced no sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and muscles aches on 23-MAR-2021, had not recovered from headaches, and sweating, and the outcome of no sleep was not reported. This report was non-serious.
No other AE; Second Dose Administered Too Early / Second dose of VAQTA that was administered 3 months early to a 15 month old. The first dose was administered at 12 months; This spontaneous report has been received from a physician, concerning a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date in 2023, when the patient was 12-month-old, was vaccinated with the 1st dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, and no symptoms were reported. On 06-JUL-2023, when the patient was 15-month-old, he/she received the 2nd dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, administered as prophylaxis (lot numbers, expiration dates, routes of administration, and anatomical location were not provided). This 2nd dose of hepatitis a vaccine, inactivated (VAQTA) was administered 3 months early (Inappropriate schedule of product administration). No other adverse event (AE) was reported.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PATIENT IS IMMUNOCOMPROMISED AND IS ON METHOTREXATE FOR RA AN D HAS COVID AND SHINGLES IN DECEMBER 2022, PT WANTED SHINGRIX 1ST DOSE AND AFTER SHE GOT SHE SAID SHE HAD A RASH AROUND SITE OF INJECTION AND RASH THAT LOOKS LIKE SHINGLES SHE WAS CHECKED BY MD AND HE SAID IT IS FLARE UP DUE TO HER DECEMEBER CASE BUT SHE IS FEELING BETTER AND NO FURTHER ACTION NEEDED
pt received injecton and immediately he advised it was alot more pain the the last one. Said he felt alittle dizzy but said he felt he could make it to chair.  On the way to chair  walking with RN on one side and father on other side pt had a sycopal episodes. legs gave way. EOA was a few feet away and assited pt to cot. directly upon being laid on cot pt was A&Ox3, V/S  B/P 90/60, pulse 78,  02 sat 98%. at that time stated he remember getting dizzy following the painful injection.   Father, mother and sister all have this same reaction when receiving injections. Pt observed for 30 min no problems noted. denies any problems. Pt sat on end of cot. Denied any dizziness. stood up no problems V/S retaken 90/70, pulse 84,  O2 sat 98%,  Instructed mother good idea to take to primary MD for check up.  Pt stable released home.
Sore axilla neck, side of vaccination swollen neck. Unilateral numbness tingling of jaw, side of vacc. Resolved within 12 hours. Upper arm numbness, tingling at night when sleeping on side of vacc.-continued six days.
12 hours post vaccines patient has temp of 104. 3 days later present with reddened induration over thighs with fever. Next day fever resolving as well as red area.
Local swelling, redness, and pain. Sensation at base of neck and along her clavicle.
This healthy 22 year old reported receiving his primary Smallpox vaccination on 18 Feb 2006.  He reported experiencing typical flu like body aches and pains with a frontal headache (3/10 pain scale) the first week that resolved with use of Tylenol and rest. He stated his smallpox vaccine site had a "typical" reaction he was told to expect with the scab falling off about day 21-28. However after resolution of his "flu-like" symptoms he never "felt right".  He is unable to describe other than he just felt different.     On 10 April 2006 he reported to the reserve center where he noted he was unable to urinate.  He was sent to the hospital where he was catherized and admitted for evaluation. He also noted increased sensitivity to his right side (arm, abdomen, back) and to both legs with associated numbness and tingling.  He reported over the next few days he was nauseated, has 1-2 episodes of vomiting preferring not to eat due to feeling ill, and was "unable to walk as his balance and gait were off". To walk he required the use a cane and used the wall for support. He denied any pain, paralysis, shortness of breath, bowel incontinence/constipation, weakness to upper extremities or change in behavior/mentality. He was diagnosed with ADEM and treated with IV antibiotics, steroids and IVIG with resolution of these symptoms within a few days (bladder and gait problems).  He was placed in physical therapy for muscle retraining and strengthing and complaints of lower back pain 1-4/10.  On 11 April 2006 doctor consulted and referred this service member to the Vaccine Healthcare Center.     He contacted Vaccine Healthcare Center on 4 May 2006 upon returning home. He reported he was "almost normal" as he continues to have numbness and tingling with hypersensitivity to the skin along his right side (forearm and abdomen). He has no difficulty urinating and has full use of all extremities. He can walk without difficulty. He denied any shortness of breath, abdominal pain, incontinence/constipation/retention, or erectile dysfunction.  He does admit with questioning to some "fogginess" in his brain when answering questions. He described this as a delay in answering questions he wasn't aware of prior to his diagnosis of ADEM.
pt had pain after injection.  at midnight that same day patient experienced tingling, electrical sensation shooting down the arm to the finger (index and thumb) for over a month.
My first vaccine was on 16 Jan. 2021. I had bad headaches for two weeks.
Within 15 minutes of vaccine the injection site started to itch and swell. Within 60  minutes the back of my throat started to itch, the injection site was hot, red, swelling area 3" x 3" with a raised margin of 0.25 inches on 2 sides.  I went swimming (swam gently) in the Sound as it was cool salt water.  My arm continued to become inflamed (red, hot, swollen, itchy) spreading to my shoulder and down to my elbow.  I took a Benadryl before bed.  I spoke with the pharmacist at 4 pm the next day who suggested taking ibuprofen to reduce the inflammation.  I could not continue to take the Benadryl during the day since I had to drive.  I took one again at night along with the Ibuprofen.  I also iced my arm every night.  in 24 hours my arm was hurting with the heat and pressure.  It felt like it was inflamed to the bone.  The inflammation was wrapped around all but 2 inches under my arm.  By Friday am it was not hot nor as red.  It remained itchy until Monday.  I used a topical hydrocortisone.  As of today, 9.22 the itchy feeling has mostly subsided.
sore, itchy left arm with red swollen circle around injection site appeared 7 days post vaccine; arm sore since injection; no current treatment
19APR93 mom observed generalized rash over entire body, pt scratchy; has no fever; feet forearms/little puffy;
Dose received: 3; I have weakness in my left arm; I still feel the pinching as though the needle is in my arm; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 64-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 04Nov2021 at 13:00 (Batch/Lot number: FF2587) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Thyroid cancer" start date: an unknown date in 2017 (unspecified if ongoing) and "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; CARVEDILOL; LEVOTHYROXINE and OMEPRAZOLE. Past drug history included: Levofloxacin, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: ER8733, Anatomical site: left arm, Administration time: 11:00, Route of administration: unspecified), administration date: 29Mar2021 and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EN6203, Anatomical site: left arm, Administration time: 11:00, Route of administration: unspecified), administration date: 05Mar2021, both when the patient was 63 years old, for COVID-19 immunisation  The following information was reported: MUSCULAR WEAKNESS (non-serious), PARAESTHESIA (non-serious), with onset an unknown date in Nov2021, outcome "not recovered" described as "I have weakness in my left arm, I still feel the pinching as though the needle is in my arm". Therapeutic measures were not taken as a result of muscular weakness and paraesthesia.   Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Flublok was used for 7 year old child with no adverse event; Flublok was used for 7 year old child with no adverse event; Initial information received on 17-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old child of unknown gender for whom it was reported that flubok is used for 7 year old child with no adverse event while receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  First time vaccine used was reported as no.  On an unknown date, the patient received a  dose of suspect Flublok Qiv vaccine (form, strength, administration site, route,  lot number not reported) for immunization. Information on batch number was requested.  On an unknown date it was reported Flublok was used for 7 year old child with no adverse event (Product administered to patient of inappropriate age) (unknown latency) and Flublok was used for 7 year old child with no adverse event (product prescribing issue) (unknown latency) following the administration of Flublok Qiv.  Action taken was not applicable.  Outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  00971589:related
Transient diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 85-years-old female (not pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no and expiration date was not reported), via unspecified route of administration in left arm on 09Mar2021 at 12:30 as 1st dose, single for COVID-19 immunization (at the age of 85-years). Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took bactrim and experienced drug hypersensitivity. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. On 10Mar2021 at 10:00, the patient experienced transient diarrhea. The patient did not receive any treatment for the events. The clinical outcome for the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 19-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER5727), at the age of 19, intramuscularly, on Mar 28, 2021, single dose, for COVID-19 immunisation. Medical history included non-smoker (unspecified if ongoing); and abstains from alcohol (unspecified if ongoing). Patient has an allergy to morphine (unspecified if ongoing). Concomitant medication included adalimumab taken for Crohn's disease, start date: Feb 9, 2021 (ongoing). The patient experienced depressed mood, panic attack/recurring panic attack and crying, onset Apr 1, 2021, with outcome of not recovered. Additional Information: It was unknown if patient was enrolled in a COVID-19 vaccine trial. No follow-up attempts possible. No further information expected.
Lip swelling, tingling, numbness, tongue throat tightness, hives, within 10 min. Chest tightness over next 12 hours intermittent hives. In evening-fasciculation BLE calves and thighs.
Approximately 20 min after administration of vaccine, patient developed large raised erythematous welt at injection site accompanied by wheezing, symptoms of wheezing relieved with albuterol inhaler. Generalized itching began about 20-24 hours after injection not completely relieved with antihistamines.
New onset seizure like movements after receiving vaccines. 2 Atonic events lasting 1-2 minutes with associated peri-oral cyanosis. 1 tonic-clonic event lasting 1-2 minutes.
Extreme dizziness and nausea immediately following injection, lasted for over an hour.  After 10 minutes following injection a strong wave of nausea started in pit of stomach and moved up through abdomen to chest, then felt moderate chest pressure and warmth, lasting about 3-5minutes. Blood pressure was 177/110 and pulse was 138 approximately 15minutes following injection and sustained this high for another 20minutes.  After an hour of observation, went home and experienced significant exhaustion and drowsiness.
Swollen and painful lymph node under armpit on left side only following day that was swollen and sore for 5 days. A little less each day. Very tired and all over muscle soreness and weakness the following day after injection for about 1 1/2 days total. Slight nausea the following day after injection. No fever. *I believe I had Covid, but was not tested, in mid-March 2021.  Loss of taste and smell for a week and had major muscle pain, weakness and tiredness for about 3 days.
Approximately one week post vax pt developed a rash over the body and a fever up to 103.5.
fever, fatigue, bodyaches, headache Narrative:  Took Cimetidine and Tylenol with Codeine. Had Humira injection on 1/1/2021
Woke from his nap and complained of his leg hurting. Could not bend it at the knee on the leg of the injection site, thigh was swollen and hot to the touch. Developed a low grade fever (101) on 12/25/14 at noon.
Rash on chest 3 days after administration. Rash was clustered only in this area.
This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot # and expiration date were not reported). On an unknown date, the patient experienced rash in an unspecified area of the body. It was unknown if the patient sought medical attention, received any treatment or if diagnostic laboratories were performed. At the time of reporting, the outcome of rash was unknown. The causality assessment was not provided.
7/27/11 - 1/2 dollar size red area, swollen, heat, painful to touch. Itches, pts mom stated pt had not taken any medication. Pt came to HD, advised to take 600mg Ibuprofen and if not better by Friday to come back. 7/28/11 phone call from pts mom stating area spread and pt had HA and ill to stomach. Pt came to clinic and seen by MD who advised to go to ER. 8/2/11 I called pt, she did not go to ER but stated she is fine and it went away on 7/30/11.
pt recvd vax 14JAN93 & 26JAN93 pt devel a rash; No further details were provided;
About 12 days after I received the booster shot, I broke out in hives all over my body, face, hands and feet. This is the first time I have ever experienced hives. I immediately went to an urgent care where I was prescribed with prednisone 20mg for three days for the inflammation and swelling. However i am still experiencing random flare-ups of hives. After seeking a second consultation, a primary physician advised me that this could be an adverse reaction to my booster shot. I have never experienced any type of adverse reaction to any vaccine before.
RESIDENT PASSED AWAY ON HOSPICE SERVICES ON 12/8/2021. HAD BEEN ON HOSPICE PRIOR TO VACCINE BOOSTER.
Arm sore and muscles tighten up. Can't bend or move arm since flu shot.
Pt admitted to hosp on 26APR91 w/t102, & bulging fontanel; CSF culture done 26APR91 cultured out Beta-Lactamase positive-H.Fluenzae; Organism was resistant to Ampicillin & PCN; Pt previously admitted to hosp for orbital cellulitis @ 2.5mo;
Onset fine macular rash on upper chest wall and upper back, bilateral arms and small amount on abdomen. First noticed on 4/5/00 in the AM. Swollen gland rght anterior cervical.
Itching all over body, rash that looked like welts all over body, lightheadedness, fatigue.
Loss of taste.  It started with my coffee tasting like water and currently I can only taste the heat affect of spices while eating.  No treatment.  Not getting better.