chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from pharmacist and refers to a 16-year-old. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 12-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (formulation, route of administration, vaccination scheme frequency, and anatomical location were not provided; lot number WO252273 with expiration date of 02-JUN-2023 but upon internal validation established as W0252273 with an expiry date of 10-AUG-2024 (conflicting information as it was reported that the product was expired)). The administered dose of the vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023. It was not reported if the information was obtained from the data logger or not. There was no adverse effect reported.  This is one of several reports from the same reporter.
Large red lump right lateral thigh  half dollar size Dx: local reaction 2/15/02 by doctor.                    1/2 teaspoon. Benadryl given x 1 still has a bruise half dollar size 2/25/02
11/10 Inflammation of left shoulder, redness, heat, pain.  11/11 Mom observed three small blisters with clear fluid. Continues to have swelling, pain, redness and heat.
She felt well immediately after vaccinations, but began to feel pain on inner left arm several hours after vaccination.  She awoke next morning with marked fatigue, and muscle aches in both upper arms, thighs, lower abdomen, and neck.  She reports no specific fever but "always has low-grade temperature of 99F."   Also reports dysphagia, "like lump in chest after swallowing, that might feel better after vomiting."  She has not vomited and has no specific nausea.  Ate some rice and drank water today without specific problems.  No diarrhea or blood in stool.  No URI sxms.  No SOB or CP, other than the discomfort after swallowing.  No neuro sxms other than diffuse aching pains and fatigue.  She reports similar challenges with achiness and fatigue after prior flu vaccines, although current sxms are more than she expected.  She "avoids vaccines when possible" but is concerned about infections, like flu, and generally receives recommended vaccines.
Information was received from a registered nurse regarding a 5 year old patient (gender unknown). On 26-MAR-2014, the patient was vaccinated with a (Oka/Merck) PROQUAD, lot # H015631, which expired on 23-FEB-2014 (dosage and route of administration not provided). No adverse effect reported. A second patient was also administered the expired vaccine (case #1404USA006598). Additional information has been requested.
3/23/16: Per parent - child was seen at E.R. following "febrile seizure".
got very sick; I cant control my voice; weird quiver in my voice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE taken for infectious thyroiditis. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN.), for Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very sick"; DYSPHONIA (non-serious), outcome "unknown", described as "I cant control my voice; weird quiver in my voice".  Additional information: Patient got sick from 2nd dose like voice control stopped so it had like quiver in it now where it didn't before and first like for 1st week thought oh that's just because patient was sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blood pressure drop right after shot. Symptoms of vasovagal syncope increased over next 36-48 hours (feeling woozy, weak, low BP readings, unable to stand). Nausea and vomiting. Unable to sleep overnight/insomnia. All began right away, worsened over the next 12 hours and interfered with functioning. Began to resolve after 24 hours.
COVID-19; COVID-19; Moderna Dose Number 3 Pfizer / BioNTech Dose Number 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 16:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 at 11:15 as dose 1, single (Lot number: 07821A), in left arm, on 14Apr2021 as dose 2, single (Lot number: 046B21A), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: 051F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Nov2022 at 16:30, outcome "unknown", described as "Moderna Dose Number 3 Pfizer / BioNTech Dose Number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
fever (100.0), chills, severe body aches, headache, urinary frequency, and sore arm x 24 hours, next 24 hours fatigue and sore arm.  by day 3 - feel about back to normal.
PC from Pt's mother 8/22/05. Mother reports child's rt arm is swollen from upper arm to elbow today gradually gotten worse over weekend. Used ice x's. Advised cont cold compress and call PMD for advise. Also reported itching/redness. No fever reported.
It is a tingling unpleasant sensations but not pain or paralysis; it might be associated with that and receiving the shot as it is similar but not the same exact feeling; Inappropriate schedule of vaccine administered; has a nerve tingling on her facial nerve/ developed a facial nerve problem from her ear to her chin; This is a spontaneous report received from contactable. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Lot number: EN6205) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Herpes" (unspecified if ongoing), notes: starting at the age of 22 years old. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot: EL9267, Injection in right arm. , Expiry and not on the card.), administration date: 11Feb2021, for Covid-19 Immunization. The following information was reported: FACIAL NERVE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "has a nerve tingling on her facial nerve/ developed a facial nerve problem from her ear to her chin"; PARAESTHESIA (non-serious), outcome "unknown", described as "It is a tingling unpleasant sensations but not pain or paralysis"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it might be associated with that and receiving the shot as it is similar but not the same exact feeling"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were taken as a result of facial nerve disorder, paraesthesia, feeling abnormal. Additional information: The patient had a nerve tingling on her facial nerve. Facial nerve problem was non-serious. Facial nerve problem is related to COVID vaccine. The patient had the second shot of the Pfizer Covid vaccine about 10 weeks before and in the last couple weeks she has developed a facial nerve problem from her ear to her chin. It was a tingling unpleasant sensations but not pain or paralysis. The facial nerve problem was on the left side. It was remarked by the caller she has had herpes zoster outbreaks in the past and it was usually on the left side, she thought it might be associated with that and receiving the shot as it was similar but not the same exact feeling. The event she thought at first it might be associated with stress. It started she would say around the end of Apr2021 but she ignored it at first. First dose: It was given on 11Feb2021, Lot: EL9267, Expiry and NDC not on the card, injection in right arm. It was given between 8-9 am, for both shot. She takes no prescriptions medication, only vitamins and supplements for the last 50 years. It was several years ago since her last breakout of herpes. She has had maybe dozen in her life starting at the age of 22 years old. Treatment: Yoga. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Underarm and breast tenderness as well as swollen lymph nodes on the same side as vaccination
Irritated Red bumpy rash from base of neck and covering whole face.    Fatigue and sore throat
K92.1 - Gastrointestinal hemorrhage with melena E87.6 - Hypokalemia D64.9 - Symptomatic anemia R10.32 - Left lower quadrant abdominal pain
Patient given Pfizer monovalent dose versus Moderna monovalent dose to complete initial series. No adverse reaction to vaccine noted. Patient remained alert and normal to responses after administration.
Pt recvd 3 doses of Engerix-B vax & it was determined that pt did not seroconvert; 4th dose of Engerix- B was administered;
Evening of 1/28 I started feeling fatigue, muscle aching, stomach upset and headache which lasted till next day around noon.  Then was fine for 7 days.  On 2/5/2021, I went to get my B12 shot and asked the doctor to check left arm where Moderna shot was given as it was itching and a bit sore at the same time.  He told me I was having reaction.  By evening, a third of my arm around injected area was swollen an had red rash.  Then same symptoms of fatigue, etc. came back and I was in and out of bed for the next three days....then at end had a bout of diarrhea.
Sore arm/ left arm tenderness 6 hour vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm/ left arm tenderness 6 hour vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and VITAMINS NOS for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm/ left arm tenderness 6 hour vaccine). At the time of the report, MYALGIA (Sore arm/ left arm tenderness 6 hour vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information provided    This case was linked to MOD-2021-119401 (Patient Link).
swelling on left arm, sore and hard, warm to touch.  swelling got bigger today 10-20-22 advised patient to contact primary care physician  will follow up with patient
Received Kinrix on 6/11/09, IM/L arm.  Mom noted redness + swelling on 6/12/09, arm warm to touch in the upper deltoid area;  good ROM.  Mom reported to office on 6/13, None examined by MD;  significantly decreased symptoms by 6/16/09.
patient was nervous after the injection-stepped out of the immunization room and sat in chair- felt light headed and passed out for about 5 seconds
she did not have a reaction other than a sore arm.; funny taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jan2021 (Lot number: EL9264) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: Verbatim: Diabetic. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she did not have a reaction other than a sore arm."; TASTE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "funny taste".  Additional information: Reported that Concomitant Products Metformin has been taking for several years. She thinks just about everyone takes this who is diabetic unless they are on insulin, no further information provided. Patient did not think this would cause a funny taste.  No follow-up attempts are possible. No further information is expected.
Swelling to (L) upper arm starting the day after Men and Tdap injection; initially was about palm size; taken to ER and started on P.O. KEFLEX, now swelling and redness up to above elbow; not painful to touch but still red and warm.
Red, blotchy face.  Red,  itchy hands.  Hives on hands and forearms.  All began approximately 12 hours after getting the vaccine. All side effects went away within 48 hours.
This spontaneous report as received from a nurse refers to a 8 week old patient of an unknown gender. On 29-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot # K006805 and expiry date: 24-MAR-2016. No adverse events were reported. No product quality complaint PQC was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Came in to see MD today with breakout on face, arms and torso, no fever.  Breakout started 04/13/04. MD diagnosed her with chickenpox.
Severe headache, profound lower extremity weakness (pt too weak to walk), somnolence.
Information has been received from a registered nurse concerning possibly 10 patients who were vaccinated PO with the first 2.0 mL dose of Rotavirus reassortant vaccine live after 12 weeks of age. It was unknown if medical attention was sought. At the time of this report, no adverse experiences were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
fever 102 F; headache; chills; body aches; This is a spontaneous report from a contactable Nurse reported for herself. A 63-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Dec2020 14:30 and the second dose single dose (lot number=EK9231) on 09Jan2021 19:15 for COVID-19 immunization. Vaccine location=Left arm, dose number 1 and dose number 2. Facility-type-vaccine: Hospital. Medical history included asthma. The patient's concomitant medications were not reported. On 10Jan2021 at 14:00 the patient experienced headache with outcome of not recovered, fever 102 °F with outcome of not recovered, chills with outcome of not recovered and body aches with outcome of not recovered. The action taken was not applicable.  Tylenol was received as therapeutic measures for fever.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from an office manager concerning her 16 year old daughter who was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced localized reaction with severe redness and swelling. Therapy with GARDASIL was discontinued. After stopping therapy, the symptoms improved. On an unknown date, the patient was recovered. The patient went to the doctor's office. Additional information has been requested.
I had my flu shot a week prior then my COVID-19 booster. A week later, I started feeling very achy. My normal temperature is a bit lower, so when it hit 99, I was starting to feel hot. I would wake up with that. My skin was hurting, muscles were hurting as well. I started taking Singulair at that time because I was having trouble breathing because it felt like someone was sitting on my chest. I had a runny nose like crazy and that went on. I waited 10 days before making an appointment. They did a strep test, an at home COVID-19 test and both were negative. The doctor gave me a z-pack and I went home. I felt better in about 4 days, then 2 weeks after that, the symptoms came back. They gave me another z-pack. So far, it's been okay and I've been better. I'm still tired but I can't tell if it's the weather because the weather affects my arthritis pretty bad. It was scary when I couldn't breathe well because when I would take a breath, my ribs would hurt and my chest was heavy. My husband and I don't get really go out often and we have been careful. I had another COVID-19 test before my second z-pack and that was also negative. I don't know what this is. In January of 2020,  I was also sick at that time and it was very bad. I went to the doctor and the doctor tells me I had a virus that would last a month or so. I was given cough syrup (heavy duty) and he couldn't tell me what it was. I may have had COVID-19 back then, and it took me 3 weeks to get over it and I could barely get out of bed. It was very strange.
Td vaccine was administered to the wrong pt. Pt didnt have a reaction to the vaccine.
This spontaneous case, initially received from other health professional on 26-Sep-2018 and follow-up received from other health professional on 26-Sep-2018 and follow-up received on 27-Sep-2018 (combinedly processed), concerning a 70-year-old, elderly, female patient. On 26-Sep-2018, the patient was not administered complete dose of FLUAD (TIV) (dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 251354 and expiry date: 30-Apr-2019). It was reported that, the patient was injected with the vaccine PFS and as the syringe was pulled out of patient's arm, the hub detached from the syringe and the needle and hub were attached to patient's arm. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1033688. On an unspecified date in 2018, after the vaccination, the patient experienced injection site pain. At the time of the report, the outcome of the event injection site pain was not reported. The reporter assessed the case as non-serious. Update received on 11-Nov-2018: Non-significant case correction (27-Sep-2018): The term was changed from 'QA reference number' to 'PTC reference number' in notes section of additional information tab.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on 25Oct2018 at a single dose immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose PNEUMOVAX in 2017 (reported a year from the time of the report) for immunisation. On an unspecified date in Oct2018, after the vaccination, the patient reported arm swelling double the size down to the wrist, redness and discomfort. The patient reported that he could not follow-up with the physician who recommended to wrap in ice bandage, apply heat, elevate the arm and take antihistamine. The patient reported that symptoms improved however swelling and discomfort were still present under the arm. Outcome of event 'redness' was recovering; all other events were not recovered. Information on the batch number has been requested.
18nov96- headache, legs  and back ache;20dec96- went to MD for complaints; 22nov96- again went to MD for same complaints & weakness in legs-using walker; 23nov96-went to ER, unable to walk at all; pt admitted; still in ICU 02dec96; GBS
throat closed; diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (throat closed), DIARRHOEA (diarrhea) and HEADACHE (headache) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (throat closed), DIARRHOEA (diarrhea) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, THROAT TIGHTNESS (throat closed), DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
As soon as I started working at 05:00 am - I was trying to drink - water pouring out the the left side of my mouth. I went to the restroom - the left side of my face was drooping. I called Hospital right away and they told me to call an ambulance and get to the ER hospital - right away. CT scan within 30 minutes of me noticing the symptoms. I was in the hospital all day while they ran various tests. It lasted about 5 weeks - I was diagnosed with Bells Palsy. I don't remember if there was treatment at the ER that day. Sent home with me: Gabapentin for the pain that I was having with it. I took it as long as they wanted me to. They also gave me one course of Prednisone. Because I take Valtrex all the time, Valtrex is what I continue to take. They said it  might come back but it's probably not likely. I have had neurologic consults and NT consults and ophthalmology consult.
patient informed her that during the night he had 2 brief episodes of what he describes as "convulsions". Patient concerned of a possible reaction to the J&J vaccine he received yesterday during his office visit. Patient describes the episodes of convulsions as brief and that he had uncontrollable shaking only from his waist up. Patient also reporting that his breathing felt funny. Patient reporting that he did not lose LOC and was totally aware of what was happening. No loss of bowel or bladder. Mom reports that patient is difficult to get much more details from. Patient reports that he does have a slight headache presently, but otherwise had returned to baseline.
Fatigue, headache, nausea, ( a few hours after injection - 2 days after injection. Pain around injection site (a few hours - 1 1/2 weeks after injection). Red skin discoloration (noticed on 3/17)
Patient reported no adverse event. Vaccine was expired and administered to patient. After speaking with health department vaccine specialist, it was determined patient would need a duplicate vaccine in date.