chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Engerix-B pediatric dose instead of an adult dose; received Engerix-B pediatric dose instead of an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was looking for medical information because the reporter realized the someone received Engerix-B pediatric dose instead of an adult dose, which led to underdose and adult use of a child product. At the moment of the call there were any details about patient involved but was going to search them.  The reporter also did not know if this error was for a first or second dose in patient´s vaccine schedule. The reporter consented to follow up by email.
Headache, Arthralgia, Fatigue, injection site pain and swelling Narrative:
Extreme Fatigue, Elevated Temperature,  Lethargy, Lost Appetite, Muscle Pain, Sore Arm of injection site,  Exhaustion
woke from nap w/sore legs, t102-103; vomited late PM & eve, irritable didn't sleep well that noc; called MD gave APAp; no temp or vomiting next day;
Fever; vomiting; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 26Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on an unknown date in 2021 at 12:00 as a single dose for COVID-19 immunisation. On 27Apr2021 at 02:00, the patient experienced fever, vomiting, diarrhea and chills. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, vomiting, diarrhea and chills were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Brief syncopal episode the morning after receiving Flumist intranasal vaccine without injury or lasting effects.
Vaccine affected my ability to fall asleep even with medication.  If I fall asleep and have to get up for rest room I am unable to fall back asleep as I was always able to before.  It affected the medication making it necessary to take more  and more to work and sometimes it doesn't work.  My sleep has been destroyed by vaccine.  It's been almost 4 months and no improvement to my sleep.
Headache, dizziness, fever, congestion, and fatigue lasting four to five days.
Was menstruating at time of second shot, but near end of bleeding stage  Within 4 hours of second shot: pain in vaccine arm (right arm), veins at wrist of vaccine arm (right arm) also began hurting/throbbing; off and on pins and needles feeling in thighs; began feeling strange -- just feeling that things were happening inside my body; headache when playing with child  Within 16 hours of second shot: feeling of malaise, sadness, lethargy, lack of appetite, extreme thirst. Redness at vaccination entry site (had this after first shot as well)  Within 20 hours of second shot:  feeling of malaise, sadness/crying, lethargy, really tired, lack of appetite, extreme thirst, very very cold extremities (especially fingers), chills, body aches, weakness, nausea, low grade fever, pain in vaccine arm, several hours of alternating shaking chills and sweats  Fever broke and chills, sweats, nausea subsided by 26 hour mark since second shot. Lack of appetite, weakness, tiredness continued.  40 hours post second shot: all major symptoms subsided, except feeling of apathy, lack of energy  By 48 hours post second shot feeling mostly better.  5 days post second shot: STILL BLEEDING FROM PERIOD!!! Unheard of. Never had something like this happen. Also had blinding, excruciating, utterly debilitating pain in vaccine arm upon waking from overnight sleep. The most horrible pain; was sobbing with the pain.  Could not lift arm, intense muscle pain in upper arm on vaccine arm (right arm). Mostly subsided after about an hour of massaging, but still have dull pain and do not have full range of motion 2+ hours later.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included antidepressants.; 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
joint pain; This is a spontaneous report from a Pfizer sponsored program. A contactable Female consumer reported for herself that a female patient with unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/ batch number; not provided) via an unspecified route of administration on 18Jan2021 at 1st dose, single for covid-19 immunization. Patient's medical history and concomitant medications were not reported. The patient received her 1st dose of Covid vaccine on 18Jan2021 and was told to call Pfizer as she was experiencing joint pain on an unspecified date. She called to see if joint pain was a side affect. She received a letter asking her to fill out a form about the joint pain. She is wondering if she needs to fill out form or not.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Total Body aches and pains for 3 days Migraine for 3 days Fever for 2 days Herpes developed 48 hrs later..I had herpes inside my nose .I had 4 areas on my lips and also had herpes all over the inside of my mouth all around my gums top and bottom
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-JUN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK- 0.5ml SD-PFA LLok wTip" (lot # M005286, expiration date 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Pt vaccinated with DTP/OPV developed rash, allergic event consisting of wheezing/asthma following immunization.
No adverse event Pt received expired dose. Expiration Date: 10/13/2021 Date of Administration: 10/14/2021
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No Concomitant medicines were reported.   This case was linked to (Patient Link).
Fatigue; headache; swelling or a lump in clavicle; chills; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Apr2021 14:45 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 27Apr2021 (Lot number: Unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to aspirin" (unspecified if ongoing); "Allergy to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Allergy to naproxen, reaction(s): "naproxen - Allergy", notes: Verbatim: Allergy to naproxen.  The following information was reported: FATIGUE (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "headache"; BONE SWELLING (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "swelling or a lump in clavicle"; CHILLS (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "chills"; DIARRHOEA (non-serious) with onset 19May2021 02:00, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, headache, bone swelling, chills, diarrhoea.  Additional information: Patient was not received any vaccine in four weeks nor any medication in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination and was tested for covid-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to pharmacy on 10/5, 2 days after the immunizations were given complaining of swelling and redness at the site. Stated his friend said he had a cut. I, the pharmacist, inspected the arm and there was no cut, but it was red and swollen. The patient had spoken to the doctor to take ibuprofen and use an ice pack. The patient asked if he could work out, but I advised against it. The following morning, the patient came back to the pharmacy complaining of pain starting from the injection site down the arm towards his hands. Site was still swollen and red.
She fell and had an accident; She fell and had an accident; The hospital was going to send her home, but her A-Fib went off suddenly; she couldn't breathe; they treated her lungs for inflammation; to see if she had pneumonia. She was put on antibiotics; Anxiety; fatigue / She is very fatigued; She has memory issues since hospitalization; She is now stuttering; This is a spontaneous report from a contactable consumer (daughter) An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation and started to receive palbociclib (IBRANCE) via an unspecified route of administration on an unspecified date to an unspecified date at 100mg, unspecified frequency and via an unspecified route of administration on an unspecified date to an unspecified date at 75mg, unspecified frequency, for an unspecified indication. Medical history included atrial fibrillation (A-Fib) from an unspecified date and unspecified if ongoing. Concomitant medications were not reported. On unspecified dates the patient experienced she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering. The clinical course was reported as follows: "My mother has anxiety and fatigue as her main symptoms. She did go into the hospital recently. She fell and had an accident. My mother got the vaccine a day before the event happened, so not sure if that contributed to the accident. The hospital was going to send her home, but her atrial fibrillation (A-Fib) went off suddenly and she could not breathe. They almost sent her to the intensive care unit (ICU). They got her and her heart rate stabilized. She had difficulty breathing, so they treated her lungs for inflammation. They did a computerized axial tomography (cat) scan of her lungs to see if she had pneumonia. She was put on antibiotics. She went down on the dose of palbociclib from 100mg to 75mg. She was very fatigued. She had adverse events to the antibiotics. She became psychotic on them. She had memory issues since hospitalization. She was now stuttering."  The action taken in response to the events for palbociblib was dose reduced. The clinical outcomes of the events she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
low grade fever to 99.6F for 24 hours relieved by taking one Advil 200-mg on 1/1/2020 11:00 a.m..  Very painful injection site for 3 days relieved with warm compressives.
About 3 hours after receiving the first dose of the Pfizer covid-19 vaccine, I began feeling a pain on the left side of my chest, near my heart. It lasted for about an hour. I treated it by taking amlodipine which usually helps me with angina pain.   The same pain occurred two other times within a week of the first dose.
Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
L thigh 3cm x 5cm red warm lesion no blisters no pechiae skin site at injection clear and dry no discharge.
HPI: Patient is a 35 year old male who presents following administration of a single dose of J&J COVID19 vaccine in the left deltoid.  Patient started to feel light headed and nauseous while walking to his car.  About 20 minutes following vaccination, a vaccinator had walked passed his vehicle and noted that he was unconscious.  Patient was still unconscious upon medical response team arrival and unresponsive to stimuli.  Once the patient awoke about 30 seconds later, he continued to state that he was nauseated and ?did not feel good.?  Patient was unaware that he had lost consciousness.  He further disclosed that he had been working in the sun planting trees all day and had not consumed any food or beverage.  He denied allergies to medication, food, and other vaccines.  He relayed that he had passed out from vaccinations in the past as a child.  He affirms lightheadedness and nausea.  He denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, and vomiting.     Exam (update as needed): GEN: Upon arrival, patient unconscious and not responsive to stimuli HEAD: NCAT EYES: pupils unreactive and mydriatic ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g, palpable strong radial pulse PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN:  Skin pale, cool, and clammy.  No rashes.  No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Patient unconscious upon arrival.  CN 2-12 grossly intact, no ataxia, gait steady   Clinical Impression/Field Tx: Vasovagal syncope.  EMS called immediately to respond to the site for further evaluation.  Patient placed into a reclined position.  Patient not displaying active signs or symptoms of anaphylaxis.  Upon regaining consciousness, patient was alert and oriented x4.  Once the patient demonstrated ability to control airway, he was given candy and water.  EMS arrived and an EKG and BGL were performed, both of which were normal.  Vital signs were stable.   Instructed patient to consult their PCP regarding the post-vaccination reaction.  Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention.     Medications administered: None   Disposition:  FD EMS called to the scene for further evaluation.  Patient elected to go home after evaluation by EMS.
Less than 24 hours after vaccine administration of 10/7/03, client describes severe headache "like no other before". Pulse 68, B/P 144/94, Temp 97.7, c/o photosensitivity. Referred to Emergency Room, CT head negative,tx with pain medications, scheduled for MRI 10/10/03
After receiving flu vaccine pt walked over to recovery after pt stated he didn't feel very well - placed head between knees. B/P - 127/70, P - 70. Pt then laid flat for a few minutes without drinking anything. Placed  in W/C and brought to clinic for MD check when he felt well and was dismissed. He noted everyone in his family gets sick with shots.
severe eye pain and redness in right eye. per eye doctor, diagnosed as Episcleritis or Uveitis
myalgia; Trouble breathing; Couldn't pull myself out the bed and didn't get out the bed; Confusion; Chills; Joint pain; Headache; Fatigue, but nothing serious; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue, but nothing serious) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Bypass surgery (5 Bypass surgeries). Concurrent medical conditions included Arthritis, Diabetes and Heart disease, unspecified.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue, but nothing serious). On 17-Apr-2021, the patient experienced MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), CONFUSIONAL STATE (Confusion), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 17-Apr-2021, CONFUSIONAL STATE (Confusion) had resolved. On 19-Apr-2021, MYALGIA (myalgia), DYSPNOEA (Trouble breathing), ASTHENIA (Couldn't pull myself out the bed and didn't get out the bed), FATIGUE (Fatigue, but nothing serious), CHILLS (Chills), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No Concomitant product use was reported. Treatment medication for the event included Percocet.   This case was linked to MOD-2021-163938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR added on 25 May 2021 and updated patient second dose information
Patient was hospitalized for covid pneumonia (positive for covid infection); This is a spontaneous report from a contactable physician. A 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at single dose for COVID-19 immunization. Medical history included patient's wife had contracted covid infection the week prior the patient received his first dose, in Jan2021, and patient did not have symptoms of covid infection at time of 1st dose vaccine. Concomitant medications were not reported. Patient experienced covid pneumonia in Feb2021 (positive for covid infection in Feb2021) and was hospitalized on 08Feb2021. Patient received treatments as follows: 12L O2, steroid, remdesivir and convalescent plasma. Patient was fully recovered from the event in Feb2021.   Information on the lot/batch number has been requested.; Sender's Comments: Covid 19 pneumonia is assess as an intercurrent medical condition based on patients exposure to a patient who is positive for Covid 19 prior to vaccination.   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
Rash on arms, legs, backside. Looks and feels like the start of poison ivy but the bumps are smaller and not quite as itchy. While the rashes are large, I'd call them minor as they aren't terribly disruptive. I marked item 20 as not recovered because it just showed up yesterday. I don't know how long to expect the rash to remain. This does not seem to need medical attention.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: P23197) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Antiviral details: Product: COVID 19 Treatment Brand: Paxlovid , Start date: 27May2022, Indication: Treatment of COVID-19  Follow-up attempts completed. No further information expected.