chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine programt.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Information has been received from a physician concerning a patient who was vaccinated on an unspecified date with a 0.5 ml dose of Varivax. Subsequently the patient developed a breakthrough case of chickenpox. Unspecified medical attention was sought. The patient recovered. There was no product quality complaint involved. Additional information has been requested.
"Covid arm" - large warm rash around injection site, fever, chills, severe fatigue. Covid arm lasted four days. The remaining symptoms about two days.
Patient received a partial dose of the flu vaccine. Part of the vaccine dripped down on and patient did not get the full vaccine dose due a a leak where the needle connects to the syringe. Patient was thought it was unprofessional that the medication could leak. He stated he worked in the hospital field and that has never happened in his line of work.
Twitching; Muscle spasms  near the shot site every few minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 02Apr2021 at 15:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, anaemia, shellfish allergy, cockroach allergy and fruit allergy (allergy to tomatoes). Concomitant medications included sertraline hydrochloride (ZOLOFT), levothyroxine (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA) all for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00 the patient experienced twitching/muscle spasms near the shot site every few minutes. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event twitching and muscle spasms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Wasn't moving, crying a lot, not eating, swelling right leg, fever, throwing up dragging on (r) leg.
Gave Pediatric dose/formulation in error.  She is 12 yo so should have recieved the 30mcg dose.   No adverse event.  Per CDC recommendation a 5-11 yo dose given to a 12 yo it is NOT recommended to repeat the dose.
Headache, muscle & joint pain, general malaise - flu-like, nausea, diarrhea.
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Lot number: Fj4991) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DIVIGEL taken for hormone replacement therapy; PROGESTERONE taken for hormone replacement therapy. Past drug history included: Neosporin, reaction(s): "known allergy: Neosporin". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Poitive, notes: I tested positive; Negative, notes: I tested positive (after previously testing negative once the paxlovid was completed). Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported that patient received other medication in  two weeks. Anti-viral details are as follows: Patient was taking Paxlovid from 20Sep2022 to 25Sep2022 to treat covid-19. Covid rebound. On day 7 after completing the paxlovid, Patient became ill again with covid symptoms and tested positive (after previously testing negative once the paxlovid was completed.) Experienced congestion, mild cough, significant fatigue and malaise.
Moderna COVID-19 Vaccine EUA  7 days after receiving dose 1 of the vaccine, the injection site became red and warm. Initial reaction was about the size of a quarter, and continued to grow slowly over the next day. I marked the area of inflammation with a pen. and noticed the redness continues to spread down the arm, remaining warm, slightly itchy. No fever or other symptoms noticed.
Recieved my Pfizer booster shot.  Next day experienced fever of 100.8 at max . Fever continued for 2 days. Loss of appetite. Exhaustion. Experienced itching at injection site and then pain in injection site for 4 days after injection
MD reports pt recvd Hep B vax ID to a pt by mistake; nurse thought it was TB vax; pt is fine so far;
5-7? after vaccine, had a fainting episode- fell out of his chair, hit forehead on the floor. Vitals taken immediately after the event and again 10? after event. Vitals stable both times. Patient lay in a cot and drank water to recover. Felt well after 35? and left clinic.
A few hrs after injection (L) leg was noted to be red and warm to touch. Area of redness increased and pt was brought to office on 10/18/13 with erythema of 2.5 x 3.5 cm to (R) thigh and 12 x 5.5 cm erythema to (L) thigh there was minimal pain on palpitation.
LEFT ARM NUMBNESS; ARM SORENESS; LEFT SIDE OF THE BODY SORE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and other pre-existing medical conditions included the patient had history of no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left side of the body sore. On 06-APR-2021, the subject experienced left arm numbness. On 06-APR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness, left arm numbness, and left side of the body sore. This report was non-serious.
Injection site soreness started about 3 hours after administration Chest pain and headache started about 7 hours after administration, went away after 4-5 hours Severe nausea started about 14 hours after administration and lasted for 4 hours Body aches and chills started about 14 hours after administration, lasted for greater than 12 hours, on and off Took ibuprofen and tylenol alternatingly, started feeling relief of some symptoms about 20 hours after administration
Information has been received from a consumer concerning herself who on 28-NOV-2007 was vaccinated with her first dose GARDASIL (lot# not reported). Concomitant therapy included PRAVACHOL, ACIPHEX, BONIVA and KLONOPIN. On approximately 26-DEC-2007 the patient's face got red, swollen and had a little bit of dermatitis. The dermatitis cleared up after a couple days. On 03-FEB-2008 the patient experienced dizziness and tongue feeling thick. The patient reports the dizziness was better now better now, but at times when she leans over she gets dizzy. The patient's primary care physician ordered her to have a CT scan and an MRI in regards to the dizziness. The patient is recovering. Additional information has been requested.
For the first few days, I had massive  amounts of gas that were nearly non-stop. This morphed into gas with spurting rectal emissions consisting of mucus with shreds of excrements. Finally, for the last (I hope) phase, I had classic diarrhea. Really, the oddest case of diarrhea I?ve experienced.
headache; This is a spontaneous report from a contactable consumer (the patient herself). An 84-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 07Mar2021 (at the age of 84-year-old) at single dose for COVID-19 immunisation. Relevant medical history included diabetes and high blood pressure. Concomitant medications included metoprolol, isosorbide mononitrate and telmisartan. On 07Mar2021 the patient had terrible headache day all day into night. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash, mild swelling and tenderness on right deltoid where Dtap immunization was received. Happened 24 hrs after pt received shot. No Rx.
Initial reaction was fever, headache, fatigue, body aches which lasted for 2 days. Symptoms went away, and this was the pattern for previous 2 Moderna vaccines.  On 28 December, I developed hives on my face, hips, genital area, and shoulder blades/back. The hives itched incredibly. I started taking Cetirizine prescribed by the doctor. The hives receded, but I must take Cetirizine every 24-48 hours or I have a persistent urticaria. Very itchy skin, raised welts on abrasive contact. Itching usually started on the palm of hands, eyes, and/or lip and mouth area. That is the sign I used to take another pill. I have since been diagnosed with urticaria officially by a dermatologist and prescribed cetirizine daily for 90 days, with a break afterward to see if symptoms cease.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Chronic pulmonary lung blockage" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "I could not walk" (unspecified if ongoing), notes: I could not walk enough to do my job or breath. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "sore"; GOITRE (non-serious) with onset Sep2021, outcome "not recovered", described as "Right, Thyroid gland and under the left arm swelled"; PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "left arm swelled". Therapeutic measures were not taken as a result of myalgia, goiter, peripheral swelling. Additional information: No prior vaccination with in 4 week. Reporter stated, he was not taking any pain medication like tylenol or anything. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT had Covid Pfizer vaccine on 02/01/21 at 8:47 am with no adverse reactions. While working at her desk at 11:40 am, (employee) patient states had gradual bilateral arms and bilateral legs shaking and back went into spasms. No loss of consciousness. PT walked to vaccination pod where seen by MD Resident and then take to ED for further exam
Incessant tinnitus in both ears which is more prevalent in a quiet room and when trying to sleep; occasional, intermittent ear ringing separately in each ear (for 5 to 10 seconds) but has been more infrequent than the incessant tinnitus; feel slightly off balance / unsteady; sensation of wanting to "open" Eustachian tubes by yawning; ear fullness / clogged, as if there is liquid in them blocking sound; occasional popping/cracking in ears; occasional itch of inside the ear; slight pressure in the head; a feeling of being mentally "slower" or "brain fog"; an occasional pulse in ear (not with my heart's pulse) which is akin to hearing a drum beat a few times inside your head; incessant tinnitus sounds is like you've left a TV on but it is on no channel or has no cable input; symptoms have created much anxiety.
Patient is 56-year-old male who presents to the ED for complaint of febrile reaction and swollen axillary lymph nodes after covid-19 vaccine.   Patient reports febrile episode overnight.  Patient reports fever up to 104, chills, and diaphoresis.  Patient reports nausea without vomiting.  Patient reports axillary lymphadenopathy, however no chest pain, shortness of breath, sore throat, syncope, palpitations, or diarrhea.  Patient has history of CLL, which is currently just being monitored without treatment.  Patient otherwise feels well, is a nonsmoker, has no significant confounding illnesses.Patient was hospitalized for viral pneumonitis subsequent to covvid-19.
This spontaneous report was received from a registered nurse and refers to a 11 month old male patie. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 09-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 29 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hours after giving the shot. Patient was given benadryl and felt better in about 1 hour, he went home and the next day came back to work normal
Father of child noticed a bump under the skin in patient's right upper thigh last night when changing his clothing.
Child here for H1N1 vaccine. .5 ml given IM by mistake. Call to mother. Felt tired yesterday but better today 10/28/09.
Inability to experience an erection; Inability to sleep; A spontaneous report was received from a male patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inability to sleep/ insomnia and inability to experience an erection/ erectile dysfunction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 037A21A) through intramuscular route (deltoid) in left non-dominant arm for prophylaxis of COVID-19 infection.  On 17 Mar 2021, after receiving the first dose, patient had an inability to sleep or experience an erection. The event inability to experience an erection was considered as medically significant. The patient did not receive any treatments for the events.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events, inability to sleep and inability to experience an erection was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Approx 3" X 2" red and swollen L upper arm. Warm moist soaks, Advil or motrin every 6 hours X 2 days
Got shot on 8/25 and 3 days later got red/inflamed ring around injection site and itchiness. Recommended ice and acetaminophen, 2hrs later pt reports improvement.
Episodic left arm pit pain; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 07Apr2021 at 17:15 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included lung lobectomy in 2008 to address pulmonary sequestration. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 17Mar2021 at 17:15 (at the age of 53-year-old), as a single dose for COVID-19 immunisation and took Clarithromycin, Amoxicillin and Clindamycin; all on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. On 09Apr2021 at 02:00, the patient experienced episodic left arm pit pain. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event episodic left arm pit pain was recovering.  No follow-up attempts are needed. No further information is expected.
Weight loss; Fever of 103; Chills; Skin rash; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 22Jul2021 at 12:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergy to sulfa medication. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021, the patient had weight loss, fever of 103 (units unspecified), chills, skin rash and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weight loss, fever of 103, chills, skin rash and fatigue were recovered on an unknown date in 2021.
Patient received expired ACT-HIB vaccine/ NO AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (reference number- 00730100).  This case involves a 1-years-old female patient who administered expired vaccine (expired product administered) HIB (PRP/T) VACCINE [ACT-HIB].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 19-Jul-2021, the patient received a 0.5 ml first dose of suspect HIB (PRP/T) vaccine (frequency: once, strength: standard, lot number: UJ183AA and expiry date: 12-Feb-2021) via an intramuscular route in the right thigh for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  It was reported as "patient received an expired ACTHIB vaccine; asking if patient will need to be revaccinated. Event Information -Treatment: patient did not receive treatment for this event ".  At the time of reporting, no adverse event reported.  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.
Metallic chalky bad taste in mouth that has continued to present day (7 months); This is a spontaneous report from a contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an intramuscular route of administration in the right arm on 27Apr2021 at 08:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an intramuscular route of administration in left arm on 06Apr2021 at 08:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 11:00, the patient experienced metallic chalky bad taste in mouth that had continued to present day (7 months). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic chalky bad taste in mouth that had continued to present day (7 months) was not resolved at the time of this report.
muscle aches, light headed, fainted, nausea, head ache, and diarrhea
This spontaneous report as received from a nurse refers to a 66 year old patient of unknown gender. On 11-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # H020000, subcutaneous. On 11-FEB-2013, 1,5 hours after onset of therapy the patient experienced severe back pain. He was evaluated at a local emergency room but a diagnosis was not available. The outcome of severe back pain was not provided. This case was cross referenced with case 1303USA001456. Additional information has been requested.
High fever for 24 hours. After than I came down with really nasty and massive number of cold sores (at least 20 of cold sores) all around my mouth, nose, inside two nostrils. Tip of my nose and nostrils are deformed because of size of cold sores inside my nose. It has been 12 days that I have this condition and sores are being persistent and there is no sign of getting better. I took several pictures of the affected area to document the case.
Local adverse reaction - thigh cellulitis extends 5 x 7 cm in diameter.