chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Metal taste within minutes of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old not pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: Unknown), via an unspecified route of administration in left arm on 26Mar2021 at 14:30 (at age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. The patient had not been tested for Covid-19 since the vaccination. On 26Mar2021 at 14:30, the patient had metal taste within minutes of the vaccine. The patient did not receive any therapeutic measure for the reported event. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event metal taste within minutes of the vaccine was resolving at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Loss of appetite and severe fatigue began the days after vaccination. Excessive vomiting began two days after vaccination and continued for 7 days. Pt was hospitalized from 7/22 - 7/26 and treated for dehydration while they ran tests that came back inconclusive. Two weeks later, pt experienced a seizure and was rushed to the ER. She was hospitalized from August 8 - August 17th where she was found to have bilateral subdural hematomas and retinal hemorrhaging.
8/15/2023 - 8/31/2023 (16 days) Date of Admission: 8/15/2023  Discharge Date:  08/31/2023 Discharge Disposition: Skilled Nursing Facility (SNF) with Certification in Anticipation of Skilled Care  past medical history of chronic anemia, coronary artery disease, dementia, gastroparesis, osteoarthritis, hypothyroidism, hypertension, hyperlipidemia, ALF resident, who presented with increasing altered mental status over the past several weeks prior to arrival.   Patient currently breathing well on ambient air.  Discontinue dexamethasone.  Discontinue remdesivir.  Status post 6 days of Rocephin.  5/24/2021 Janssen 205A21A
day p/shot pt reported general sense of malaise, swollen arm @ inj site w/multiple pin head sized dark red purple bumps (rash)-some bleeding @ site & red raised welts radiating from site in 3-4in diameter-resolved x 1wk
On 2/23 pt developed fever 105.8F (ear) was evaluated at  hospital for febrile seizures
gave a patient a double dose of MENQUADFI vaccine by accident with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who experienced gave a patient a double dose of menquadfi vaccine by accident with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2022, the patient received a  dose of suspect meningococcal a-c-y-w135 (t conj) vaccine two doses lot U7373AB of ex[iry date 06-Aug-2024 via intramuscular route in the left deltoid for Immunization..  On 24-Oct-2022 the patient developed a non-serious gave a patient a double dose of menquadfi vaccine by accident with no reported adverse event (extra dose administered) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  It was reported "Caller is reporting that they gave a patient a double dose of the MENQUADFI vaccine by accident and they are asking if there are any potential symptoms or adverse reactions they need to be on the lookout for, 16 year old patient was administered two doses of MenQuadfi. She asks for appropriate follow-up. She asks what are the potential adverse reactions".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Five minutes after vaccine administration child began to gag, itch and lips looked blue, sob, and severe itching of scalp and skin. Gave Epipen Jr.,orapred 30 mg. Benadryl 12.5mg and monitored x 2 hrs. Rash and hives, no respiratory or mucus membranes symptoms.Follow up by phone in am. and notified allergy specialist.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-MAR-2007, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 19-AUG-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Within 30 min. of dose, pt, said she felt like head "swimming" and gut nauseous. By 6PM, pt had vomited 6 times. About 7PM, she developed body aches overnight, she developed fever (reached 102.5) and had aches, chills and sweats.
This spontaneous report was received from a Licensed Practical Nurse refers to a 11 month old female patient. On 09-NOV-2000, the patient was vaccinated with dose 1 of VARIVAX (merck) (lot#, expiry not reported) which was 5 days before the patient's first birthday. Nurse mentioned the patient received her second dose of VARIVAX (merck) (lot#, expiry not reported) on 10-SEP-2010. No adverse symptoms reported. Additional information has been requested.
More than a week after injection 4" vertical by 3"  horizontal red, swollen, tender area appeared has persisted for four days so far.
Pt. presented with rash on back, face, and behind ears. Mom stated that new lesions keep appearing. Pt. positive for itching, negative for temp., negative for n/v/d.  Mom states rash began on 7/17/2007.
HEADACHE; 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 rheumatoid arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, therapy start date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Felt sick when I left the pharmacy. Taste in my mouth. Legs felt shaky. Went home shortly after started to vomit until I had dry heaves. Headache, bad chills, and couldn't get warm. Shaking fever went to 103.5 degrees. So sick all night but didn't call for help as my husband kept track of me. I called the drug store next day and my doctor.
An unspecified patient who was administered a dose of Gardasil 9 on an unspecified date had pre-existing warts in an unspecified location that resolved on an unspecified date following administration of gardasil 9.; This spontaneous report was received from a physician referring  to a male patient of unknown age.  Patient's concurrent conditions, medical history, concomitant medications, drug allergies or reactions were not reported.     On an unspecified date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, administration route, dose number, lot number and expiration date was nor provided) for prophylaxis.       On an unspecified date (reported as following administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) ),  the patient recovered from a pre-existing warts on an unspecified location.  The event outcome was unknown.  And the reported did not assessed the causal relatedness between the event and vaccination with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) .   This is one of several reports from the same reported .; Sender's Comments:  US-009507513-1906USA001693:
No symptoms for first 24 hrs, then I started noticing what I thought were bug bites on all 4 of my extremities.  After taking benadryl and scratching myself raw, I went to the Dr.s 72 hours post shot. This was my first Pfizer booster.  All 3 previous shots were Moderna.  I was diagnosed with hives and treated with a course of prednisone, which resolved the hives within 48 hrs.
Injection site erythema; Itching; Injection site pain/ tenderness, pain to touch at injection site; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 2nd August 2019 and experienced fatigue, refer case US2019187932).   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and nausea. On 16th October 2019, the patient experienced injection site erythema and injection site itching. Rechallenge with Shingrix was positive. On 16th October 2019, the outcome of the injection site pain, fatigue and nausea were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. On the same day, after receiving Shingrix, the patient experienced injection site pain with nausea and fatigue.  The nausea and fatigue resolved in 48 hours. On the date of reporting, the patient noticed redness about 1 inch from the injection site with diameter of about 3-4 inches which included tenderness, pain to touch and itching. The reporter consented to follow up.
PT. REC. VARICELLA VACCINE LT.ARM LATERAL ASPECT SUBCUT ON 3/24/08- MOM CALLED AND STATED THAT PT'S ARM HAD REDNESS AND SLIGHT SWELLING. ASKED PARENT TO BRING PT IN. MEASURED REDNESS 3CM X 4CM HAD SLIGHT SWELLING. NO PAIN OR ITCHING. I TALKED WITH N.P- WHO ADVISED ME TO TELL PARENT TO GIVE TYLENOL FOR PAIN AND BENADRYL FOR ITCHING IF NEEDED AND TO COME BACK IN IF SHE WASN'T ANY BETTER.
nose bleed; This is a spontaneous report from a non-contactable nurse(patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot n umber and expiration date was not reported), via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. The patient experienced nose bleed on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Flushing, hives, tachycardia, diaphoresis to 140s within 3 minutes of vaccine. At vaccination site, blood pressure 104/60, slightly lower than normal blood pressure. At vaccination site, patient was given 25 mg Benadryl IM. HR started going down about 15 minutes after Benadryl. HR went down to 90s upon arrival to the ED. HR is normally in the 60s. No further treatment in the ED.  Patient did experience fever  up to 101 and malaise for 3 days after vaccine. Along with pain at injection site.
TRIGGERED FIBROMYALGIA; HAVE BEEN SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-APR-2021, the subject experienced have been sick. On an unspecified date, the subject experienced triggered fibromyalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the triggered fibromyalgia and have been sick was not reported. This report was non-serious.
No symptoms or issues with my first Pfizer vaccine. 15 minutes after the 2nd dose of my Pfizer vaccine I experienced a metallic taste in my mouth.  That lasted for a few hours after the shot. A rash began above my right hip on my abdomen around 3-4 hours after the injection in my upper left arm. It was a small patch of itchy red hives. The rash now is spread from hip to hip and is continuing to grow. It?s on fire like itch and flares up and then calms down a bit on its own. At about 11 hours after the vaccine I came down with a high temp fever at 102.8 that lasted for 14 hours. Tylenol and Advil did little affect. I had body chills, cold sweats, a terrifying headache, severe vomiting multiple times that I?ve pulled my rib muscles or collarbone area and is now painful to breath in. I dry heaved multiple times for over 3 minutes at a time. My joints were sore and I had muscle pain, insomnia but fatigue at the same time. After 14 hours the fever broke along with the chills, joint and muscle pains. My headache remained as well as my abdominal rash, my fatigue and my cold sweats well into the 3rd day. It?s now day 4 and almost all symptoms have resided except my rash, which continues to grow and itch worse, and my headache.
Hip Joint pain, Shoulder Joint Pain (opposite from injection site). Knee Joint Pain, numbness in fingers, slight fever. Starting at 3:30 am pain in joints prevented sleep, joint condition made walking difficult. Second day pain in joints diminished, finger numbness remains malady remains.
Shot was administered on tip of shoulder near previous site of arthroscopic surgery. Acute pain followed. Required sleeping with braces supporting. Pain has continued for 2 weeks following. Limited movement in shoulder and Weakness when lifting light objects. In certain positions shoulder crackles, pops, and rips audibly. This was not occurring prior to injection.
Sneezing; Congestion; Fatigue; Achy body; Tiredness; This is a spontaneous report from a non-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: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 08:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no allergies to medications, food or other products. Concomitant mediation included fluoxetine hydrochloride (PROZAC) for an unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Mar2021 at 16:00, the patient experienced sneezing, congestion, fatigue, tiredness and achy body which continued for 5 days after vaccination with no fever, no loss of taste or smell. The patient did not receive any treatment for the events of sneezing, nasal congestion, fatigue, tiredness and achy body. The clinical outcome of the events sneezing, nasal congestion, fatigue, tiredness and achy body were resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
the second injection was later than what the PI for GARDASIL 9 recommens; This spontaneous report was received from the consumer and refers to a 27-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.   On unspecified date in January 2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 02-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis and now he wanted to get the third injection. The second injection was later than what the prescribing information (PI) for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) recommended.
Muscle soreness & pain 6 months after I received vaccine.  Have had for about 2 weeks.
Mom called at 10:00 AM stated patient's right arm at injection site red and hard.  No other symptoms noted, redness occurred that night.  No treatment needed.
The patient also received a dose of Polio vaccine, manufacturer and lot # unknown, during the same visit. The patient did not experience any adverse reactions after Td administration. The responsible physician (source) reported that the medication error was due to label confusion. The healthcare facility had undergone some recent changes to their vaccine storage locations. At the time of vial verification for this case, the attending healthcare professional indicated that it was difficult to identify the name of the vaccine on the vial which resulted in Td being inadvertently selected and verified instead of DTaP.  The source went on to explain that the healthcare professionals normally use the vaccine abbreviations (e.g., Td, DTaP) and not the full product name on the vial, thereby adding confusion.; Sender's Comments: This medication error was assessed as non-serious. The Td vaccine was administered to a patient that was under the prescribed age for the vaccine.
This spontaneous report as received from a health professional refers to an unspecified number of patients. On unknown dates the patients were vaccinated with doses of improperly stored doses of VAQTA (lot #, expiration date, dose and route unspecified). No adverse events were reported. No additional information was available at that time. This is one of several reports received from same source. Additional information has been requested.
2/17/21 Pt w/fever, SOB and diarrhea. Positive household exposure to COVID.  + for SARS-CoV-2. Was given fluids and no hypoxemia. Discharged to home and set up with monoclonal AB infusion 2/18/21 In am pt received bamlanivumab w/o issue 2/18/21 several hours later pt returned to ED w/fever to 103.1, tachypnea and hypoxemia. Pt was started on steroid and he had rapid improvement. He weaned off oxygen on 2/19.  He was discharged 2/20.
Hives on my neck; This is a spontaneous report from a contactable consumer (the patient). A 31-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201), via an unspecified route of administration in left arm on 11Mar2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunization. Medical history included asthma. Patient was allergic to Augmentin. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]).The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. On 12Mar2021 at 05:00, the patient experienced hives on neck. The patient did not receive any treatment for the adverse event. The event was assessed as non-serious. The outcome of event was recovering.   Information on the expiration date has been requested.   Follow-up attempts completed. No further information expected.
Headache, fever, chills, night sweats, lethargy, sore throat, minor chest discomfort, racing heartbeat.
pt stated that after 9 days she developed a red rash on her left arm around the injection site.  She states it is not itchy or painful.  She saw a dermatologist on 3/9/2021 for an already scheduled appt. and he told her it was a normal reaction and was not too concerned about it no medicine was prescribed.
4FEB97 fussy, dec oral intake, fever, nasal congestion;impression: UTI.  Plan: ceftriaxone & Bactrim 3/4 teas 12hr x 1wk;6FEB97 lethargy, irritability;hosp hemolytic anemia;7FEB97 acute renal failure, disseminated intravascular coagulation
a few minutes after administering the first dose of the vaccine pfizer into her left arm,  the patient became very pale and couldn't hear what we were saying to her and partially lost her consciousness but then came back. when the ambulance came over, they took her out on a stretcher .
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, for prophylaxis (dosage information, lot number and expiration date were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766.