chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurses gave an expired Tenivac Vaccine with no adverse event; Initial information was received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient with unknown demographics and nurse gave an expired Diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, a nurse gave an expired total dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult suspension for injection 0.5 ml (expiration date: Oct-2018) (with unknown strength, lot number and administration site) via intramuscular route for immunization with no adverse event (expired product administered) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red rash on upper arm, hot to the touch, hard, swelling.  Started eight days after and is still happening fifteen days after
PFIZER: Dose: 01 on 04Nov2021; Dose: 02 on 26Nov2021; Off Label Use; Booster; interchange of vaccine products; staphylococcus Aureus; Bumps around injection area, and face that itch; face that itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 (Lot number: FF2593) at the age of 29 years as dose 3 (booster), single and administered in arm right, administration date 26Nov2021 (Lot number: FH8027) as dose 4, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Past drug event:, drug name: No, reaction: allergy. The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number:01, Manufacturer: Moderna, Batch/Lot#: unknown, Route: unknown MD, Anatomical site of injection: Left& Right arm, No. of previous doses : 2), administration date: 05May2019, when the patient was 27 years old, for Immunization; Janssen covid-19 vaccine (Dose 2, Manufacturer: Janssen, Batch/Lot#: 043A21A, Anatomical site of injection: Left arm, No. of previous doses : 1), administration date: 15Jul2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: STAPHYLOCOCCAL INFECTION (medically significant) with onset 2021, outcome "unknown", described as "staphylococcus Aureus"; IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 04Nov2021, outcome "unknown", described as "Off Label Use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Nov2021, outcome "unknown", described as "interchange of vaccine products"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Bumps around injection area, and face that itch"; PRURITUS (non-serious) with onset 2021, outcome "recovered with sequelae", described as "face that itch"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 26Nov2021, outcome "unknown", described as "PFIZER: Dose: 01 on 04Nov2021; Dose: 02 on 26Nov2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of staphylococcal infection. Therapeutic measures were not taken as a result of vaccination site swelling, pruritus.  Clinical Information: No hospitalization Prolonged Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Spoke with primary care doctor specifically about COVID and staphylococcus Aurous, on my annual visit I told her my symptoms and I was prescribed Amoxicillin -Pot clavulanate 825/125 mg tab. Also Ventolin HFA  108 MCG/ACT aerosol solution. Also recommendation for medical marijuana when affordable.  Follow-up attempts are completed. No further information is expected.
Low heart rate down to 33-35 from January 16-27 while sleeping then resolved.
Basic Symptoms; Ache; Sore arm; Didn't feel good for a week; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Basic Symptoms), PAIN (Ache), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Didn't feel good for a week) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION COMPLICATION (Basic Symptoms), PAIN (Ache), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Didn't feel good for a week), CHILLS (Chills) and NAUSEA (Nausea). On 24-Mar-2021, VACCINATION COMPLICATION (Didn't feel good for a week) had resolved. At the time of the report, VACCINATION COMPLICATION (Basic Symptoms), PAIN (Ache), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported. No Treatment medications reported.  Reporter reported that patient experienced the "basic symptoms" and a sore arm after the vaccination. Patient confirmed what her husband (reporter) had reported and added aches, chills and nausea that began the day after receiving the second dose. She states she didn't feel good for a week.   This case was linked to MOD-2021-381515 (Patient Link).
Post vaccination, upper arm became "hot" at injection site. A bruise 5" x 7" developed.
pt recvd vax;sl fever;woke up at midnite crying in pain'could be comforted while being held very still;screamed out w/ even sl movement;2am t 104.2 R;apap given;to sleep,found to be awake but not moving;t 104,apap given;t returned to nl;
On 12/6/2021, at approximately 3pm (4 hours post-treatment): Elevated blood pressure (170/108) and heart palpitations, headache, soreness/pain at injection site and in armpit (lymph node swelling), and at approximately 5pm headache, fatigue, nausea, chills, and fever onset. Fully recovered by morning of 12/8/2021.
Patient developed hives several hours after injection, there was no anaphylaxis, hives have been recurrent.
After about 6 minutes post-injection, she started feeling really dizzy and briefly passed out.  After a couple minutes she was responsive, but still really weak and tired and said she had blurry vision.  We called 911 and they came in and monitored blood pressure and heart rate, which was really low when they started, but did come back up into normal range and patient was feeling much better after about 15 minutes, but still tired.
Mom states that since vaccinations received, child stares into space and does not respond to her name at times. States occurred on the way home after vaccine and has not occurred since yesterday.
Muscle ache (whole body), muscle weakness (whole body), headache, and injection site pain started about 4 hours after injection and lasted for about 36 hours.  Chills with shivering was very intense for about 10 minutes about 10 hours after vaccination, then chills and hot flashes/sweating happened alternately for about the following 24 hours.  No treatments.
Unprovoked first-time seizure. Teen was sitting outside a restaurant waiting while watching phone, listening to music 15 days after first Pfizer COVID vaccine (no issues at time of vaccination). Parents witnessed his neck and eyes roll up and left before having a two short generalized tonic-clonic seizures.  Taken to nearest ED by paramedics.
Fever; fatigue; Headache; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M10A and 030L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included VITAMIN and LISINOPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 02-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches).   The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 101 f (High) Patient had fever of 101 F.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Shingles. Treatment: Acyclovir, lidocaine gel and gabapentin
A report recently sent from the regulatory authority in 2022 identified an error with patient's DOB and vaccine administered in 2021.  On investigation, it was identified that the patient received the Pfizer COVID-19 authorized for children 12 years and older (ie, 30 mcg) while the patient was 11 years old.  The patient's consent was completed with a birth date of 6/29/2008, but her actual birth year is 6/29/2009.  A second dose was administered on 6/5/2021 of the same lot number.  No adverse events/outcomes were reported.
generalized sz, multiple; blood tests nl; head CT shows atrophy, EEG is nl; pt has congenital nevus sebaceous; skeletal survey neg; treated w/Phenobarbital;
Patient requested Moderna Bivalent Booster vaccine received from the pharmacy a medicine container with Moderna vaccine vial and the handwritten label read: Moderna Bivalent, Lot 063B22A, with expiration date 03/02/2023, out of freezer 0950 am, 2/22/2023. Inside the medication container was a Moderna Monovalent vaccine vial. RN administered 0.50ml Moderna monovalent covid-19 vaccine instead of the recommended bivalent Moderna vaccine. As soon as RN noticed the error, patient was immediately notified that he received Moderna COVID-19 monovalent booster instead of COVID-19 bivalent booster, patient was monitored for 15 minutes, no adverse reaction was noted advised patient to report any delayed reaction to RN, pt verbalized understanding.
Sleep walking with night terrors. When he is awake he thinks the dream is still real. He believes ?they? are trying to kill him. He is terrified. He can?t go to sleep without having the dream. He seems to have had a psychotic break.  This is now  five nights since the vaccination. This morning at 4AM I found him sleepwalking outside in the snow in only a pair of jeans. No shirt, no shoes. No socks. Barefoot in the snow, waiting to be shot by ?them.?
Approx. 15 minutes after receiving the vaccine the patient complained of her heart racing, dizziness, nausea, scratchy throat.
Severe headache; muscle aches; muscle spasms; mild nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 54-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EP7533) via an unspecified route of administration in the right arm on 04May2021 at 13:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included scleroderma. The patient received an unspecified concomitant medications.  The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EP7533) via an unspecified route of administration in the right arm on 13April2021 at 13:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to 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 COVID-19 vaccination. On 04May2021 at 23:00, after the vaccination, the patient experienced severe headache, muscle aches, muscle spasms, mild nausea. The clinical outcome of the events severe headache, muscle aches, muscle spasms, and mild nausea was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
NECK PAIN (SOME DAYS IT HURTS MORE THAN OTHERS); 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: sulfa allergy, and other pre-existing medical conditions included: Patient never had this neck pain until received the janssen covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-SEP-2021, the patient experienced neck pain (some days it hurts more than others). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain (some days it hurts more than others). This report was non-serious.
dizziness; tiredness; Very sleepy; soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tiredness), SOMNOLENCE (Very sleepy) and VACCINATION SITE PAIN (soreness in injection arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C214 and 008C21H) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN B COMPLEX (B COMPLEX (B50)), VITAMINS NOS (DAILY VITAMINS), CALCIUM and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, 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 experienced DIZZINESS (dizziness), FATIGUE (tiredness), SOMNOLENCE (Very sleepy) and VACCINATION SITE PAIN (soreness in injection arm). At the time of the report, DIZZINESS (dizziness), FATIGUE (tiredness), SOMNOLENCE (Very sleepy) and VACCINATION SITE PAIN (soreness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes Ointment NOS.   This case was linked to MOD-2021-253194 (Patient Link).
Rotarix was administered via nasogastric tube; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a infant patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 29-AUG-2023, the patient received Rotarix lyophilized formulation. On 29-AUG-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Rotarix was administered via nasogastric tube).  The outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2023 The reporter reported that the patient received Rotarix vaccine administered via nasogastric tube in the critical care unit, which led to Inappropriate route of vaccination. The reporter did not had specific information about the patients or lot number of the reported vaccine. The reporter mentioned that in their facility they were vaccinated with rotarix vaccine between 2 and 4 months old. The reporter did consent to follow up via email. This US2023AMR118810 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR118810:same reporter
Was feeling fine before shot no symptoms of anything, took shot next day feeling run down chills coughing. that continued for 2 days.  The next few days feeling run down no energy still coughing  and today is one week still not up to normal yet.
pt recvd vax on 30MAR93 & on 14APR92 devel rt sided mumps; temp was 102.5 7 had an inc serum amylase;
Patient developed achiness, then diffuse swelling at immunization site within 24 hours of administration. When seen in office 48 hours later area of overlying erythema consistent with large local reaction to immunization vs cellulitis. Placed on course of Keflex and improved.
16 year old received the 1st dose of the Moderna COVID-19 vaccine; A spontaneous report was received from a healthcare professional, concerning a 16-years-old patient of unknown gender, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, a 16 years old patient who received the first dose of Moderna COVID-19 vaccine and now present for the second dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event "COVID-19 vaccine given to a 16-year-old patient", was considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 16-year old of unknown age who received her first of two planned doses of mRNA-1273 (Bach/Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Fever over 102,  severe migraine, malaise, nausea, full body pains
After receiving COVID-19, I experienced flu like symptoms with sore throat headache chills and fever. I was not pregnant at the time I had COVID-19 but was pregnant at the time of vaccination. Vaccination did not affect my pregnancy.
rt arm edematous (3x5mm size) x 24hr p/vax;pt called ER; pt called clinic 20OCT97 & reported redness in rt arm;pt arm was red from shoulder to elbow;rt arm cellulitis;swelling down arm from shoulder;allerg rxn;tired;yellow iodine stain;
Chills; Muscle pain; Chest pressure; Fatigue; Loss of apetite; Shortness of breath; Joint pain; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 26-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 left arm on 24Mar2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 20:00 the patient experienced chills, muscle pain, chest pressure, fatigue, loss of apatite, shortness of breath, joint pain, headache and fever. On 30Mar2021, the patient underwent lab test which included COVID-19 virus test (nasal swab) and the result was found to be negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events chills, muscle pain, chest pressure, fatigue, loss of apatite, shortness of breath, joint pain, headache and fever was recovered with sequelae on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 25-30 minutes after I left the site I had chills and started feeling weird. I had to pull over because I started to black out. Was seeing stars, ears ringing, sweating, and feeling heavy. Almost passed out completely. Slurring words  while talking to 911. Went to ER. Have felt heavy, arm sore, heart rate high, and tired after this event today.
Around 7 minutes following the injection,  I noticed the back of my tongue was swelling, then I noticed my throat was swelling.  When I swallowed, I could feel something in my throat.  My husband also said my eyes appeared bloodshot.  I drank some Dr. Pepper, I was able to swallow and symptoms did not increase.  Symptoms remained the same for about 45 minutes.  I then noticed the swelling of my tongue seemed to be improving, but I still felt my throat had something in it when I swallowed, and it was still swollen.  About 15 minutes later, my symptoms continued to decrease and were much better.   The next day after eating lunch, my throat seemed to feel swollen again, then my throat became sore.   By the day after that, symptoms had improved and were almost nonexistent.  Other very mild symptoms that I experienced were dull headache, fatigue, and soreness at the injection site.
Information has been received from a licensed practical nurse concerning a 7 year old patient who in 2002 was vaccinated with a dose of VARIVAX (Merck).  In May 2009, the patient developed a chickenpox outbreak.  Subsequently, the patient recovered from chickenpox on an unspecified date.  Additional information has been requested.
vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks). On 06-Jul-2021, PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-248540 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Updated patient demographics: Race; Updated route of administration of the vaccine: Intramuscular; Updated anatomical site: Deltoid;