chrisvoncsefalvay/vaers-outcomes huggingface dataset:
we gave a vaccine to a patient today and it expired with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient where we gave a vaccine to a patient today and it expired with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 25-Jan-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (batch number- U6922AA) via unknown route in unknown administration site (dose, frequency, route, strength and expiration date: not provided) as Immunization.  On 25-Jan-2023 the patient had developed a non-serious we gave a vaccine to a patient today and it expired with no reported adverse event (expired product administered) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event we gave a vaccine to a patient today and it expired with no reported adverse 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.
Grapefruit sized localized swelling with redness, pain, heat at injection site, duration 4 days. Responded to antiinflammatories.
I have floaters- right eye. I never had these before. Started the evening that I received the vaccine. on 8/3/22 They have not subsided.   I will be seeing an eye doctor. I have not been able to get an appointment yet.  I did have COVID twice.  Once before the vaccine.  The second time was after receiving two doses of the vaccine. I am also a registered nurse.
Fever, chills, sore arm at injection site, and intense body aches starting 12 hours after injection. Treated with acetaminophen.
the consumer developed a "measles-like reaction" following MMR-11 administration; This spontaneous report was received from a nurse practitioner referring to a 12 months old male patient. There were none concomitant medication, pertinent medical history and drug reactions and allergies.   On 04-FEB-2021, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (strength was not provided, lot# was T001211 and expiration date was 20-NOV-2021), 0.5 ml with sterile diluent (manufacturer unknown) (strength, lot# and expiration date was not provided) 0.5 (unit not provided) subcutaneously for immunization.    On the same day, the patient developed a measles-like reaction following measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration. Medical attention was sought. Ibuprofen was given as treatment.   The outcome of the event was not recovered. The causality between the event and both therapies was not provided.  Upon internal review, the event of measles was determined to be medically significant.
approx 3 1/2-4 hrs p/vax pt leg became erythematous & pt very irritable prior to leg erythema; had cried for 3-4 hrs p/vax;
This spontaneous report was received from social media, refers to unspecified number of young male patients. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, expiry date and lot # were not specified) for prophylaxis. On an unknown date, the patients experienced injury (majority injuries) and pain (unfathomable pain). On an unknown date, the patients died due to unknown reason. It was also reported on an unknown date that, dangerous bills were passed to mandate the suspect GARDASIL (lethal injection)  and also allow the minors to receive without "Parental Consent" as prophylactic treatment to prevent STD's (sexually transmitted diseases) in millions of boys in more than 52 countries around the world. The outcome of pain and injury was unknown. The causality assessment was not reported. This was one of the several reports.
Post vax, the pt developed swelling of right leg from hip to knee. No pain, redness, or loss of function.
Lost complete uses of left arm from shoulder to elbow. Could not lift arm from side, overhead.; Pain throbbing pain with a pulse from arm; 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: Ew0153) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and NATURE BOUNTY HAIR, SKIN, NAIL VIT both for unspecified 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 14Apr2021 at 00:00, on tenth day after vaccine the patient lost complete use of left arm from shoulder to elbow, could not lift arm from side, overhead and pain throbbing pain with a pulse from arm. She waited for two days in pain and went to urgent care. On 17Apr2021, the patient underwent test which include X-ray to see if something strange, even though no new activity and nothing was found. She was advised to continue taking over the counter ibuprofen (MANUFACTURER UNKNOWN). Arm was still not 100 percent limited use at best and throbbing had subsided. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as the result of events and included treatment with steroid injection (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN). The clinical outcome of the events lost complete use of left arm from shoulder to elbow, could not lift arm from side, overhead was not recovered ; while that of pain throbbing, pain with a pulse from arm was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Heavy arm; Could only move arm in one direction; Bruise; Scab; rubbing the injection site to hard can have any effect on the vaccination; soreness at the site of injection; vaccination site bleeding; skin inflamed after the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE HAEMORRHAGE (vaccination site bleeding), SKIN BURNING SENSATION (skin inflamed after the second dose), LIMB DISCOMFORT (Heavy arm), MOBILITY DECREASED (Could only move arm in one direction) and CONTUSION (Bruise) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and MEBENDAZOLE (WORM TREATMENT) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (vaccination site bleeding), SKIN BURNING SENSATION (skin inflamed after the second dose) and VACCINATION SITE PAIN (soreness at the site of injection). On an unknown date, the patient experienced LIMB DISCOMFORT (Heavy arm), MOBILITY DECREASED (Could only move arm in one direction), CONTUSION (Bruise), SCAB (Scab) and VACCINATION SITE INDURATION (rubbing the injection site to hard can have any effect on the vaccination). At the time of the report, VACCINATION SITE HAEMORRHAGE (vaccination site bleeding), SKIN BURNING SENSATION (skin inflamed after the second dose), LIMB DISCOMFORT (Heavy arm), MOBILITY DECREASED (Could only move arm in one direction), CONTUSION (Bruise), SCAB (Scab), VACCINATION SITE INDURATION (rubbing the injection site to hard can have any effect on the vaccination) and VACCINATION SITE PAIN (soreness at the site of injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.   This case was linked to MOD-2021-100916 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: follow up received on 29-apr-2021 new concomitant medications , events were updated. On 30-Apr-2021: follow up received on 30-apr-2021 new events were added.
I started to get minor heartburn; I was then woke up 4 times each night with major heart burn.; Last night I was awaked 1 time.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration in the right arm on 14Apr2021 at 14:30 (at the age of 40-year-old) as a single dose. Medical history included depression and penicillin allergy. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, one day later in the evening, the patient experienced minor heartburn. The patient woke up 4 times each night with major heart burn. The patient felt that the only way to sleep without having it was to sleep sitting up. That night the patient was awakened once and took turns for it which helped the patient. The patient also reported that if it would not had been for a weekend she would have gone to her doctor. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 minor heartburn, major heart burn and disturbed sleep was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
No additional adverse effects reported.; the patient was administered improperly stored Varivax; This spontaneous report was received from a nurse and refers to a 17-month-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-AUG-2020, the patient was subcutaneously vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032352, expiration date: 14-OCT-2021 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 2 hours and 30 minutes in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit (10.9 F) on an unknown date prior to administration. There was no previous temperature excursion. Digital Data Logger was involved.  No additional adverse effect was reported.  The outcome of medication error was unknown.
doses were given after expiration date; Vaccine expired on 13 Oct 2021, vaccine placed in refrigerator on 18 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021,vaccine placed in refrigerator on  18 Oct 2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021,vaccine placed in refrigerator on  18 Oct 2021). On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021,vaccine placed in refrigerator on  18 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitants medications were not reported. Date the vial was placed in the refrigerator was 18 Oct 2021.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Patient did not experience any adverse events. Treatment information was not provided.
Started red welps on rt/left thighs afternoon on day of injections, worse on next day. 3/25/13 3-4 bullae, swelling extending most of bilateral thighs.
Received prescribed vaccine 7/16/14. Developed swollen, red arm in hours. No fev. Pain 5/10.
Patient is fully vaccinated. 8/11/2021- congestion/diarrhea/headache. 8/12/21- Tested positive for Covid
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/21/2022 ASTHMA, UNSPECIFIED J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/21/2022 ASTHMA, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/21/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/21/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Patient informed us that she wasn't feeling well within 5 minutes of getting the Pfizer vaccine (vaccine given at 11:16am PST). She stated that she had difficulty breathing, her heart was racing and she had a headache. We asked her if she wanted us to call 911 and she said yes.   I called 911 and also grabbed her a bottle of water. She wanted to sit inside the counseling room while waiting for the medics to arrive.   The paramedics arrived at 11:38am and they checked her vitals and consulted with the patient. After about 10 minutes, they informed me that the patients vitals were all normal except for her blood pressure being high. They also said her housemate will come by and pick her up and she was okay to go home.  I told the patient she can wait in the counseling room for her housemate to arrive. Also asked if she needed anything else while she was waiting. She said she didn't need anything else. Her housemate came by and she left
March 12, 2021 10:05am received vaccination,  after 5min my left arm went numb. Nothing till a week later, March 19, 2021 woke up with a really red and hot also very itchy upper arm and swelled. Later that day my inoculation area swelled to the size of an oblong soft ball got so hard I had indentions all up and down my arm 1/2 way to my elbow.  It  is still red, hot,  and itchy, not quite as swelled this is Mon. March 22, 2021.
Information has been received from a nurse concerning an 11 year old male with attention deficit/hyperactivity disorder (ADHD) and penicillin allergy who on 23-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). Concomitant therapy included FOCALIN. After receiving the vaccine, the patient experienced redness and swelling of his left arm at the injection site. There were no lab diagnostic studies performed. The patient sought medical attention via visiting to school nurse. The patient's redness and swelling of his left arm at the injection site persisted. Additional information has been requested.
A non-serious spontaneous report of "we gave H1N1 LAIV to a woman who is pregnant" was received from a registered nurse concerning a 24-year-old pregnant female. The patient had no past medical history. The patient's concomitant medications included prenatal vitamins, Rho(D) immune globulin, vitamin C and iron during the pregnancy. The obstetrical history included gravida two and para one. Gestation period at the time of vaccination was 15 weeks and four days. She was in her second trimester of pregnancy with the estimated date of delivery as 10-Jul-2010. On 20-Jan-2010, the patient received the H1N1, Intranasal for an unknown indication. On 16-June-2010 at 39 weeks gestation, the patient vaginally delivered a female infant. The infant weighed seven lbs & four ozs; apgar at one minute was eight and at five mins was nine. There were no complications at delivery for mother or the infant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of vaccine exposure during pregnancy was considered resolved. This case is linked to MEDI-0011481. Additional information was received on 12-Feb-2010 and incorporated in narrative: Patient history, concomitant medications, obstetrical history, LMP date and expected delivery date received. Other additional information received: Reporter title and address. Additional information received on 16-Aug-2010 and incorporated in narrative: Pregnancy outcome, concomitant medications and infant information. Other additional information received was Reporter information, patient name, responsible physician information.
Patient noticed a huge lump on left side above shoulder blade and neck and right below left ear; Fever, chills, body aches, felt over all sick; Fever, chills, body aches, felt over all sick; Fever, chills, body aches, felt over all sick; Fever, chills, body aches, felt over all sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Fever, chills, body aches, felt over all sick), SWELLING (Patient noticed a huge lump on left side above shoulder blade and neck and right below left ear), PYREXIA (Fever, chills, body aches, felt over all sick), CHILLS (Fever, chills, body aches, felt over all sick) and MYALGIA (Fever, chills, body aches, felt over all sick) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ILLNESS (Fever, chills, body aches, felt over all sick), PYREXIA (Fever, chills, body aches, felt over all sick), CHILLS (Fever, chills, body aches, felt over all sick) and MYALGIA (Fever, chills, body aches, felt over all sick). On 28-Feb-2021, the patient experienced SWELLING (Patient noticed a huge lump on left side above shoulder blade and neck and right below left ear). At the time of the report, ILLNESS (Fever, chills, body aches, felt over all sick), SWELLING (Patient noticed a huge lump on left side above shoulder blade and neck and right below left ear), PYREXIA (Fever, chills, body aches, felt over all sick), CHILLS (Fever, chills, body aches, felt over all sick) and MYALGIA (Fever, chills, body aches, felt over all sick) outcome was unknown.            no treatment product was reported The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
pt recv vax;mom reported Pt had sz like activity,lasting only few sec;no fever w/ sz;this occurred 2 wk p/ vax;
Information has been received from a registered nurse concerning a 6 year old female patient with no allergies and no past medical history who on 08/25/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  There was no illness at the time of vaccination.  On 04/07/2004, the patient developed breakthrough chickenpox (also reported as varicella) with multiple lesions on her face, extremities and trunk.  Unspecified medical attention was sought, but treatment was not required and laboratory tests were not performed.  Subsequently, the patient recovered.  A product quality complaint was not involved.  Additional information is not expected.
Patient received her second Covid immunization on 6/27.  On 6/28, she developed fever, myalgias, headache, and vulvar pain.  On 6/30, she was diagnosed with acute vulvitis, which evolved by 7/2 to acute genital ulcers.
Pt seen 7/5/17 with H-F-M disease. Pt seen on 7/10/17 with Acute Pharyngitis/rash secondary MMR with fever.
This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. The medical assistant reported that the patient receive doses of GARDASIL 0.5 ml (route, lot number and expiration date not reported) outside of the recommended schedule. She stated that the patient received her first dose in November 2012, her second dose in December 2013 and her third dose on 03-JUL-2014. No adverse effects reported. Additional information is not expected.
Calls to say is declining 3rd Gardasil  Still having shoulder pain from 2nd inj.   Day of 1st inj and after no sx.  2nd inj: day of inj headache ,nausea, sore arm.  Severe pain con't at injection site for 1 wk.   If rolled on arm would wake her up do to the pain.  If leaned on Rt elbow would get referred pain in rt shoulder and at inj site.  Pain intermittently con't in right shoulder and inj site.  Feels some of pain is in shoulder Joint. This pain con't thru today though is intermittent.  Pt did not seek Tx of any kind and this is the first time she is reporting this to a medical provider.  Pt wants adverse reaction form completed.   Form found on WIR Web site.  Pt understands information will be sent to CDC and FDA where information on adverse Rx form  Her identity will be kept confidential. Pt to call back if Sx do not go away. Pt. expresses understanding will follow above plan.
Dose 1 given on 3/18/2021, Dose 2 given in error on 4/8/2021.
Pt was given 2nd dose of Pfizer instead of 2nd dose of Moderna. Charge RN and pharmacist were alerted. Patient was alerted and assured they are safe even though different 2nd dose was given. Pt with no adverse signs or symptoms
Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB) after running outside around a lake. No previous history of anaphylaxis or allergies. Reports that she had her COVID-19 vaccine 1 week ago. and had question about if that could have contributed to the event.