chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Employee presented to Occ Health for COVID bivalent booster. He was administered COVID Pfizer monovalent vaccine instead of COVID Pfizer bivalent vaccine.
hands and fingers started hurting and swelling with knots on the joints; hands and fingers started hurting and swelling with knots on the joints; hands and fingers started hurting and swelling with knots on the joints; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EN6198), via unspecified route of administration, in right arm on 17Feb2021 at 11:30 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included pacemaker (Cardiac pacemaker insertion), partial removal of thyroid and neuroendrocrine cancer (had neuroendrocrine cancer in 2013). The concomitant medication of the patient included Levothyroxine 75mcg, and metoprolol succinate ER Tab 25mg within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. Allergies to medications, food, or other products were reported as None.On 18Feb2021 at 05:00 the patient experienced hands and fingers started hurting and swelling with knots on the joints. Patient stated that her thumbs were especially bad where patient even had a hard time getting dressed. Patient didn't think much about it having anything to do with the COVID vaccine. Patient stated that she never had this problem with her hands and it was interfering with daily activities. Patient stated that her hand was bothering her. Patient was not able to open anything. Patient had trouble picking up things and drop them. Patient had hard time to pull pants up or button the shirts. The hands of the patient were ache constantly. The patient did not receive any treatment for the reported events. The patient had the physician office visit for the reported events. Patient received the dose 2 of BNT162B2 on 10March2021 at 11:30 AM in right arm with lot number EN620Y. The outcome for all the reported events was not recovered.  No follow up attempts are needed. No further information expected.
none Nurse Mgr/APRN at the Health Dept. discovered that the above mentioned Pfizer vaccine was not properly removed from the regular freezer (-25C to -15C) on 10/13/21. The Pfizer vaccine was moved from ultra cold freezer to regular freezer on 09/28/21 and should have been removed from the regular freezer the end of the day on 10/13/21 and placed in the refrigerator for 31 days. The vaccine was not removed on this day from the freezer. The vaccine is still in the freezer today 10/25/21. It was investigated and found that the vaccine was use in clinic Monday 10/18 through 10/23. NP called Pfizer Med and spoke with an attendant, walked her through the scenario and she made NP aware that vaccine could not be used past day 17 after being in the regular freezer, voice that vaccine stability could not be determined and that vaccine should not have been used past the 3 day grace or day 17 and should have been moved to the refrigerator on day 14 after removed from regular freezer. Patient was notified of the incident.
Patient cannot raise her right injection site arm above her arm.; Sweating; Soreness at the injection site; Lot of tiredness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Patient cannot raise her right injection site arm above her arm.), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (Lot of tiredness) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Patient cannot raise her right injection site arm above her arm.), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (Lot of tiredness). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Patient cannot raise her right injection site arm above her arm.), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (Lot of tiredness) outcome was unknown.            No concomitant medications were reported. In early 2022, patient received first primary Moderna monovalent COVID-19 vaccine. No treatment information was provided.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Feb 20, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed pain in extremity (her arm got sore), with outcome of recovered. Therapeutic measures were taken as a result of pain in extremity. Additional information: The patient stated with the first shot, her arm just got sore. She rubbed some alcohol on it and was alright. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Arm hurt; Upset stomach; Dizziness; Slept for hours; Had no energy.; Ached all over; Had a bad headache for days; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours) and ASTHENIA (Had no energy.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours), ASTHENIA (Had no energy.), MYALGIA (Ached all over), HEADACHE (Had a bad headache for days) and NAUSEA (Nausea). On 11-Mar-2021, PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), SOMNOLENCE (Slept for hours), ASTHENIA (Had no energy.), MYALGIA (Ached all over), HEADACHE (Had a bad headache for days) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported. Treatment details was not provided. Patient stated for a week after receiving the vaccine she ached all over and had a bad headache for days. She had an upset stomach and slept for hours. She had nausea and dizziness. Her arm was hurt and she had no energy.   This case was linked to MOD-2021-363322 (Patient Link).
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with doses of M-M-R II lot# reported as L037006, the expiration date: 26-APR-2018 (dose and route were not reported). There was no concomitant medication provided. Nurse reported that some of the administered doses of M-M-R II may had been reconstituted with improperly stored included sterile diluent prior to administration of M-M-R II. No adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested.
flu-like sx (nausea, vomiting, joint pain, h/a), sl jaundice lasting 4 days;
Very hard, very bright red/blue, very hot 3-4 inch diameter at injection site in arm.
On 04/09/1999 the pt developed fever. No rash. Two episodes of faling, no convulsive activity noted. On 04/10/1999 low grade fever. malaise and fatigue noted. On 04/11/1999 two seperate events of falling over from standing, generalized convulsive activity for approximately 3 seconds. Then crying and irritable for approximately for one minute. No fever. No further seizures.
swelling, red, size of a softball, itching, burning, painful at injection site  achiness and chills
A total of 5 Migraines in a 3 week period, starting the day following receiving the vaccine.  Normally have 1 every 1-2 yrs.  Migraines have subsided now.  Appointment with medical provider on 1/29/21
PATIENT RECEIVED HER FIRST FLU SHOT (FLUAD QUAD) ON 9/25/20. SHE THEN CAME IN SIX DAYS LATER AND ASKED FOR HER FLU SHOT. SHE RECEIVED TWO DOSE OF THE FLUAD QUAD IMMUNIZATION. PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS FROM EITHER IMMUNIZATION. DOCTORS OFFICE WAS NOTIFIED.
On 110519 (5 days post-vaccination), the patient presented with complaints of redness from the upper left arm to the elbow and initial signs of skin blistering, itchiness and "feels raw". She denied shortness of breath, difficulty swallowing, fever, diaphoresis. She was treated with a prednisone taper and hydroxyzine pamoate. The reaction was presumed resolved as the patient did not present any further complaints.
Patient developed hives that resolved over the course of 36 hours without treatment. Patient developed swelling and induction at injection site on left thigh 0.5 cm x 0.5 cm. Resolved without tx.
3rd dose / Her doctor has approved the prescription; Suspected vaccination failure; Mild case of shingles in July; Had itching; Had / scars; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 3rd dose of Shingrix. In July 2021, between 4 and 6 months after receiving Shingrix, between 7 and 9 months after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and scar. On an unknown date, the patient experienced off label use. The patient was treated with valaciclovir hydrochloride (Valtrex) and ascorbic acid (Vitamin C). On an unknown date, the outcome of the vaccination failure, shingles, pruritus, scar and off label use were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and scar to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the first dose of Shingrix vaccine November 2020 and second dose February 2021 . The patient got a mild case of shingles in July 2021, that affected her from her shoulders to base of her neck. The patient went to urgent care, got Valtrex, vitamin C for itching and scars.  The patient was currently at receiving a 3rd dose of Shingrix because the first two did not work. Advised Shingrix was only indicated for two doses and a third dose was not approved. The patient was  going to get the 3rd dose anyway as her doctor has approved the prescription and was preparing the dose for her which led to off label use. extra dose administered and off label use in unapproved indication. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
Five days after receiving the vaccine, I had a the worst outbreak of herpes, both oral and genital, at the same time, that I have ever had.
sick twice; Initial information was received on 12-OCT-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who was sick twice (Illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick twice (Illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.. Patient had been taken it for over 30 years. Patient have gotten really sick twice. And both times patient either had a temp or sniffles patient know if patient not feeling good, not take it.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Approx 4" raised, red, welt around injection site.  Lasted for several days post injection.  Note:  I photographed the welt 2 days after the injection, so am happy to share if desired.  Also slight fever on day following injection (100 degrees).  Pharmacist asked me to share reaction with VAERS.
Mother and child in for second set of vaccines on 05/05/2003. When asked if child had any reactions from previous set, mother replied he woke up about 2 AM after day of shots, shaking uncontrollably. No fever, alert. Fell back to sleep in about 45 minutes after first waking. Shaking lasted approx 45 minutes.
Patient screened by vaccinator and received the vaccine; began to sweat profusely > 10 minutes into the monitoring period. Staff of the skilled nursing facility assumed the assessment and monitoring due to condition change; charge nurse reports that patient's blood sugar was 234 in AM and now read 52. Hand Off communication was completed and City Staff did not have access to additional information past that time.
pt recvd vax; encouraged to wait 15 mins p vax; dad carried pt in clinic rm,pt was pale & diaphoretic;laid pt flat & elev legs;did answer questions when asked then would go to sleep;disoriented when awake;used smelling salts;to er for eval;
Swollen, red, hot area starting 2 inches below injection site. Not sure if related to shots but walk-in clinic gave KEFLEX just in case.
Hives on forearms, chest, and upper thighs, last 24 hours and went away with use of Benadryl
Facial paresthesia  - along right side of face from side of right eye ball down to the lip line and lips. As well as, headaches and at times facial paresthesia on the left side of face, as well. It was recommended to visit doctor multiple times. No treatment as of yet. These symptoms still happen from time to time.
Information has been received from a nurse concerning a 11 year old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported. no treatment medications were reported.
PATIENT SAYS SHE HAS BEEN SICK SINCE LAST VACCINE. SHE SAYS SHE HAS FEVER/CHILLS, NASAL CONGESTION, COUGH,HEADACHE, NAUSEA,VOMITING, DIARRHEA, CHEST PAIN, ACHES AND PAINS, AND LOSS OF TASTE ANS SMELL
Rt deltoid (SQ) soreness, redness in right arm on next day after injection. And unsure of other injection given to SM
Patient's tongue and lips started swelling and she was having problems swallowing and talking.  These  were primary symptoms she experienced while at the site. Emergency services were called and she was taken to the hospital.
Swollen lymph nodes under left arm pit; body aches; headache; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 31-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6205) via an unspecified route of administration in the left arm on an unknown date in 2021(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant mediations were not reported. On an unknown date in 2021, the patient experienced swollen lymph nodes under left arm pit, body aches, headache 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 outcomes of the events swollen lymph nodes under left arm pit, body aches, headache and fatigue were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers 77 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Dies of Cardiovascular Disease during Scrimmage; Initial information received on 27-Jan-2022 regarding an unsolicited non-valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 16 years old (unknown gender) patient who experienced dies of cardiovascular disease during scrimmage while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, frequency, lot number, route and administration site) for Flu. Information on the batch number was requested.  On an unknown onset and unspecified latency, the patient "died of cardiovascular disease during scrimmage" (cardiovascular disorder) following the administration of INFLUENZA VACCINE. This event was leading to death.  Reportedly, this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: Have you seen this list?? It goes on and on, and on.. it's happening everywhere, and is NOT normal!! 16 year old dies of Cardiovascular Disease during Scrimmage. It is unknown if the patient experienced any additional symptoms/events.  Final diagnosis was (fatal) dies of cardiovascular disease during scrimmage.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Dies of Cardiovascular Disease during Scrimmage).  At time of reporting, the outcome was Fatal for the event dies of cardiovascular disease during scrimmage. It is unknown if an autopsy was done. The cause of death was reported as Cardiovascular disease, unspecified.; Sender's Comments: Sanofi company comment dated 4-Feb-2022: This case concerns a 16 years old adult patient who was Dies of Cardiovascular Disease during Scrimmage, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: Cardiovascular Disease
Patient vaccinated with 2 doses Pfizer vaccine (3/2021 and 4/2021) and hospitalized with acute respiratory failure with hypoxia due to covid pneumonia in July 2021
Severe shooting stabbing ear pain in my ears every 40-45 seconds.; Patient received a third dose; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358A) via an unspecified route of administration in the left arm on 09Oct2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis and allergy to shellfish and iodine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included bupropion (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN); both for 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration on 06Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration on 27Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 09Oct2021 at 23:00, about 8 hour after booster shot, the patient had severe shooting stabbing ear pain in ears every 40-45 seconds. The event resulted in emergency room/ department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 10Oct2021, the patient underwent COVID-19 test via nasal swab and the result was unknown. Therapeutic measures were taken as a result of event and included treatment with fluids, unspecified pain medication. The clinical outcome of the event severe shooting stabbing ear pain in ears every 40-45 seconds was resolved with sequelae on an unknown date in 2021.