chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (severely ill), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (Shortness of breath), ASTHENIA (Weakness) and GAIT DISTURBANCE (Could not even walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (severely ill), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), GAIT DISTURBANCE (Could not even walk), DYSPEPSIA (Digestive problems), DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headaches). At the time of the report, ILLNESS (severely ill), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), GAIT DISTURBANCE (Could not even walk), DYSPEPSIA (Digestive problems), DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: high count of antibodies (High) high count of antibodies. On an unknown date, Heart rate: increased (High) Rapid heart rate. On an unknown date, Weight: decreased (Inconclusive) loss of weight. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
reporting an adverse event as the patient declined to provide any information; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reporting an adverse event as the patient declined to provide any information) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reporting an adverse event as the patient declined to provide any information). At the time of the report, VACCINATION COMPLICATION (reporting an adverse event as the patient declined to provide any information) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant product was reported.  no treatment product was reported.
Patient passed away unrelated to covid vaccine Narrative: The patient had hypertension, diabetes, hyperlipidemia and sleep apnea. Patient received first dose of Moderna vaccine 1/15/2021 and no adverse reaction was recorded. Clinical staff called to review patient's intent for second dose, patient is not interested and has elected to not receive second dose following clinical discussion of the risks and benefits of the COVID-19 vaccination. Patient was called on 2/17/2021 and his son stated patient passed away on 2/6/2021.Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Tiredness, headache,  injection site pain, upper arm pain, nausea - started within hours of first injection and lasted a couple of days.   Around 11:45pm the same day, I started feeling like I might pass out.  Vertigo when I stood.  Soon after vomited.  These later symptoms did not last very long.
patient reported experiencing fever of 101F and chills beginning in the early morning hours of 7/26/19
Pt was administered a total of three intradermal doses of Jynneos (total of  0.3mL). The first dose did not produce a visible wheal (so was considered invalid), upon the second ID  vaccination, a wheal formed and deflated quickly-- consulted doctor and she  recommended pt wait until the next day to see if a response would be evoked and  if not, another dose could be given then, however pt wanted administration of a  third dose with a visible wheal because was busy tmrw. Another dose was then administered
high fever of 105 for 3 days;sz (fever); no hx of sz in past nor family history;
patient ended up in the hospital; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media. This case involves patient (unknown demographic) ended up in the hospital (hospitalisation), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication 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 and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient ended up in the hospital (hospitalisation) (serious, unknown latency) after the administration of INFLUENZA VACCINE.  The reporter stated that Flu shot trying to kill and never again will get any kind of vaccine  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.; Sender's Comments: This case concerns patient (unknown demographic) who had hospitalisation after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
(L) thigh with erythemic area 10.5 cm x 9 cm long, mild edema present, non tender, mildly warm to touch.
Redness and swelling and streaking at injection site. Area of swelling increase over time, approx 7" by 5" wide. Low grade fever.  Zpack given, symptoms resolved.
My menstrual cycle began 2 days after my 1st injection. It was very heavy, heavier than a normal menstrual cycle for me. The only thing I can compare it to is the level of bleeding I had when I miscarried 4 years prior. This particular menstrual cycle  arrived 2 weeks early and only lasted 2 days. A typical menstrual cycle for me is normal flow for 4-5 days. Before the injection I had a very predictable cycle for 3 years. 28 days apart, moderate bleeding, 4-5 days in length.
Severe numbness in both hands mostly effecting both thumbs and first 3 digits; Puffiness in face; Puffiness around eyes; This is a spontaneous report from a contactable healthcare professional. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA6780) via an unspecified route of administration in the right arm on 07Jul2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, back pain, hip pain, sinus and allergy issues. 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 medications included allergy shot (MANUFACTURER UNKNOWN) and several other unspecified medications taken for unknown indications on unknown dates and unknown if ongoing. The patient previously took morphine hydrochloride (MORPHINE) for unknown indication on unknown date and experienced drug allergy. On 07Jul2021 at 20:00, the patient experienced severe numbness in both hands mostly effecting both thumbs and first 3 digits, puffiness in face and around eyes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the adverse events. On an unknown date, the patient underwent lab tests and procedures which included PPD tests and the result was found to be unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe numbness in both hands mostly effecting both thumbs and first 3 digits, puffiness in face and around eyes were not recovered at the time of this report.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. 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. On 04-Nov-2021 and 01-Dec-2021, the vial as initially stored in the refrigerator. The vial had not undergone any temperature excursions. This case was linked to MOD-2022-497308 (Patient Link).
On the 8th day after my vaccine, my arm started to swell just below the site of the shot.  These is a round shaped red rash, and the area is warm. I had no initial serious response to the vaccine.
Breakthrough case admission after 3 vaccines Moderna 11/22/21 Lot# 034F21A;  Moderna 12/20/21 Lot# 067H21A;  Moderna 8/30/22 Lot# 014B22A
ill; had two quarter size lumps on her neck; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 22 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administration date 17Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill"; MASS (non-serious), outcome "unknown", described as "had two quarter size lumps on her neck".  Additional information: My 22 year old daughter also got first shot next day and she was very ill as well as had two quarter size lumps on her neck for several days.  Follow-up attempts completed. No further information is expected.
Pediatric Hep B vaccine administered in error by assistant 0.5 instead of 1mL dose.
RCV'd vaccine 5/16/07. Pain at site 5/17/07 school nurse called because 2 1/2 inch red raised spot at site of vaccine. No fever, no red streaks, no purulent discharge.
Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; After 1st dose my left side was in pain; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Jul2021 19:00 (Lot number: EW0178) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: Codeine. The following information was reported: HEADACHE (non-serious), HYPOAESTHESIA (non-serious) all with onset 08Jul2021 21:00, outcome "recovering" and all described as "Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm"; PARAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06Jul2021 21:00, outcome "recovering" and all described as "Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm"; PAIN (non-serious) with onset 08Jul2021 21:00, outcome "unknown", described as "After 1st dose my left side was in pain". Therapeutic measures were not taken as a result of headache, hypoaesthesia, paraesthesia, pain in extremity, neck pain, pain in extremity.  Additional information: Patient did not receive any other vaccine in four weeks and not covid tested post vaccination. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient experienced left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. After first dose patient left side was in pain. After a few hours it became numb. Patient had a severe headache for days. This took place 7 days after the first dose. Patient received second dose of BNT162B2 (EW0177) on 22Jul2021 at 19:00 via intramuscular route, administered in right arm and after that patient had left numb on her left side and had a severe headache for 2 to 3Days.  No follow-up attempts are possible. No further information is expected.
TOOK 2 DOSES OF CRUSHED VIVOTIF; A spontaneous case report was received from a pharmacist on 16-Jul-2019 for three consumers.  Based on the information obtained from a pharmacist, three individual case safety reports PVX201907-000597 (PVX2019-1841; first consumer), PVX201907-000598 (PVX2019-1842; second consumer), and PVX201907-000605 (PVX2019-1864; third consumer) were created and cross-linked in the database.  This case describes a female consumer who "took 2 doses of crushed Vivotif" (PT: Wrong technique in product usage process). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid fever prophylaxis.  Case report: It was reported that the caregiver crushed first two capsules of Vivotif and gave it to the consumer. However, the consumer took the rest two doses normally.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 2 doses of crushed Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000597: US-PaxVax Berna GmbH-PVX201907-000598:
1) After both 1st and 2nd dose i had body ache , chills and tiredness and took about 1 week to go off 2)however after 2nd shot i have more permanent issues    - skin rashes and warts appeared on my elbow thigh and face region( warts)   - constant brain fog , this is not going away  I am planning to visit a doctor as these are not going away
Red bumps starting approx 2/17/08. More appearing over time, now in varying stages of varicella. No treatment.
This spontaneous report was received from a medical assistant referring to a 13 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-JUN-2015, the patient was vaccinated with the first dose of an unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported) (Product origin unknown). On 25-JUL-2018, the patient was vaccinated with the second dose of the GARDASIL 9 intramuscularly for prophylaxis lot number R003557 (dose, anatomical location and expiration date were not reported). No adverse effect was reported. However, lot number R003557 is valid for GARDASIL. The outcome of product origin unknown was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with GARDASIL 9 and the unspecified human papillomavirus (HPV) vaccine (manufacturer unknown).
Just like with first three shots I felt sharp stinging sensations in my upper abdomen and face. This time it was followed by large red patches including a large red patch on my face, as well as hives on my face and on a few of the red spots. They were itchy. The spots and itching lasted a few days. It was at its worst the first night and following day. The areas also felt warm to the touch. I also felt extra tired in the weeks following the injection.
This clinic was to administer Tdap as a follow up booster from the original DTaP but administered a DTaP to my child in error.  They realized the error in noticing the lot number did not align with the correct vaccine and a supervisor followed up with me explaining that DTaP can be given in place of Tdap if Tdap is not available. The instance of administering the DTaP was an error due to negligence at the clinic. Though there is unlikely to be a safety risk to my child due to this error, a clinic administering the wrong vaccine on accident should be reported. Additionally, the nurse withdrew the needle prematurely before administering the full dose and upon realization injected the needle back into my child to finish administering the remaining vaccine dose.
none. Nurse mgr/ApRN at Co. Health Dept. discovered that the above mentioned Pfizer vaccine was not properly removed from the regular freezer (25c to -15c) on 10/13/2021. The Pfizer vaccine was moved from ultra cold  freezer to regular freezer on 09/28/2021 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 to 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 removal from regular freezer. Patient was notified of the incident.  FNP-C Nurse manager Co. Health Dept
pt recv vax SEP95 & 7MAR97 pt presented shingles to MD office;it was reported that quite a lot of lesions were on the pt lt arm along the dermatome w/one lesion on hand;
Body aches, high fever.  At night chills, sweating, sore joints.  Symptoms continued until Friday.  Sunday slept late still had sweating/chills.  Right now have rash on both arms, swollen, scaly, raised, red; all the other symptoms subsided.
Patient diagnosed with Covid on 3/15/2023 and hospitalized on 4/8/2023 for acute hypoxic respiratory failure.
She states that her partner gave the dose and noticed that part of it went in, but part of it went out of the patient's arm; She states that her partner gave the dose and noticed that part of it went in, but part of it went out of the patient's arm; a fever of 99 F; This is a spontaneous report from a contactable pharmacist. A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in arm on 06Aug2021 (at age of 28-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller was a pharmacist who stated that they had a 28 year old male who may not have received a full dose of the bnt162b2 vaccine on (06Aug2021) Friday, and she wanted to know how to move forward with that. She stated that her partner gave the dose and noticed that part of it went in, but part of it went out of the patient's arm and based on the amount of liquid on his arm, they were estimating that it was less than half the dose. On that day, the patient wanted to wait and not get revaccinated. On an unspecified date in 2021, he had a fever of 99 F on Saturday, took Tylenol, and then felt fine on Sunday. Caller stated that with flu vaccines, if less than half the dose was given, they re-administered, so she wanted to double check regarding the covid vaccine. The patient underwent lab tests and procedures which included body temperature: 99 fahrenheit on an unspecified date in 2021. Therapeutic measures were taken as a result of the event fever of 99 f. Outcome of the event fever was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
fever, chills,  ---6 hours  headache, fatigue---3 days  nausea, pain at injection site  ---1 day
Numbness of upper extremities; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Thyroid disorder" (unspecified if ongoing); "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness of upper extremities". Additional information: Previously administered products included for COVID-19 immunization: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included Numbness of upper extremities with PFIZER BIONTECH COVID-19 VACCINE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother states the pt was seen in the ER at local hospital for hives on 3/11/00. She states he had "welts" only on left side of body, left leg and left side of back. Treatment of Benadryl and steroid injections. Now on prednisone, orally starting 3/12/00 an to completion on 3/17/00. No fever according to mother. She states that the child complained of his stomach hurting post injection.
diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Feb2021 15:55 (Lot number: EN6202, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension, start date: 1997 (ongoing); VERAPAMIL taken for hypertension, start date: 2016 (ongoing); CENTRUM VITAMINTS (ongoing). Vaccination history included: Bnt162b2 (Administration time: 15:45, Anatomical site of injection: Left upper arm, Route of administration: Intramuscular), administration date: 03Feb2021, when the patient was 56 years old, for COVID-19 immunisation, reaction(s): "Metallic taste". The following information was reported: DIARRHOEA (non-serious) with onset 25Feb2021 04:00, outcome "recovered", described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  No follow-up attempts are possible. No further information is expected.