chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalization on dates 5/12/2022- 5/21/2022 for hypoxemia likely secondary to COPD exacerbation, positive for COVID 5/13/2022 . Treated with dexamethasone, methylprednisolone, prednisone
patient experiences left arm sore, pain, bruising,  redness after 1 week of vaccination. has self medicated with acetaminophen. spoken to her primary care and was told to rest and observe.
on 6-28 woke up with a swollen bottom lip. could not have been from something I ate as day before not feeling well and slept all day.
Got the vaccine in April,. 2021.  I don't have any underlying conditions at time of vaccine.   On or around June 25 I experienced a very severe dizzy spell while driving the likes of which I have NEVER experienced.  It managed to clear up with continual heavy breathing and just trying to get 02 in my body and specifically my head.   Also experienced gradual shortness of breath just walking around which I thought was unusual on June 26-27.  On the night of June 28th I experienced lower leg cramps in calf and foot area like I have never felt before.  On the morning I woke up and couldn't breath properly.  Off to hospital.  Blood clots both lungs and left leg.  Surprise.
pt recv vax & pt exp a gen rash;the nurse reported a total of 6 patients w/the same exp;
Headache, Sedation, Myalgia, Chills, Poor sleep,  Narrative: Following 1st dose on 12/31/20 noted lethargy starting 5 hours after injection which lasted 10/15 hours. Received 2nd dose on 1/26/21. Received 2nd dose on 1/26/21. Within several hours noted onset of chills. Also noted fatigue and headache with interrupted sleep that night. On 1/27/21 noted persistent fatigue, myalgias, and felt hot. Symptoms resolved afternoon of 1/28/21. Missed work x 1 day. No known prior COVID infection.
On Feb. 9, 2016  Pt. received the pneumonia vaccine and stated she had a lot of pain, redness and swelling afterwards. By Feb. 10th, pt. states "my left upper arm was swollen, red and hot to the touch, all the way down to my elbow, and including around the circumference of my entire upper arm." On Feb. 11th, about 10am, Pt came in to the facility to have arm assessed. The LVN assessed and subsequently said a doctor needs to see it. Dr.  examined my arm and determined cellulitis, caused by a bacterial infection, and ordered an oral antibiotic. After a few doses of the antibiotic the symptoms began to subside.
SEVERE pain starting in latissimus dorsi muscle, moving to shoulder/blade, down arm, severely in joints.  Then as that healed moved to right side in same fashion.  Then, back to left side (MOST SEVERE PAIN event) following same pattern, now in right side again.   Went to primary care physician (9-8), recommended rheumatologist (saw 9-20).  Determined it was a gout flare-up and recommended reporting
Body aches; Tired; Upset stomach; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Patient received other medications in two weeks, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 vaccination. On 13Apr2021 at 09:00, the patient experienced body aches, tired, upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events body aches, tired, upset stomach was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Erythema, induration, swelling, itching left deltoid! - treated for cellulitis with Keflex.
4" in diameter area of redness, tender & itchy. No infection advised Benadryl (at Varivax site)
The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022; administered an expired vaccine, 6 days after beyond use day; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine, 6 days after beyond use day ) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine, 6 days after beyond use day ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine, 6 days after beyond use day ) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Live follow-up contains significant information which included addition of secondary reporter, patient demographics (initial, age and gender), suspect product details (date of administration and batch number) and new event (product storage error). Also primary reporter details (address and city) and event description was updated.
Half dollar sized lump at injection site, area around injection site is very red and has a rash.  A week later the lump is slightly smaller but now bruised and red with same rash.
1 Day after injection (January 13) - bruising (no pain). Bruising has not gone away  8 Days after injection (January 20) - circle of redness, swelling and some itching below bruise. No or little pain. No lack of mobility in arm.
Pt recv vax on 3/24/98; 1 hr later pt exp swelling of L upper A for 9 dys; pain for 5 dys; fever for 2 dys; nausea, drowsiness, lethargy &headache.
general body aches, more in legs than anywhere else; described it as feeling like 'getting hit by truck'; fever of 99.2; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (general body aches, more in legs than anywhere else), FEELING ABNORMAL (described it as feeling like 'getting hit by truck') and PYREXIA (fever of 99.2) in a 28-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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN (general body aches, more in legs than anywhere else), FEELING ABNORMAL (described it as feeling like 'getting hit by truck') and PYREXIA (fever of 99.2). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1000 mg. At the time of the report, PAIN (general body aches, more in legs than anywhere else), FEELING ABNORMAL (described it as feeling like 'getting hit by truck') and PYREXIA (fever of 99.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Lab data includes Body Temperature 99.2 was added
UTI for Staphylococcus resistant to antibiotic onset 1 month after Pfizer booster vaccine. Symptoms: fever and dysuria.
R09.02 HYPOXEMIA 4/3/2023 CHEST PAIN R09.02 HYPOXEMIA 4/3/2023 CHEST PAIN
about 2 months after shot, my left ear started becoming clogged, like I cannot hear, it has increasing, and now my right ear is starting to follow
C/O right arm pain. 48-72 hours after injection lump felt where shot given. Hurts all the time. No relief with MOTRIN/ALEVE. Dr. diagnosis serum sickness like reaction to TDAP.
horrific headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrific headache) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053621A, 036A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, ATORVASTATIN CALCIUM (LIPITOR), APIXABAN (ELIQUIS) and TRAVOPROST for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (horrific headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at a dose of 625 milligram twice a day. At the time of the report, HEADACHE (horrific headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The headache woke me up on the middle of the night with such intense ache.
Metallic taste; numbness on left side of mouth; loss of taste completely; everything tasted like soap; Soreness up side of neck to base of skull and down back of arm to elbow; This is a spontaneous report from a contactable consumer. This 45-year-old female consumer (Patient) reported for herself. A 45-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FW0186, Expiration Date: not reported), via an unspecified route of administration in left arm on 16Jun2021 08:00 as single dose for COVID-19 immunization (At the age of 45-year-old, non-pregnant). Medical history included thyroid disorder and had allergies with just Sulfa and Vicodin. Concomitant medications included (Other medications in two weeks) ketoconazole (KETONE); colecalciferol (VITAMIN D) taken for an unspecified indication and thyroid medications. Patient did not receive any other vaccine in four weeks. The patient previously took vicodin and experienced drug hypersensitivity. Patient did not tested for covid prior and post vaccination. The patient experienced metallic taste, numbness on left side of mouth, loss of taste completely, everything tasted like soap, soreness up side of neck to base of skull and down back of arm to elbow on 16Jun2021 08:15. It was reported that, metallic taste followed by numbness on left side of mouth and loss of taste completely. When taste returned everything tasted like soap and numbness wore off. Soreness up side of neck to base of skull and down back of arm to elbow. Patient did not received any treatment. The outcome of the events recovering.  Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected
PATIENT IS ONLY 16 YEARS OLD. NOT APPROVED FOR PATIENT AGE.
The patient reported soreness in the right arm and it was warm.  She also said it was itchy.  It has diminished since the shot was given until she called today.
Body aches, headache, nausea, dizzy, extreme tiredness. Lasted from waking up the morning after shot until I went to bed. Woke up 2nd morning and felt fine
Patient under age 18 /Error in administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under age 18 /Error in administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under age 18 /Error in administration). On 19-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under age 18 /Error in administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Non-serious Case
Patient came in to get her second dose. Said that she had muscle soreness for over 1 month.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  A vial at was punctured 30 times at the clinic from which the vaccine had been given to the patient.
Arm was swollen and red. Painful to the touch. The day after injection, she went to doctor and was treated with antibiotics ad steroids.
i have had much more inflammation issues in my joints since having the vaccination. I would have mild right knee pain with little to no swelling, but since August 8 i have been experiencing a lot of swelling in my right knee, ankle,and elbow that remains for 10-12 days at a time. I have had to alter to my exercise habits due to the lack of flexibility in the joint.
pt recvd 2nd dose of vax & exp tightness of chest, SOB & numbness & tingling; given Epi & DPH sx cleared immed; 1/2 hr later reoccurred; escorted to ER by paramedics;
The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023; No adverse event; dose was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-May-2023, 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 10-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was stored in the fridge on 03-Apr-2023 and was administered on 10-May-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that was the 2nd Bivalent dose for the patient. No treatment information was provided.
The booster dose was administered today September 28, 2023. This is being reported as a possible late dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th September 2022), Twinrix (received 2nd dose on 15th September 2022) and Twinrix (received 3rd dose on 29th September 2022).   On 28-SEP-2023, the patient received Twinrix. On 28-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: The booster dose was administered today September 28, 2023. This is being reported as a possible late dose).The outcome of the drug dose administration interval too long 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: 28-SEP-2023 The reporter stated that patient received the first dose of the Twinrix accelerated dosing schedule last year.  This was being reported as a possible late dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient received 4th dose of Twnrix later than the recommended schedule, which led to lengthening of vaccination schedule. The case had been linked to US2023133823, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023133823:Same reporter, different patient
Administered with the vaccine from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which has been punctured for more than 12 hours) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which has been punctured for more than 12 hours). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.
pt recv vax; 2 hr later, exp stomach cramps, general fatigue, HA,d, flu-like sx & a fever; on am of 3mar94 T was 97; RN felt that there were a problem w/ the particular lot of vax;
Child received MMR on 7/7/14. After receiving vaccine had small welt at site of injection. Child was not complaining or having any itching, breathing problems. Applied ice for a couple of minutes. Area became larger - child was given 12.5 mg of BENADRYL. V/S remained stable - child was monitored for one hour. Left clinic with parent stable condition. Area didn't get any larger but did remain present.
grandma called amb p/diff arousing; when pt did wake up had a pitiful cry lt leg was reddened & swollen; t101.8R, pulse 200;
I developed shingles/ herpes zoster lesions on side of injection few hours post injection. I took valtrex once recognized issue.    Went to urgent care the next morning where they confirmed it was a shingles
It was discovered after vaccine (MMRV) was given, that the freezer temperature was out of the correct storage range.  Per manufacturer doses were compromised, therefore this MMRV is invalid.
Covid19 breakthrough.  1st vaccine received on 01/07/2021.  48 y/o male with PMHx of HTN, HLD, Type 2 Diabetes, Anxiety, depression and endocarditis presents to ED with c/o chest pain, intermittent headaches, myalagias, cough, sore throat, nausea, diarrhea, dizziness, weakness, and fatigue x4 days. T-100.3, CXR no acute process, room air sat 98%.  Treated with IV ABX and steroids.
Redness, induration, swelling of injection site. Developed about 36 hours after injection.
brain fog; Muscle pain; Nausea; Joint pain; Fatigue; Significant muscle pain at injection site began theday following injection and resolvedwithin 2-3 days.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 22Mar2021 at 15:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included mild PCOS, mild asthma. The patient did not have any known allergies to medications, food, or other products. Concomitant medications included OVASITOL received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced nausea, muscle aches, joint pain, fatigue, brain fog and vaccination site pain. The patient did not receive treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was resolved on an unknown date in Mar2021. The clinical outcome of events, nausea, muscle aches, joint pain, fatigue and brain fog was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.