chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and needles feeling at injection site; then ears itching; This is a spontaneous report from a contactable nurse, the patient.  A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via an unspecified route of administration, on 30Dec2020 at 03:45 AM (at the age of 63-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the right arm. Medical history included: History of Guillain Barre in 1970's with Swine Flu Vaccine. Concomitant medications included: clonidine (MANUFACTURER UNKNOWN), hydralazine ((MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination.  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. The patient previously took unspecified medications (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced sensitivity to some medications, and unknown if ongoing.   On 31Dec2020 04:15 PM, the patient reported "Within 30 minutes of vaccine, I had pins & needle feeling at injection site. Then ears itching followed by right face numbness from eyebrow to below chin with right mouth drop." The patient did not receive any treatment for the events. The clinical outcome of the events pins & needle feeling at injection site, ears itching followed by right face numbness from eyebrow to below chin with right mouth drop, was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the temporal association.
Woke up around 1:30AM shivering, cold sweats, indigestion and nausea that eventually lead to heavy vomiting at around 2:30AM. Later on around 8AM I got up for work and had a headache and moderate muscle fatigue.
Weird chest pains; Not hard to breath but sometimes it is; Has been down; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Weird chest pains), DYSPNOEA (Not hard to breath but sometimes it is), DEPRESSED MOOD (Has been down) and PYREXIA (Fever) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced CHEST PAIN (Weird chest pains), DYSPNOEA (Not hard to breath but sometimes it is), DEPRESSED MOOD (Has been down) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, CHEST PAIN (Weird chest pains), DYSPNOEA (Not hard to breath but sometimes it is) and DEPRESSED MOOD (Has been down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 04-JAN-2016, also reported as 05-JAN-2016, the patient was vaccinated with ZOSTAVAX subcutaneous, 0.65 ml, once. No concomitant medications were reported. On 04-JAN-2016, reported as right away, the patient experienced soreness, itchiness, redness at injection site. The patient used a OTC pain relief product (unspecified) as treatment. The patient sought medical attention by visiting the pharmacy. The outcome of pain, injection site erythema and pruritus was reported as not recovered. Additional information is not expected as no consent to contact the HCP was informed.
Arm is very red/Red circle of about 5 inches; Hot to the touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is very red/Red circle of about 5 inches), VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE PRURITUS (Itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced ERYTHEMA (Arm is very red/Red circle of about 5 inches), VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, ERYTHEMA (Arm is very red/Red circle of about 5 inches), VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.
Patient said as soon as needle went in there was pain & lots of bleeding - down arm. She can't lift arm up above shoulder - lots of numbness/throbbing pain
Went into atrial fibrillation for approximately 8 hours.  Went to local emergency room, condition stabilized while on the way there.  Follow up tests with cardiologist were negative.  It is unknown if this was directly related to the vaccine or just a coincidence.
Patient got COVID after the first dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) got COVID after the first dose of the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment drug were not reported.
Pt experienced pain in right shoulder since 3/1/00. Pt has had pains since then. Seen in Internal Medicine department on 5/15/00. Referred for an MRI.
patient to receive Shingrix vaccine. After RN re-constituted vial and drew up the reconstituted vial, she noted she only ad 0.2ml and it should be 0.5ml.
Blotching facial rash; clammy; fussy; guarding rt leg, won't ambulate, or use rt leg walk will draw it up, stand, crawl or turn rotate it, appears to have pain; Pt had a fall @ home 1hr p/immun, tripped & fell over an infant seat;
Woke up Sunday morning 02/21/2021 with cold chills, quickly turning to hot flashes, continuing with a severe headache,vomiting,diarrhea ,and nausea. Continuing thru Monday 02/22/2021 and Tuesday 02/23/2021. Called my Dr?s office at 9:00;AM 02/23/2021. Have not heard back. There message recording asks not to duplicate calls, which I did not do.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 18-SEP-2013 the patient was vaccinated with MMR II lot # 670592/0872AA, 0.5 ml, subcutaneous. The healthcare worker reported that the patient received an expired dose of MMR II. No adverse effect reported. Additional information has been requested.
Patient was just turned 12 at the time of vaccination and instead of receiving the 12+ Pfizer patient received Pfizer 5-11
Patient reported: Red, swollen area on arm, "low-grade" fever, malaise. Reported that this started the day after she received the vaccine. She also stated that she had some small, red pimples on her hand and trunk. These have resolved, and were not itchy. Patient denied any breathing difficulty.
I went to an annual Mammogram, and they found a lesion. They did a Needle Biopsy and there wasn't enough tissue for them to make a determination. Then they did Excisional Biopsy and determined that I have breast cancer. They next step is an MRI to find out if there any lymph nodes involved. After that there will be a treatment plan.
H/A, nausea, fever, cough, temp 97.8. Supportive care.
Delayed cutaneous hypersensitivity. Nine days after my first vaccination, my arm became pink, swollen, and sore near the injection site. It remains that way as I submit this form xxx days later. I'm expecting the issue to resolve at some point, but am submitting this report for information purposes.
I got the vaccine about 10 days later I felt a large lump on my collar bump and very weird feeling. I called my sister and advised me to go see my Dr. I saw my Dr. the next morning and he felt it and said it was my lymph node and collar bone that was swollen and its an indication that you have Cancer in abdominal area, and I have been getting coloscopy since 20 because I have pre-cancerous cells. He ordered a CT and MRI and colonoscopy. The colonoscopy came back clear. The CT or abdomen, collar bone all came back clear.  They did a EDG, that came back clear. The next step was a biopsy, and made an appointment to see a General Surgeon. It started to not be as large.  When I got my second dose it was very painful a red.  I'm still having issues but all test have came back clear. I have cancelled the General surgeon appointment, I really believe it's cause of the vaccine and all my test are clear.
short hypotonic rxn 3-4 hrs post dose; resolving when seen in ER;
EPILEPSY, UNSPECIFIED 8/2/2021 ALTERED MENTAL STATUS, UNSPECIFIED PULMONARY EMBOLISM, UNSPECIFIED. 8/23/2021 ALTERED MENTAL STATUS, UNSPECIFIED HYPOTENSION 1/5/2022 ALTERED MENTAL STATUS, UNSPECIFIED EPILEPSY, UNSPECIFIED 8/2/2021 EPILEPSY, UNSPECIFIED PULMONARY EMBOLISM, UNSPECIFIED. 8/23/2021 EPILEPSY, UNSPECIFIED HYPOTENSION 1/5/2022 EPILEPSY, UNSPECIFIED EPILEPSY, UNSPECIFIED 8/2/2021 ADULT OBSTRUCTIVE SLEEP APNEA, MILD PULMONARY EMBOLISM, UNSPECIFIED. 8/23/2021 ADULT OBSTRUCTIVE SLEEP APNEA, MILD HYPOTENSION 1/5/2022 ADULT OBSTRUCTIVE SLEEP APNEA, MILD EPILEPSY, UNSPECIFIED 8/2/2021 SEIZURE, UNSPECIFIED PULMONARY EMBOLISM, UNSPECIFIED. 8/23/2021 SEIZURE, UNSPECIFIED HYPOTENSION 1/5/2022 SEIZURE, UNSPECIFIED
No adverse even reported by patient but we did inform patient that the vaccine had been administered after its beyond use date.
Passed out and convulsed; Passed out and convulsed; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out and convulsed) and SEIZURE (Passed out and convulsed) 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 No adverse event (No reported medical history.).    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out and convulsed) (seriousness criterion medically significant), SEIZURE (Passed out and convulsed) (seriousness criterion medically significant) and VERTIGO (Vertigo). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out and convulsed), SEIZURE (Passed out and convulsed) and VERTIGO (Vertigo) outcome was unknown.            She received 2nd dose of Moderna vaccine 31 MAR 2021 and while she was at the pharmacy she passed out and convulsed, and later that night while at home she passed out and convulsed again.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
fever, crying, listlessness, swelling and pain at site of injection, mucous and blood in stool  to this day (11 years old), he still has stomach and gut issues and has accidents. He cannot feel when he has to have a bm and that started from this age.
Pt c/o pain at injection site and down arm upon exam was found to have lymphangitis and was prescribed Keflex 500mg TID x 7 days with cellulitis arm.
Fever (101), rash, joint and muscle pain primarily in my jaw, elbows, knees and lower back, and headache. I have never had a fever and rash with the last five Covid vaccines I have received.
After each dose of the Shingrix vaccine, I could not perform my normal daily activities (professional and personal). I had between 48-60 hours of side effects following each vaccine including: aches in shoulders, back, ankles and hands; fatigue; rash on neck, chest and back (itchy); headache; pain and redness at site of injection; and a slight fever.  It felt like I had the flu. I felt better about 60-72 hours after each dose of the vaccine was administered.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "positive for abnormal antibody- anticentromere b" (unspecified if ongoing), notes: positive for abnormal antibody- anticentromere b; "osteopenia" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "penecillin allergy" (unspecified if ongoing), notes: known allergies: penecilli. The patient's concomitant medications were not reported. Past drug history included: Erythromycin for Allergy; Cleocin for Allergy; Propofol for Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: several days later I began to have symptoms and tested positive; (unspecified date) Positive, notes: I also had COVID 1 month prior to this, took paxlovid and also had rebound. That time I had no sx, just a positive test; (01Mar2023) Negative, notes: After completing Paxlovid, 5 days of isolation and 5 days of making I tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took nirmatrelvir, ritonavir (PAXLOVID) from 19Feb2023 to 24Feb2023 as Treatment of COVID-19.
rash all over her body that is starting to peel; rash all over her body that is starting to peel; chills; fever; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN EXFOLIATION (rash all over her body that is starting to peel), RASH (rash all over her body that is starting to peel), CHILLS (chills) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever). On 09-Mar-2021, the patient experienced SKIN EXFOLIATION (rash all over her body that is starting to peel) and RASH (rash all over her body that is starting to peel). The patient was treated with PREDNISONE at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 19-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, SKIN EXFOLIATION (rash all over her body that is starting to peel) and RASH (rash all over her body that is starting to peel) had not resolved.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported
Received Tdap, HPV and MENACTRA in this order. When I turned to get the Varicella she fell from the chair to the floor, hitting her head. She was non-responsive verbally for several seconds. Her mother said she had a seizure as she fell. BP 112/60, P82. Mother took her to the ER. CT Scan was done. Patient is ok. Went to school yesterday per her mother.
Pain, swelling, redness sat injection site, radiating to neck & (R) armpit and then to (R) elbow and forearm. Area warm to touch.
Severe stomach pain, accompanied by explosive stools. That lasted for 2 1/2 days. Started a few hours after the 1st vaccine. Couldn't eat or drink without stomach pain occurring right after.
Tired. Muscle ache. Fever. Shivering (chills). Stomach discomfort.
Fever of 101F-102.3F for 14 hours, onset 7 hours post-vaccination (given acetaminophen)  Full body aches onset 7 hours post-vacinnation, ongoing Fatigue, onset 7 hours post-vaccination, ongoing Nausea, onset 10 hours post-vaccination, sustained 4 hours Dizziness and pre-syncope, onset 3 hours post-vaccination, sustained for 20 hours
woke up Sunday not feeling well. By late Sunday had fevers (100-102) and chills till fever broke Monday around 7 AM.  Monday after the fever broke noticed my toes were bluish grey. They were a pale blue grey on Tuesday. It appears the bluish color has begun to fade and is very faint today. Given a few more days I expect the color to return to normal.
Screaming nonstop for about 12 hrs; had to be held and rocked. Fever about 102 - gave TYLENOL.
minor muscle soreness during late afternoon - no treatment light Injection-site pain since late afternoon for 2...3 days - no treatment
Pain and swelling at injection site, sudden high fever, and fatigue. Rested for a few days and symptoms subsided.
This spontaneous report as received from a nurse reported that she had two providers at separate locations, administered expired vaccine. These two cases might have been already reported to MNSC but the nurse did not have any specific information regarding two cases and cases could not be located in USCC. PNEUMOVAX was administered two days past expiration date and ZOSTAVAX was administered 2 months past expiration date (lot # and exp date unspecified). No adverse effects reported. No treatment information was reported. The relatedness for used expiration vaccine is unknown for PNEUMOVAX 23 and ZOSTAVAX. The outcome of used expired vaccine is unknown. No additional information was provided. All drop-down fields apply for both PNEUMOVAX 23 and ZOSTAVAX.
Swelling [at the injection site that was] traveling down right arm from the injection site; Redness [and swelling at the injection site that was] traveling down right arm from the injection site; Redness [and swelling] at the injection site; Swelling at the injection site; Fever; Two vaccines administered in right arm; This is a spontaneous case initially received from other health professional on 17-Jan-2019, concerning a 26-year-old adult female patient.  The patient did not have any medical history.  On 14-Jan-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF43809 and expiry date: 30-Jun-2019) for protection against seasonal influenza. On the same day, the patient was also administered a non-company suspect vaccine Pneumovax [pneumococcal vaccine polysacch 23v, route of administration: intramuscular, anatomical location: right deltoid, dose, batch number and expiration date: not reported] for an unknown indication. Both the vaccines were given in same arm (right arm) (explicitly coded as drug administration error).  On the same day, after vaccination, the patient experienced fever, injection site redness and swelling which travelled down to her right arm. The patient was presented to the clinic on 17-Jan-2019 with the events. Patient was prescribed an antibiotic (Bactrim).   The outcome of the events was not recovered.  The reporter assessed this case as non-serious.  Non-significant follow up received from the reporter on 18-Mar-2019: It was reported that, the reporter was contacted on 11-Feb-2019 but was unable to obtain the information. The Med info reference number (SEQ19-00695) was updated in the additional information tab and no changes were made in the narrative.; Reporter's Comments: A 26-year-old female patient experienced swelling arm, redness, injection site redness, injection site swelling and fever on the same day after the administration of Afluria Quadrivalent and a non-company suspect vaccine Pneumovax on right arm (drug administration error). The company assessed the causality of the events (swelling arm, redness, injection site redness, injection site swelling and fever) as related to the suspect vaccine (Afluria Quadrivalent) due to plausible temporal relationship between the events and suspect vaccine. The company assessed the causality of the event (drug administration error) as not related to the suspect vaccine due to accidental nature of the event.
Father states pt c/o headache, nausea and vomiting, and diarrhea 6/26/2005. Father states headache persisted but nausea, vomiting, and diarrhea stopped 7/04/2005 and then on 7/04/2005 left arm and entire left side of body went numb. Hospitalized for 3 days. Father called health department 7/08/2005 to report this event. States son is still very fatigued and "not himself".  Information from medical records state myasthenia.
Received dose on 3.30.21.  Patient reported on 4.6.21 (at 23:57) that she has had tinnitus in both ears (since vaccination?) that has not subsided.
Lightheadedness and hot.  Evaluated by onsite paramedic and doctor.  Released by EMT and doctor continued to observe for 15 more minutes and then released home.
Pt recvd 3 doses of vax around noon; the same evening exp convuls regained consciousness on way to hosp;