chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm soreness; Diarrhea; Hot flash; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 24Feb2021 at 11:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included arterial spasm. The patient previously received collagen (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lysine (MANUFACTURER UNKNOWN), diltiazem hydrochloride (CARTIA XT), calcium (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and acetylsalicylic acid (ASPIRIN); all medications from an unknown date, unknown if ongoing and for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 10:30, the patient experienced right arm soreness, diarrhea and hot flash. 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 outcome of the events right arm soreness, diarrhea and hot flash were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash at injection site appearing 8 days later after arm hurting for 5 days; rash is now getting itchy
Shingles (Herpes Zoster); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 17Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to penicillin and sulfa drugs. The patient did not receive any medication within 2 weeks of vaccination. The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 12:00 (at the age of 39-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 09Apr2021 at 19:00, the patient experienced shingles (herpes zoster), which was diagnosed on 14Apr2021. The patient reported that he was a healthy fit 39 year old male with no underlying conditions. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir hydrochloride 1 gram for 7 days. The clinical outcome of the event shingles (herpes zoster) was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache tiredness; extreme weakness; chills; mild headache;  "poliuria" Narrative:  OTC Tylenol as needed; hydration and rest  Other Relevant History:
This report has been received from the healthcare professional and refers to a patient of unknown age and gender enrolled in patient support program. On an unknown date, the patient was vaccinated with MMR II (dose, frequency and route of administration were not reported). On an unknown date, during administration, the vaccine shot back out which caused dose to came out. Additional information has been requested.
Post vax, the patient's mother reported that the patient was "more irritable after the shot". The mother reported that the child "keeps on crying". Additional information has been requested.
Received vaccine on 1/26/2021 at 10:30am and at 2134 was observed to be having difficulty with breathing and cyanotic when staff entered his room.  He was coughing and sounded congested.  He was repositioner and SPO2 78% on room air so O2 applied at 2L which increased SPO2 88% so O2 increased to 4L and SPO2 increased to 95%.  Temp 103.1, B/P 188/110, resp 28, pulse 128.  911 called and sent to Community Hospital ER at 2145.  Received call from hospital reporting diagnosis of right sided pneumonia.   He had received his 1st dose on 12/29/2020.  On 1/8/2021 he was on droplet isolation due to possible exposure of Covid 19 and receiving duoneb treatments for chronic nonproductive cough.
Migraine headaches and uncontrolled blood pressure readings in the 150/90 range beginning The day after bivalent booster
very sore arm, low-grade fever, aches, chills the first night, profuse sweating the second night
Pt recvd vax & devel a fever of 102 orally & parents noticed a red rash on rt arm; according to the mom, red rash was from the area & warm to touch; parents took to MD; sl discolored like a bruise where swelling was;
Pfizer Dose 1 2/21/21 (EN6200) Pfizer Dose 2 3/14/21 (EN6207) COVID Positive 8/7/21  8/7/21: Presented to ED. This is a 75-year-old female with rheumatoid arthritis on methotrexate, Parkinson disease, tremors who presented with generalized body weakness and fatigue that has been worsening over the last 2 days. Patient has recently noted bilateral lower leg fullness and swelling of about 1 week duration.  Since yesterday she started to have fever, chills and cough for which she came to the emergency room and tested positive for COVID-19 infection.    She has been fully vaccinated with Moderna COVID-19 vaccine.  She takes methotrexate for her rheumatoid arthritis.  She denies any history of cancer, COPD, heart disease, trauma, thromboembolism, strokes.  She has no chest pain or known now history of coronary artery disease or congestive heart failure.  CT scan showed large pericardial effusion.  ED attending discussed with on-call Cardiology  Patient's symptoms at this time a not attributed to her pericardial effusion.  Cardiology and pulmonology  team is consulted and will additionally follow the patient  8/17/21: Patient is a very pleasant 75-year-old female who presented to the emergency department with complaint shortness of breath found to have bilateral community-acquired pneumonia secondary to COVID-19 infection complicated by acute hypoxic respiratory failure, although patient received COVID-19 vaccine however she was immunocompromised secondary to rheumatoid arthritis on methotrexate, echocardiogram was suggestive of large pericardial effusion however cardiogram ruled out tamponade, cardiology were consulted, patient was monitored.  There was no need for any intervention.  She received COVID-19 specific treatment.  She was on Rocephin and doxycycline to cover for pneumonia and E coli UTI.  Her symptoms significantly improved, for some time she was on heparin drip then transition to Lovenox and upon discharge will discharge with Xarelto.  Start evaluated by Cardiology who recommended follow-up with Cardiology as an outpatient and echocardiogram 3 months.  Patient did very well throughout hospitalization, worked with physical therapy and they recommended placement on patient was discharged in a stable condition without oxygen.
Vaccines stored in the refrigerator underwent several temperature excursions; No adverse event; Vaccines stored in the refrigerator underwent several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 25-Sep-2022 at 12:27 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 12:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions).    No concomitant medication was provided.  Patient received dose 4 at deltoid muscle.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No adverse reactions reported for the patient.  No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654537, US-MODERNATX, INC.-MOD-2022-670051 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654537:same reporter US-MODERNATX, INC.-MOD-2022-670051:same reporter
Received several travel immunizations on 10/23/08 had low grade fever on that HS.  On Wednesday and Thursday 10/29/08 and 10/30 /08 had 40 mm wheal with slight pain and very itchy.  Today w/ 40 mm erythema.  No SOB, no nausea no vomiting no systemic problems just local reaction
Pt was very calm prior to inject, but fainted p/it was done; Pt regained consciousness w/in 20-30seconds; had no further complications;
Very painful to injection site that woke me up the night of 12/17 into 12/18. Became febrile at 100.5F oral Friday 12/18 with body aches, joint pain, extreme fatigue, skin hurt between 4-5pm. 600 mg ibuprofen helped, however became flushed and sweaty.   Saturday 12/19 woke up feeling fine. Around 3pm, body aches started again with bilateral hip pain, extreme fatigue, sweating. Temp was 101.1F oral at 7:15pm. I took 500mg acetaminophen and 600mg ibuprofen.   Today, again woke up feeling fine at 9am, felt asymptotic. On the way to work at 10am, became sweaty/fatigued/body aches again. At work, 10:45am temp was 99.6F oral. I took 500/600 of Tylenol and ibuprofen.
Hospitalization on 9/3/2021 due to COVID19. Reported per Janssen COVID vaccine EUA.
Slight tightness in chest , nausea and metallic taste back of throat.  EMT visit patient refused transport to hospital.
Anxiety, headache, nausea, sweating approximately 15 minutes after injection. Observed 1 hour  emergency room then discharged.
H/a, chills, rigors, tight neck, generalized rash including scalp & palms, arthralgias, mild periph edema;
Developed headaches the morning after receiving the vaccine (6/16) The evening after the vaccine developed substernal chest pressure and dyspnea Symptoms continued intermittently for 4 das, then presented to emergency department Had a dry cough as well, did not have any fevers, chills, or myalgias On 6/19 chest pain and shortness of breath worsened, pediatrician advised to go to ED Admitted on 6/19 Labs showed elevated CRP, elevated troponin; repeat troponin elevated so patient received chest MRI and echo,  both negative (6/20) Patient received IVIG on 6/20  Currently admitted (6/20); clinically improved with improving chest pain, no shortness of breath
couple of hrs after shot R upper arm became very red, ran fever.(did not take temp); arm swollen. Treated with ice and tylenol. Also had complaint chest pain and sinus problems. Did not seek medical care, came back to clinic 11/2/01,830am. Pt arm (R) red and warm to touch below injection site. Recommended she call primary MD today.
Information has been received from a healthcare professional referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with VARIVAX (Merck) (confirmed Lot# K009759 and expiration date 09-JUL-2016; Lot# K018964 and expiration date 15-OCT-2016; Lot# L001335 and expiration date 13-JAN-2017; Lot# K018961 and expiration date 15-OCT-2016; Lot# K007972 and expiration date 03-JUN-2016; Lot# K010440 and expiration date 22-JUL-2016; Lot# K015943 and expiration date 23-SEP-2016, strength, dose, dose# and route not reported) that was improperly stored. No adverse effects reported. Additional information has been requested.
Patient came in for a flu shot with her partner on 10/02/21. She was alert and oriented before and after receiving the vaccine, only mentioning that she does not like watching the injection occur. After administering the shot, we had the couple wait at the store for 15 minutes based on the answers provided on their intake form.  The couple browsed around and seemed fine, then took a seat outside the store to wait the rest of their time. Pt then fainted, falling out of her chair and hit her head on a planter. ND attended to her and checked to ensure she was breathing and had a pulse, which she did. A bystander and the pharmacy called 911. Pt regained consciousness shortly after and we had her return to the store where she sat in the consultation room. There, she let us know that she has become dizzy or fainted after vaccines in the past and was not surprised by this response although it had not happened to her for several years. We offered her water and an ice pack for her head as we waited for the paramedics. The paramedics came and assessed her. She was hypotensive, slow to speech, and a bit pallor in appearance so they took over from there.   She later called the pharmacy about an hour later to let us know that she was fine. She did not end up going to the hospital but did spend time sitting with the paramedics until she felt better.
A few hours after receiving vaccination development of ear pain & fever. 11/18 developed otitis media treated with macrolides & cephalosporins; with later development of further fever and pharynitis 11/30/09 treated with cephalosporins (persistent otitis media); onset of flu-like symptoms 11/29-11/30, including sore throat, body aches and pallor, fast heart beat with fever on 12/2/09.
felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection; felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection; felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection; a little bit of soreness in the arm; This is a spontaneous report from a contactable nurse, the patient. This 66-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 05Mar2021 (at the age of 66-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration on 12Feb2021 (at the age of 66-year-old) as single dose for COVID-19 immunization. On 05Mar2021, the patient actually didn't feel anything until she showered that night, she experienced a little bit of soreness in the arm, she had forgotten that she had gotten a shot but she didn't take anything for it at the time. On 07Mar2021, she felt a lump under her arm, it was really painful and kind of swollen under the arm where had the injection, so she took two ADVIL on the same day. As of 08Mar2021, she had recovered from the injection site pain but her swelling and pain under her arm is ongoing but had improved a little bit with just the two Advil she took yesterday. Therapeutic measures were taken as a result of the events included two doses of ibuprofen (ADVIL). The clinical outcome of the vaccination site pain was resolved on 08Mar2021 while the pain in arm, vaccination site lump and vaccination site swelling was resolving.  No follow-up attempts needed. No further information is expected.
This case was reported by a nurse practitioner and described the occurrence of an exacerbation of hypertension in a 52 year old female patient who received hepatitis B vaccine recombinant (Engerix-B). The patient's past medical history included hypertension, joint pain and acid reflux. Concurrent medications included verapamil and hydrochlorothiazide for hypertension, naproxen for joint pain, sertraline (Zoloft) for an unspecified indication, and lansoprazole (Prevacid) for acid reflux. On 09 November 2004, the patient received the first dose of Engerix-B (lot ENG5588A4). Approximately one day following the administration of Engerix-B, on 10 November 2004, the patient experienced exacerbation of hypertension with a blood pressure of 172/105 mm HG. The patient was seen at a physician's office and the hypertension resolved on an unspecified date on or before 02 December 2004. The immunization series with Engerix-B was discontinued. The nurse practitioner considered the hypertension unlikely to be related to vaccination with Engerix-B. She reported that she suspects, "the naproxen taken at the time of the event caused the increased blood pressure."
Inflamed joints. Big toe on left foot. Both thumb joints are inflamed and very sore. Right side thumb is worse.  Knees inflamed.
20SEP93 mom in clinic & reports that pt c/o soreness in lt arm the evening got vax; next morning woke up c/o pain in lt arm & knees (more on lt); later broke out in red blotches; on entire lt side of body tried to see MD, but unable to;
Blurry vision; This has been a big problem for "me" and has been preventing "me" from doing many of the normal tasks "I" would do (including reading for long periods of time); Menstrual period was 2 days late (which is extremely rare); This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included tachycardia, bradycardia, mitral valve prolapse and migraines. The patient had no known allergies to medications, food, or other products. 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 magnesium (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and unspecified daily vitamin; all for unknown indications from an unknown date and unknown if ongoing. On 08Apr2021, 6 days after the first vaccine dose, the patient experienced blurry vision and had not gone away since (it had been two weeks currently at the time of this report). This had been a big problem and had been preventing patient from doing many of the normal tasks she would do including reading for long periods of time. The patient also reported that menstrual period was 2 days late (which was extremely rare). On an unknown date in Apr2021, the patient underwent brain MRI and the result was "nothing found" (issue persists). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events (blurry vision and big problem preventing from doing normal tasks) and included treatment with brain MRI. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurry vision was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Developed petechial rash to bilateral lower extremities, scattered petechiae to bilateral upper extremities 3 weeks after vaccination.  Denies all other medical complaints.
20 seconds after receiving shot, she started to convulse with seizure like symptoms- shaking, twitching, mouth open with tongue moving rapidly, eyes rolling back- she then passed out. When she came to consciousness, patient did not know what happened. She had confusion, tingling/ cold all over body, and weakness. She rested for about 15 minutes, and then felt ok enough to leave doctor's office.
Swollen arm near injection site; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm near injection site) and MYALGIA (Arm was sore) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm near injection site) and MYALGIA (Arm was sore). On 16-Jul-2021, VACCINATION SITE SWELLING (Swollen arm near injection site) and MYALGIA (Arm was sore) had resolved.        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.   No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.   This case was linked to MOD-2021-264236 (Patient Link).
Found unresponsive after coworker heard a thud.  Code Blue called.  CPR initiated, AED applied and no shockable  rhythm x3.  Code continued for 45 minutes with paramedics on scene and drugs administered. Time of death called by  ER physician on phone.