chrisvoncsefalvay/vaers-outcomes huggingface dataset:
eyes swollen/eyes were swelling and lowered.; arm a little sore; eyes were tired/field of vision was not normal; sore; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes swollen/eyes were swelling and lowered.), PAIN IN EXTREMITY (arm a little sore), ASTHENOPIA (eyes were tired/field of vision was not normal), EYE PAIN (sore) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Osteopenia (The patient receives a shot for osteopenia every 6 month.). Concurrent medical conditions included Dust allergy, Allergy to molds, Pollen allergy, Allergy to animal (allergic to cats), Allergy to antibiotic (Allergic to Zipol and Lagil.), Grass allergy (grass and trees allergy) and Drug allergy (codeine). Concomitant products included GLUCOSAMINE for Joint ache, TRANEXAMIC ACID (NEXIM), MULTIVITAMIN & MINERAL, TOCOPHERYL ACETATE (VITAMIN E-400) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 22-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (eyes swollen/eyes were swelling and lowered.), PAIN IN EXTREMITY (arm a little sore), ASTHENOPIA (eyes were tired/field of vision was not normal), EYE PAIN (sore) and FATIGUE (fatigue). At the time of the report, EYE SWELLING (eyes swollen/eyes were swelling and lowered.), PAIN IN EXTREMITY (arm a little sore), ASTHENOPIA (eyes were tired/field of vision was not normal), EYE PAIN (sore) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient called to report swelling of bilateral testicles to twice their normal size within 24 hours of MMR. No pain or redness. Resolved 72 hours after vaccine.
a little sore at site of needle injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 68 years 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: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "a little sore at site of needle injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, FATIGUE Narrative:  STAYED HOME FROM WORK   Other Relevant History:
Patient reported that she began to have an itchy and swollen face approximately five hours after receiving her COVID bivalent booster and high dose flu vaccine.  She denied a rash.  Also denied difficulty breathing and any other symptoms.  She did not contact her doctor but has been taking Benadryl since the episode.  Continued to have an itchy and swollen face on 10/31/22.
Information has been received from a licensed practitioner nurse referring to a patient of unknown age and gender. On unknown dates the patient was administered the first and second doses of GARDASIL (dose, strength, lot# and route were not reported) series four years apart (inappropriate schedule of vaccine administered). The third dose in the three-dose series had not been administered. No adverse effect was reported. Additional information is not expected because the reporter did not wish to be contacted again for any additional information.
Incident occured 2/12/21 at approx. 9:40am. After pt received first dose of covid 19 vaccine was in RN monitoring waiting area. Pt was sitting in his WC and was observed to slump over in his chair which appeared to look like he was sleeping. Pt started heavy snoring like sounds. This writer approached patient to make sure that patient was feeling ok. Pt was not arrousable. Sternal rub performed with no results. EMS called.  Vital signs performed at 9:48am: BP-95/53 HR-60 O2Sat-96% CBG-170  Vital signs performed at 9:51am: BP-99/62 HR-60 O2Sat-96%  Vital signs performed at 9:54am: BP-99/63 HR-60 o2Sat- 96%  Pt was able to be arroused and open eyes at approx 9:51am. Pt once arroused was able to answer questons by shking head yes or no.  EMS arrived on scene at approx 9:55am and pt was transported to Hospital ED for further evaluation.
Child received a dose of covid from an undiluted vial. Provider contacted parent to inform them. Child's reported side effect was fatigue.  No symptoms reported by parent by 5 pm the next day.
MILD COLD LIKE SYMPTOMS.  MILD SORE THROAT, FATIGUE, MILD MUSCLE ACHES
HCP repors no further AE's; Administration of an expired dose of MMR Il; This spontaneous report was received from physician assistant referring to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies.  On 01-MAR-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), 0.5 milliliter one time (Expired product administered) (lot # T007230 was a valid lot number, expiration date was reported and established as 27-FEB-2022; vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis which was reconstituted with sterile diluent, 0.5 milliliter one time(lot# number and expiration date was not reported). There was no temperature excursions reported with this lot# of vaccine.  There was no further adverse event. No PQC. No additional information was reported.
HEADACHE; FATIGUE; fever 101.9; chills; nose dripping; cough; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE), FATIGUE (FATIGUE), PYREXIA (fever 101.9), CHILLS (chills) and RHINORRHOEA (nose dripping) in a male 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.     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 HEADACHE (HEADACHE), FATIGUE (FATIGUE), PYREXIA (fever 101.9), CHILLS (chills), RHINORRHOEA (nose dripping) and COUGH (cough). At the time of the report, HEADACHE (HEADACHE), FATIGUE (FATIGUE), PYREXIA (fever 101.9), CHILLS (chills), RHINORRHOEA (nose dripping) and COUGH (cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.9 (High) 101.9 fever..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details pertaining to the events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-051654 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051654:patient case
Facial swelling in eye, cheek, lips began on one side of face approximately 36 hours after vaccination and spread to other side of face throughout 2nd day after vaccination.
I began feeling light-headed within an hour of receiving the injection.  About 2 hours later, my arm began to ache.  By midnight, I had a headache, my arm was swollen, feverish and red at the injection site.  I seemed to be experiencing some central nervous system difficulties similar to how I feel when I take antihistamines (which I rarely take because of the side effects I experience) or albuterol.   My reaction time slowed and voices and loud noises jarred me.  That feeling has persisted for the past 3, almost 4 days even though it is diminishing.  This may not be life-threatening, but it has been somewhat debilitating.
I was at work and had no issues. My shift ended and got in the car 10 to 3 and was driving less than 4 miles away from my work. About 2.5 miles from work I started having severe chest, should, neck, jaw pain. I had difficulty breathing as well. I was afraid I wasn't going to make it to the hospital less than 1/2 a mile, pain level was 15 out of ten - that's how  bad the pain was. So I drove to the ER.  When I went in to the ER and they did an EKG and it came back negative, bloodwork 3 times - negative, Ddimer -negative, stress test- negative. The next morning I felt fine with no issues and I was discharged after the stress test and i went home. They put me in the CDU - 24 hr observation.
Approximately 12 hr after receiving vacinations, patient developed injection site soreness, erythema and induration in left arm where Pneumovax injection was given.  He also reported low grade fever, sore throat and malaise. By day 3, he reported feeling better and local reaction had improved some.
hallucinating; started to feel funny/acting weird/feeling weird mentally/no longer himself/didn't feel normal/everything went downhill; Paranoid; acting weird/no longer himself/everything went downhill; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), FEELING ABNORMAL (started to feel funny/acting weird/feeling weird mentally/no longer himself/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill). At the time of the report, HALLUCINATION (hallucinating), FEELING ABNORMAL (started to feel funny/acting weird/feeling weird mentally/no longer himself/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.  On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), FEELING ABNORMAL (started to feel funny/feeling weird mentally/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill). At the time of the report, HALLUCINATION (hallucinating), FEELING ABNORMAL (started to feel funny/feeling weird mentally/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill) outcome was unknown.  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
BURNING NOSE; WATERY EYES; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old male. Initial information was processed along with additional information received on 22-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 23-AUG-2022) dose was not reported, 1 total, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient received additional non-company suspect vaccine MRNA 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. No concomitant medications were reported. On 14-DEC-2021, the patient experienced headache, runny nose, fatigue, nasal congestion and patient felt only congestion until 20-DEC-2021 (subsumed under suspect covid-19 infection). On 15-DEC-2021, the patient also experienced burning nose, and watery eyes. On 17-DEC-2021, headache was resolved. On 18-DEC-2021, the patient had done home antigen test and for covid 19 tested as positive, hence had suspected clinical vaccination failure (Dose number in series 1 and 2).  The action taken with covid-19 vaccine ad26.cov2.s and MRNA 1273 was not applicable. The patient recovered from burning nose, and watery eyes on 18-DEC-2021, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint : 90000207979 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211244606-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Narrative:  COVID infection following COVID vaccine series 12/31/2020, Pfizer, dose #1 01/22/2021 Pfizer, dose #2 08/22 pt cc: fatigue, loss of taste or smell, dyspnea, exposure: unknown 08/23 pt admitted to hospital for covid PNA (non-agency) LOS: 1 day 08/24 COVID swab, result: detected 08/24 CXR Impression: No acute cardiopulmonary abnormality or change since December 2018. 08/24 SARS-COV-2 Variant Sequencing result: pending 08/24 pt admit ED cc: Cough, body aches. dx: Covid-19 LOS: 1 day 09/02 clinically resolved
Phone call received from pt's physician on 6/9/00, stating he saw infant on afternoon of 6/8/00, due to infant's excessive crying, which parent reported had lasted over 3 hours, post vax. States no other adverse reactions noted. Advised to omit Pertussis in future immunizations. Mom states infant received 1st dose of Hep-B in the hospital, at birth.
Dermographia, hives, swelling of feet, hands, lips, eyes, tongue and throat. Ordered to take 2 zyrtec and 2 pepcid a day. Prescribed a 5 day 40mg per day dose of Prednisone. Prescribed an epi pen due to throat, lip and tongue swelling. Swelling subsided with the prednisone treatment after 8 days. Hives, itchiness and dermographia continue to persist but are being managed by the zyrtec and pepcid. Breakthrough hives, itchiness and dermographia continue to persist, even with medication
10 minutes after administering flu shot, patient complained of swelling in eyelids, lips and throat getting tight.  Administered Benadryl and epinephrine.  Stabilized.  911 called and responded, patient taken to ED.
pt recv vax 7OCT95 & devel h/a, fever 101, malaise, arthralgias, myalgias, apple sized lump @ site w/tingling;next dose due 26OCT95;
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 03-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA004691: US-009507513-1708USA004692: US-009507513-1708USA004693: US-009507513-1708USA004694: US-009507513-1708USA004695:
Huge Gout Flare up not yet recovered Hip Infection MRSA cyst and pain better but not gone Injection site pain, hardness, discoloration still not recovered Body Pain, chills, dizzy, fatigue, GI distress
This spontaneous report as received from a office manager refers to a three unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the three patients were vaccinated with improperly stored doses of GARDASIL (lot, expiry date and dosing regimen were unknown). No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Little red bumps appeared a day after smallpox vaccine. After a few days, it became erythematous, papule and vesicle formations.
Stroke symptoms: intermittent ringing in ears and intermittent garbled speech, continuing to Jan. 2023
Redness, swelling, and warmth at site of vaccination (R vastus lateralis).
Covid booster given 5/26/22 was a 12+ Pfizer dosing instead of 5-11 yo Pfizer dose; nurse inadvertantly grabbed incorrect vial.
I received my COVID Moderna booster on 11/18. I had a mild fever overnight and then I felt fine. Starting on 11/27, I began breaking out in hives on my scalp and body that have since disappeared and reappeared throughout the day. I went to my dermatologist who brought up the COVID vaccine as a possible cause. Getting the booster is the only thing that has changed in my routine. I haven't eaten or used anything new that could cause full body hives. As of today, 12/6, I still have hives with no improvement.
Nausea, vomiting, diarrhea, headache, fatigue, muscle soreness
tinnitus in right initially and is now in left ear; Pain; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in right initially and is now in left ear) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus in right initially and is now in left ear) and PAIN (Pain). At the time of the report, TINNITUS (tinnitus in right initially and is now in left ear) and PAIN (Pain) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported
After getting the Johnson & Johnson shot at 3:15PM on Saturday (I did pass out at the vaccine clinic approx 2 minutes after receiving the vaccine and had to be escorted to a room to lay down) I developed chills, fever, and aches that night, but that's not what I'm reporting.  Sunday night, I developed painful red spots on my right inner labia. Monday morning, they had multiplied and darkened. I went in and saw my gynecologist, at 2:00PM. By that time they had worsened again. She could not immediately identify it, but swabbed it to test for herpes. She also prescribed an anti-viral, a rotating dose of OTC 600 ibuprofen and 500mg tylenol, and that I should pick up Orajel for topical numbing.  By Wednesday, the herpes test came back negative (as I expected, having never had herpes), and the spots had grown in size and turned into black and grey ulcers that were shedding with necrosis and were extremely painful. In addition, I was experiencing near exhaustion.  Dr. diagnosed them as Lipshütz ulcers. A severe immune response to the vaccine. In addition to the antiviral, she prescribed a steroid to help quiet the immune response and a few days worth of Hydrocodone to help with the very acute pain.  As of writing this on 4/20/2021, I am still not fully recovered, although Dr. believes it will be cleared up completely in the next couple of days.
Deltoid swelling and pain, pain with arm movement (much more significant than any other vaccine received), chills. Next morning and throughout day, joint pain in hips and knees as well as low back pain. Treatment--acetaminophen and heating pad.
Patient became pale, diaphoretic, nausea and did vomit.  EMS was called and on site at 11:45 am. Patient refused to be transported to local hospital. She stated she felt better.  Patient b/p 98/65, pulse 98, resp. 18 @ 11:35 . b/p 108/70, pulse 88, resp. 18@ 11:44. Patient was advised if she started  feeling bad  to go to local hospital. Patient verbalized understanding. I spoke with patient this morning and she states, she is feeling fine and has not  had any other issues  since.
Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history information reported .  Concomitant products included MEMANTINE HYDROCHLORIDE (NAMENDA), ASA, AMLODIPINE, ESCITALOPRAM, ATORVASTATIN, DONEPEZIL and VITAMIN D NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-060039 (Patient Link).
Shortness of breath, rapid heartbeat, tiredness and weakness, tingling in the face and extremities, could not articulate, swelling on the right side of the face.
12 hours after- injection site discomfort and headache  24 hours after - nausea, body aches, headache 7 days after- mild dizziness  10 days after- vertigo, much worse than the mild dizziness of day 7. Some nausea
Exposed to COVID19 after 1st dose of Moderna COVID19 vaccine; tender at injection site; headache; stiff neck on left side (underneath base of skull to neck and shoulders); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck on left side (underneath base of skull to neck and shoulders)), EXPOSURE TO SARS-COV-2 (Exposed to COVID19 after 1st dose of Moderna COVID19 vaccine), VACCINATION SITE PAIN (tender at injection site) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BUA) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck on left side (underneath base of skull to neck and shoulders)), VACCINATION SITE PAIN (tender at injection site) and HEADACHE (headache). On 26-Apr-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID19 after 1st dose of Moderna COVID19 vaccine). On 28-Apr-2021, MUSCULOSKELETAL STIFFNESS (stiff neck on left side (underneath base of skull to neck and shoulders)), VACCINATION SITE PAIN (tender at injection site) and HEADACHE (headache) outcome was unknown. At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID19 after 1st dose of Moderna COVID19 vaccine) outcome was unknown.        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.   Treatment was unknown.  Consent for follow-up with health care provider.