chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a terrible cough and terrible headache. I also had running nose and my O2 stats dropped to 83. I was feeling very fatigue that I kept falling asleep. I took vitamins, Tylenol, and Ibuprofen for the pain and symptoms. The medication did not help for my headache at all. My symptoms lasted for about two months or so and I still have the cough today. My O2 stats still remain high (88).
Only ate one meal; Hard to move it; Itchy neck; Rash all over my neck, down to my arms and up to my breast area; Slept all day; Really tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), DECREASED APPETITE (Only ate one meal), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it), PRURITUS (Itchy neck) and VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Really tired). On 15-Apr-2021, the patient experienced SOMNOLENCE (Slept all day). On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itchy neck) and RASH (Rash all over my neck, down to my arms and up to my breast area). On an unknown date, the patient experienced DECREASED APPETITE (Only ate one meal) and VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept all day), DECREASED APPETITE (Only ate one meal), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move it), PRURITUS (Itchy neck), VACCINATION SITE PAIN (Sore arm), RASH (Rash all over my neck, down to my arms and up to my breast area) and FATIGUE (Really tired) outcome was unknown.            Concomitants were not reported.
100.3 fever, can't breathe out of nose, sore throat, cough headache, chest hurts whole body aches
getting headaches, dizziness, swollen eyelids, shortness of breath, diaherra and vomiting
Menstrual. Large clots throughout entirety of period m, larger than ever before, about the size of my palm before was smaller than quarter on first two days never longer. Increased flow, increased  days between period and increased number of period days. Worse cramping and bloating. Overall periods much worse in all aspects.
10x12 redness & warmth around injection site. Fever of 102 degrees on 6-27-12 & 101 degrees on 6-28-12 body aches severe.
Pt received his 3rd Moderna booster on 11/5/21 after receiving his two prior vaccines on 3/19/21 and 4/16/21. He developed left leg swelling on 11/10/21 which progressed to right sided pleuritic chest pain on 11/11/21. Ultimately he was diagnosed with left lower extremity DVT and right sided pulmonary emboli and right sided pulmonary infarction.
Fever over 100 degrees, muscle aches, injection site pain, fatigue, headache, nausea
Patient has macular degeneration in the right eye.  A normal functioning left eye.  Ringing in the ears (but constant due to loss of hearing)  After getting the shot within 4 days after receiving the patient has had a decrease in vision in the left eye.  He has trouble reading and trouble focusing.  He said he also has constant ringing in the ears, but cant determine if that is from hearing loss, or the vaccine.  Vision was blurry, and to see/read the patient needed to look to the left of it to see it.  He couldn't see it by looking directly at it.  He said colors were more vibrant and when closed he could see "thousands" of little specs floating around.
elevated temp on & off since 2SEP98 to  103 5SEP98;rash 8SEP98;
Memory impairment; Balance difficulty; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impairment) and BALANCE DISORDER (Balance difficulty) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory impairment) and BALANCE DISORDER (Balance difficulty). At the time of the report, MEMORY IMPAIRMENT (Memory impairment) and BALANCE DISORDER (Balance difficulty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-Significant follow up appended to AER
pt w/area of 3" x 5" redness & warmth on lt upper outer arm; also had fever, nausea & vomiting seemed to have a stomach flu start day p/vax;
Headache immediately after immunizations, dizzy, balance issues. Patient subsequently seen in ER for further eval.
Rash, blisters, and discomfort of Shingles outbreak on the left buttocks. Diagnosed at Dr. visit 2/17/2021; Treated with Medication for 7 days.   Discomfort has improved but remains somewhat uncomfortable.  Rash and blisters have diminished but are still visible.
Patient had moderate swelling R deltoid, TTP. LT prescribed BENADRYL 25mg q6hrs for TX.
Developmental speech Apraxia sensory integration/ Fine motor control Occupational therapy until 02/26/2000. Speech therapy. Mild autism
At 8:00 P.M. that night she used her walker to go to the bathroom. After 5 minutes I went in and found her walker at the comode,and she was standing 20 ft. away at the bed mumbling O.K. o.k. and that was all she said. I called  911 and she was taken to The Hospital where she is currently in ICU on a respirator.
I began menstruation 3 hrs after the injection. I am still bleeding, 21 days later.  I have no history of this. I also already had my menstrual cycle in June - so this began a new cycle of bleeding.
Tingly left side of my lip and cheek by my ear. Very mild but noticeable. Never became worse. Still think I feel the tingle 24 hours later.
Patient began feeling tingling in hands and fingers. Their hands and feet began to swell and turn red.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # M039202 and expiration date 11-MAR-2018 and lot # N008823 and expiration date 26-MAY-2018  (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA002048: US-009507513-1709USA005380: US-009507513-1709USA005382: US-009507513-1709USA005379:
On 12/30/04 developed back pain. 1/2/05: facial and leg paralysis. Guillain Barre diagnosis.   4/7/05 Discharge summary received for 1/2-1/7/2005 & states fever, chills, myalgia, sore throat, cough, flu syndrome, headache, right side facial droop, slurred speech, constipation, urinary retention, difficulty swallowing, weakness, numbness, tingling, decreased reflexes.  Tx w/IVIG, improved slowly & transferred to inpt rehab.  60 Day Follow Up: speech problems have cleared up. Residual right leg weakness. Per annual follow up report-Residual weakness in leg, more fatigue than in past. Has been able to return to driving and working full time.
experiencing headache and chills.; experiencing headache and chills.; This is a spontaneous report received from a contactable consumer (patient herself) via Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 08Feb2021 (Batch/Lot number: Not Provided) as dose number unknown single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine Yesterday (08Feb2021) and now experiencing headache and chills on an unspecified date in Feb2021. Outcome of the events was unknown.  Information about batch/lot number requested.
Missed menstrual period following vaccine. Period was expected April 17 and as of May 7, 2015 has not started. Not due to pregnancy.
full body aches; nausea; headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 09:00 (Lot number: EL3247) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL 3247, administration time: 09:00, vaccine location: Left arm), administration date: 03Feb2021, when the patient was 28 years old, for COVID-19 immunisation, reaction(s): "enlarged lymph node located on top of my clavicle bone that moved independently". The following information was reported: PAIN (non-serious) with onset 25Feb2021 01:00, outcome "recovered", described as "full body aches"; NAUSEA (non-serious) with onset 25Feb2021 01:00, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 25Feb2021 01:00, outcome "recovered", described as "headache".  Additional Information: The vaccine was administered in a workplace clinic. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's other medications in two weeks was birth control. Since vaccination, the patient has not been tested for COVID-19. It was reported that on an unspecified date, the body aches had seized but the nausea continued into the next day and the headache was persistent until "Saturday". The patient reported that the lymph node was still enlarged but feels much smaller and when she had visited her primary care she said it felt to be as big as 1 millimeter.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 4MAR94 & 6MAR94 devel hemolytic anemia w/hemoglobin dec from 11 to 4, WBC count 44,000, platelet count of 525,000 & was jaundiced; hospitalized;
EXCESSIVE BLEEDING; This spontaneous report received from a patient concerned a other, Hispanic or Latino male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included no alcohol, non-smoker, penicillin allergy. The patient experienced drug allergy when treated with clarithromycin for drug used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total dose was administered on 04-JUN-2021 to right arm for prophylactic vaccination. Concomitant medications included Sertraline (100 mg once daily) used for unknown indication. On 04-JUN-2021, the patient experienced excessive bleeding when he tried to cut his nails and scratch his beard but the bleeding did not stop. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excessive bleeding. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210612348-Covid-19 vaccine ad26.cov2.s -excessive bleeding . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient experienced soreness at injection site and fatigue for about 12 hours after vaccination. on 05/18/2021 began experiencing pain at top of shoulder, radiating to front of shoulder, up neck and down to fingertips.
On June 4, 2021 I developed fever, myalgias, Shortness of breath and cough.  A few days later I lost my sense of smell and taste.  I got a COVID PCR test which resulted in a positive result.  Thereupon I quarantined for 2 weeks in accordance with the CDC and my employer.  I also received banvanivimab.  Within 7 days my symptoms were mostly resolved.  I did not require hospitalization or other interventions.
Report arm at injection site right after given.  Pain reported to be continuous, cannot lift arm or lift objects or throw with arm as usual - taking ibuprofen for pain. Slight swelling at site. No redness noted.
Patient received the first dose of the Moderna COVID19 Vaccine on 1/8/21.  He reports he had a sore arm for about 2 days, but soon after developed shortness of breath,  generalized body aches and extreme fatigue, most of which lasted for 6 to 7 days. The shortness of breath worsened during this time and he also developed a bump in the right neck area. Upon admission his oxygen saturation was 91% and he had a 10 L nasal cannula placed, increasing saturation to 93%. As of 1/27/21, oxygen saturation has improved and pt is now on 5 L nasal cannula, saturating at 99%.
inject site devel 4 inch diameter area of erythema & edema lasting 4-5 days; site was hot to touch; no systemic sx;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-APR-2010, at a medical center, the patient was inoculated with ZOSTAVAX, (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JUN-2015, the patient was treated at the medical center (by an unspecified healthcare professional) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acetaminophen and oxycodone hydrochloride (PERCOCET) and oxycodone and acetaminophen for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.
Stuffy sinus especially while trying to sleep.  Raised skin with redness at the area of the shot.  Itchy and hot to the touch.  These reactions started approximately 4 days after receiving the injection and persist to this date.
I woke up in the middle of the night it felt like my back was on fire, like my skin on my back and ankles were on fire. I put some lotion on it and went back to bed. In the morning I had my husband to look at it and he said it looked like a rash. It spread all over my lower back and more so to the left side.  It still has the burning feeling and is itching. I have prescription for hydroxyzine HCL 25 MG that I took at 1pm on the 7th and 1 at 1am today. I did go to Urgent Care I went on 2/7/2021. They said it is an allergic reaction, I saw a PA who said she could not give me a steroid shot  because it she wasn't sure if the steroid shot would counter react with the vaccine. She did prescribe a steroid Prednisone 50 MG one table a day and topical cream Triamcinolone Acetonide 0.1 % cream, she did tell me to check with my primary care doctor or the health department before taking either medication to ensure they were safe to use with the vaccine. PA also make note that my pulse was 130 beats per minute. It did go down some before I left it was 94 beats per minute. My blood pressure was 138/98.  I spoke with the nurse practitioner at my doctor's office today as my doctor is out of town, she said she did not know if I could take the steroid with the vaccine either and referred me to the health department.
During introduction of myself to patient and her husband who both wanted to receive vaccine, patient verbalized anxiousness related to inability to bring mother in with her to receive a vaccine as well. I educated on how they could get the mom an appointment or come to a clinic that we host and patient was then calmed down and relieved that the was more opportunity in future for vaccination. Discussed all registration paper work, V safe paper importance, and EUA form for the Covid 19 vaccination. I then proceeded to vaccinate patient after she verified and verbalized authorization to administer. I then did the same process with husband.  After receiving vaccination, patient was escorted to the observation room for 15 minute waiting period to be monitored for any reactions. After patient sat down with husband who was also vaccination I verified they felt fine and reiterated the importance of notification of any side effects to monitor for, pointed them to the medics in the room and both patient and husband verbalized understanding. A conversation of signing up mom and other family  members to receive vaccine through our notification system online was also talked about for an additional 2-3 minutes and then I said my goodbye, thanked them, and left the observation room.  After leaving the observation room to accept my next vaccine  appointment patients husband notified the EMS medics that his wife, the patient, didn't feel well.   The EMS medics took over and called for an ambulance.
Approximately two to three minutes after receiving the second dose of the vaccine, my face began feeling flush. I also felt a tingling sensation in my face and neck, and I began sweating profusely. I walked up to one of the rescue/paramedic staffers and told them that I had a "flush" feeling in my face. The paramedic asked me a few questions about how I was feeling, then a second paramedic brought a wheelchair. I sat in the wheelchair and was brought to a separate room. The second paramedic noted that I was covered in sweat. The second paramedic and I decided to remove the top layer of my clothing (a polo shirt) because it was drenched in sweat. After about 10 or 15 minutes of sitting in the wheelchair and focusing on my breathing, the tingling/sweating sensation subsided and I was able to walk back into the observation area. I felt a second "wave" of sweating/tingling come over me a few minutes later, but it was minor compared to the first "wave," and did not require additional attention from the paramedics. I did not require any medication during this event.
S:  Patient returns 10 days following MMR injection with complaints of bruising and sore shoulder.  Patient reports that the visible bruising appears to be getting better, but seems to have increased muscle pain especially with movement.  No erythema, focal swelling, purulence, fever, chills, malaise.  O: Right deltoid with large patch of ecchymosis ranging from blue to yellow.  Patient is tender to palpation over deltoid and distal bicep.  Full range of motion with discomfort.  A: Ecchymosis and possible hematoma      Adverse vaccine reaction  P: Likely self limited.  May treat with RICE, NSAIDs, Muscle use.  Return if and new/worsening symptoms.
STATED OCCURED AFTER MIDNIGHT CHILLS. BODY ACHES, TIRED, LOW GRADE FEVER 99.0
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, unspecified number of patients were vaccinated with VARIVAX (Merck) (dose, route and frequency were not reported) which was exposed to 29 F for four months (worst case). No adverse effects were reported. No further information was provided. This case is linked to the case 1404USA007005 and 1404USA007006 (same reporter link). Additional information has been requested.
This medically confirmed spontaneous report (initial receipt 26-Oct-2012) concerns a female patient. On 02-Oct-2012 the patient received AFLURIA (batch number: P58306) injection intramuscularly. After the AFLURIA injection, the patient developed pain in the arm where injection was received. The date the pain started was unspecified. The patient sought medical attention by seeing her pharmacist. No lab diagnostic study was performed. No treatment was given for the event. The event outcome was recovering.
Allergic to the sun. Skin Burns when I go outside during the day. It never did that before
Patient states there has been a color change to her skin around the area of the injection site. It is not red, puffy, swollen, oozing or painful.
The diagnosis of BP was confirmed; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGOID (The diagnosis of BP was confirmed) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Hand eczema.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PEMPHIGOID (The diagnosis of BP was confirmed) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (The diagnosis of BP was confirmed) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: abnormal (abnormal) subepidermal separation and dermal infiltrates with eosinophils. On an unknown date, Blood test: >200/59 (Positive) Positive. On an unknown date, Immunology test: igg/c3/weak (Inconclusive) IgG/C3/ and weak granular IgM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PEMPHIGOID (The diagnosis of BP was confirmed) to be possibly related.    Concomitant medications were not provided by the reporter.  The event was treated with intramuscular corticosteroid(IMCS), intravenous corticosteroid(IVCS), topical corticosteroid(TCS). The event was ongoing  at  day 23.   This case is related to patient 5 which show positive result of hematoxylin and eosin staining.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, more information is required for further assessment. Clarification regarding the seriousness of the event is expected.   This case was linked to MOD-2021-309334, MOD-2021-309420, MOD-2021-309423, MOD-2021-309421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received by safety 09-Sep-2021 included an Email received from a regulatory authority team and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, more information is required for further assessment. Clarification regarding the seriousness of the event is expected.