chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the left side patient's lymph nodes under her arm swelled and became very painful. She also developed bruising under her armpit that extended down her torso.
knocked her out for like 3 days; was in the bed for 3 days; sore arm that is painful; her lips are kind of burned; cold sore keeps popping up inside her mouth; lips tingling; chills; when you move it after each vaccination; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (knocked her out for like 3 days), BEDRIDDEN (was in the bed for 3 days), PAIN IN EXTREMITY (sore arm that is painful), ORAL DISCOMFORT (her lips are kind of burned) and ORAL HERPES (cold sore keeps popping up inside her mouth) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 013M21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN 15 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (knocked her out for like 3 days), BEDRIDDEN (was in the bed for 3 days), PAIN IN EXTREMITY (sore arm that is painful), ORAL DISCOMFORT (her lips are kind of burned), ORAL HERPES (cold sore keeps popping up inside her mouth), PARAESTHESIA ORAL (lips tingling), CHILLS (chills) and VACCINATION SITE PAIN (when you move it after each vaccination). The patient was treated with CAMPHOR, PHENOL (CAMPHO PHENIQUE PAIN RELIEVING ANTISEPTIC GEL) at an unspecified dose and frequency and PARAFFIN (VASELINE LIP THERA) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (knocked her out for like 3 days), PAIN IN EXTREMITY (sore arm that is painful), ORAL DISCOMFORT (her lips are kind of burned), ORAL HERPES (cold sore keeps popping up inside her mouth), PARAESTHESIA ORAL (lips tingling), CHILLS (chills) and VACCINATION SITE PAIN (when you move it after each vaccination) outcome was unknown and BEDRIDDEN (was in the bed for 3 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient used other medication such as gargled with peroxide and water, brushed teeth with ammonia, vitamin b cream, also tried Claritin for allergies and baby aspirin.    This case was linked to MOD-2021-419412, MOD-2021-419718 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow-up received contain no significant information
Mild Tenderness of arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Mild Tenderness of arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TENDERNESS (Mild Tenderness of arm). At the time of the report, TENDERNESS (Mild Tenderness of arm) outcome was unknown.            No concomitant medications reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-037880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Patient's Race information was added
This is an initial spontaneous report from a contactable reporter who was calling from a physicians office. A 1-year-old, female patient (race unknown) received a dose of PREVNAR13 on 29DEC2011. Relevant medical history included cold, coughing and allergy to soy, all since an unknown date. There were no relevant concomitant medications. It was reported that the patient threw-up within 15 minutes of receiving PREVNAR12 on 29DEC2011. The patient had no relevant laboratory data. Therapeutic measures taken in response to the event were none. The consumer had recovered from reported event on 29DEC2011. Follow-up (06FEB2012): Follow-up attempts completed. No further information expected.
2-23-09 Office visit vomiting, diarrhea. 2-24-09 dehydration, vomiting, diarrhea. Hemocult (-) Rota (+), C-diff (+). 10/19/09 Vaccination records received.  bhp 11/10/09 Hospital records received for date 3/18/09 to 3/19/09. Pt seen in ER for fever. Pt seen in office 1 day prior for c/o cough, runny nose, fever, red bulging rt. TM red, swollen uvula in throat, small stye in left eye, diaper rash. Assessment in ER found pt to be dehydrated and pt. was admitted. Pt had 2 episode of vomiting. DX: dehydration, influenza A(+), status post vomiting, Iron deficiency anemia.
Patient resides in the memory department   Patient received 3 doses of the vaccine on 1/7/2021, 2/4/2021, and 3/9/2021.  However,  had indicated in their records that the patient received her first dose on 2/4/2021 and, therefore, arranged for the pharmacy to give the patient a second dose on 3/9/2021, when it was actually her third dose.  was notified of this error and no adverse effects have been reported.
Dysfunctional uterine bleeding, bleeding 38 out of 70 days to include a 25 day period, anemia secondary to acute blood loss, iron deficiency, ended up with an emergency D&C.
DIZZINESS; LIGHT HEADEDNESS; SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.5-101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, sore arm, dizziness and light headedness was not reported. This report was non-serious.
pt to clinic 21MAR97 past 72hr to have area eval lt forearm nl x/for area @ site of administration mod swollen, diffused approx 7cm, pink/red no induration;c/o forearm being very itchy;
pt recvd vax & noted lump @ inj site @ 2pm which began burning & stinging; next few days took off rings on affected arm due to edema; now pt c/o edema in forearm, shoulder & neck pain; unrelieved by apap;called MD ; went to hlth dept;
Leg Swollen, hard to touch, painful with bruising large lesion 5" X 5" sterile abscess.
Erythema warmth pain shoulder 2/3 way to elbow less than 2 hours post vaccination.
Information has been received from a health professional concerning a 10 year old male pt who was vaccinated with a dose of varicella virus vaccine, live. Subsequently, on approximately 04/24/04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up info indicated that "there was no a single report of adverse rxn following varicella vaccination". The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES # 0404USA02615, 0405USA00572,  0405USA00573,  0405USA00574,  0405USA00575,  0405USA00576,  0405USA00577,  0405USA00578,  0405USA00579,  0405USA00580,  0405USA00581, 0405USA00582, 0405USA00583, 0405USA00584, 0405USA00585, 0405USA00586, 0405USA00587, 0405USA00588, 0405USA00589, 0405USA00590, 0405USA00591, 0405USA00592, 0405USA00593, 0405USA00594, 0405USA00595, 0405USA00596, 0405USA00597, 0405USA00598, 0405USA00599, 0405USA00600, 0405USA00601, 0405USA00602, 0405USA00603, 0405USA00604, 0405USA00605, 0405USA00606, 0405USA00607, 0405USA00608, 0405USA00609, 0405USA00610, 0405USA00611, 0405USA00612, 0405USA00613, 0405USA00614, 0405USA00615, 0405USA00616, 0405USA00617, 0405USA00618, and 0405USA006190). No additonal information is expected.
hospitalized 9/17/21 with COVID-19 pneumoniae, immunocompromised with multiple sclerosis on Ocrevus.
Patient admitted to hospital May 8, 2021, with hyperglycemia and confusion, found to have an acute/subacute left PCA stroke. Onset symptoms 3 days previous, tPA not given.  Also treated for UTI.  He was discharged to acute rehab for 2 weeks, then discharged home.
patient felt dizzy and fell off the chair after getting the vaccine.she claimed having blurry vision and being tired. Ambulance being called and her vitals  were checked and all her vitals were normal and she felt better upon drinking water . grandmother refused  to have pt  transferred  to the hospital since she was stable when tthe ambulance arrived. followed up wih the patients grandmother over the phine and hour and she told me that patient was stable and she was just anxoius at the time of vaccine admininstration
A 65 years old women, in the observation area start to feeling itchy in his arms.  Paramedic  take the patient to the attention area and takes the vital; BP; 130/70; HR 88; RR 17 and SO2 96%. Patient refuse to stay more and she takes 2 Benadryl's that she brings to the clinic.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M038846 or lot # M040268. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of six reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005170: US-009507513-1708USA005168: US-009507513-1708USA005169: US-009507513-1708USA005167: US-009507513-1708USA001493.
Patient described having a warm feeling run down vaccination arm and then sweaty hands within 5 minutes of vaccine. Within 15 minutes she said she was feeling itchy. She was given loratadine 10 mg tab and a bottle of cool water. She declined signs and symptoms of anaphylaxis, besides the itching. The itching spread to her trunk and we called EMS, but by the time they arrived patient was feeling better. They assessed her and she declined to be transported to the hospital.
after the first booster had a reaction and did not realize it was that bad; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (after the first booster had a reaction and did not realize it was that bad) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 012A21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure, Arrhythmia and Drug hypersensitivity (Allegra D). Concomitant products included PROPRANOLOL for Arrhythmia, VITAMINS NOS and CALCIUM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (after the first booster had a reaction and did not realize it was that bad). At the time of the report, IMMUNISATION REACTION (after the first booster had a reaction and did not realize it was that bad) outcome was unknown.            Concomitant medications included blood pressure medication. The patient had never been diagnosed or tested positive for COVID-19. There was no medical history related to mentioned and both Acute and Chronic illnesses at the time of vaccination. The patient did not experience similar events in the past. Treatment medication included antibiotics.   This case was linked to MOD-2022-621273 (Patient Link).
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients received improperly stored ROTATEQ (lot # M019706, expiration date 24-OCT-2017, oral: dose was unknown). No adverse effects reported. This is one of two reports received from the same reported. Additional information has been requested.
Fluttering heart - "felt like a butterfly moving across chest"  , chest pain Brain fog  *Pfizer booster - other shots were Moderna
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Aug-2020 and the estimated date of delivery was 27-May-2021. On 03-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 03-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: positive (Positive) positive. On 15-Sep-2020, Ultrasound foetal: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test was 15-Sep-2020. The patient has an established prenatal care. No treatment medications provided by the reporter.
I had an eardrum spasm the afternoon of my first Moderna shot, followed by lingering ear pain and fullness.  I have continued to have ear pain along with my ears popping when swallowing and increased sensitivity to noise. I also experienced intermittent moments of near vertigo that has since improved. The ear pain continues now 2 1/2 weeks later along with ear drum discomfort. My doctor has advised me to begin taking allergy medication despite no history of allergies in the past.
After receiving vaccination the patient waited in waiting area until given the okay to leave. At the front cash registers the patient report heart palpitations and dizziness and was told to sat down. Pharmacist was called up to handle. Patient appeared pale and stated their heart was racing. After some water and sitting for about 15 minutes the patient appeared better and stated she felt better besides some heartburn that she normally experiences. Heart palpitations and racing went away but the patient said she didn't feel normal, possibly dehydrated and anxious due to the event.
3-year-old pediatric patient who received a dose of QUADRACEL intended for children aged 4-6 years with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old pediatric male patient who received a dose of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] intended for children aged 4-6 years with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant (s) and family history were not provided.   On 07-Jun-2023, the patient of age 3 years received a dose of 0.5 ml (1x) dose 4 of suspect Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) vaccine suspension for injection (lot: U7526AA, Expiry date: 07-Sep-2024) via intramuscular route in unknown administration site for immunization which was intended for children aged 4-6 years with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
patient completed Moderna vaccination series on 3/23/2021 and 04/20/2021. Patient presented to Hospital on 6/27/2021 with 3 weeks of increasing SOB, chest pain and confusion. Upon admission, the patient was found to be tachycardic, hypotensive. CT chest angiogram revealed bilateral pulm embolism and ventricular thrombi. MRI brain revealed multiple areas and foci of acute nonhemorrhagic infarction throughout bilateral cerebral hemispheres, suggestive of embolic infarction; largest area of infarction involves right frontal lobe and superior aspect of right insular cortex. Embolic event work up included an ECHO severe decrease in LV function and size ,mildhypertrophy; estimated LVEF is 15%. Cardiologist reviewed the cardiac MRI and patient met criteria for myocarditis. Cardio highly suspects that this myocarditis is due to COVID19 vaccination. Patient is currently receiving IVIG infusion therapy. Patient also on heparin gtt.
3 weeks after receiving ZOSTAVAX, pt noticed a small series of red, itchy bumps that looked like mosquito bites surrounding a larger one with fluid-filled blisters.  She had redness & tenderness at the area.  It took 6 wks to clear.  It was in her left leg, pubic area & R. groin, & back down on her R. tibia.  The ZOSTAVAX injection did not cause pain, swelling, fever or systemic sx's.
Patient presented with swelling of left arm (full arm just not injection site). Patient went to Urgent Care and received prednisone 20mg and Clindamycin 300mg.
After receiving her Moderna IMZ, pt stepped out of both and I was about to administer IMZ to her dad when she suddenly fell over in front of me.  Her mom and I rushed to her aid, fortunately she did not hit her head when she went down.  With her mom's assistance, she walked over to a waiting chair where I suggested pt be sitting on the floor instead of up high on a chair.  I gave patient two ice packs - one for her forehead and one for the back of her neck, and a small bottle of water.  Code white was immediately called, I asked pt and pt's mom and dad if they wanted me to call 911 to have emergency services to check her out, they all declined.  I told them I would be happy to call if they change their mind.  Employees stayed with her and began taking her report.  Patient stayed for about 30 minutes, declined 911 emergency services, and patient left with her parents under her own strength.
pt recv vax 9JAN97 & subsequently, pt devel a rash which consisted of greater than 50 fluid-filled vesicles;
Swollen under the left arm, pain, mild low grade fever, body ache and headaches.  Physical evaluation done in the office 03/21/2022. Vitals: TEmp 98.7, WT: 108 lbs, HT: 55 inches, BP: 134/85, HR 110/ min Pulse ox : 99 % RA.   LEFT axillar : edematous, LAD, 4x 5cm, mild tender, erythematous.  SKIN : few dark spot right leg and left arm.
rash & chest tightness, diarrhea & h/a;given DPH
Information has been received from a medical assistant concerning a patient who on 29-JAN-2007 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot number 655066/1143F), instead of a dose of zoster virus vaccine live (Oka/Merck). The error was reportedly not due to product confusion. There was no adverse experience related to this event. It is unknown if medical attention was sought. The patient's present status was unknown at the time of the report. There was no product quality complaint.
PHARMACY LEFT PFIZER VIALS IN THE FREEZER FOR LONGER THAN 2 WEEKS AT THE TEMPERATURE (-25 AND -15 DEGREES C). WE GAVE DOSES OUT OF THESE VIALS, RENDERING THEM POSSIBLY LESS EFFECTIVE.
2 hours I noticed a taste in my mouth,  that similar to chalk.  I am fine, just did not expect that.  Other than a tender arm all is good.
Pt began having s/s of itching about 1 1/2 hr after injection. This progressed to redness, warmth and whelps at site. All s/s resolved after about 48-72 hrs. Pt had previous injection 5 yrs ago without incident.
#1 Anthrax; redness/soreness at site; equilibrium off (dizzy) for morethan 48 hrs; 10/17 to 10/21 excess fatigue. Blurred vision & redness in R/eye. 10/14, Flu vax, had fever. 10/19, Typhoid vax, soreness at site for 2 days.
Patient reported feeling flushed and shaky 5 minutes after injection, then reported a "weird" feeling in throat that lasted about 2 minutes at around 12 minutes post-injection-Mild
I started getting symptoms of deep cough, chest congestion, extreme tiredness, and malaise. I had a positive COVID-19 home test on 4/26/2022. I also developed a sore throat and runny nose. I called my doctor and I also have a home health nurse and have checked my vital and was advised to rest and to take Mucinex and Tylenol. Most of the symptoms lasted for 3 days except for the sore throat and cough.
Mid morning I started getting chills and took my temperature around 2:00 pm and it was 99.9. I took Ibuprofen and continued to have the chills the rest of the day and the fever did not subside until sometime during the night. I also had a dull headache on Wednesday. I noticed Wednesday morning that my left arm was sore and also my left breast was tender, sore, and had red blotches and continued to be that way all day. Thursday I felt fine.