chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching/tingling neck, cheeks, mouth, tongue, lips. Took 50 mg Diphenhydramine, 600 mg ibuprofen. Swelling in neck and shoulder with large fluid-like bulges including down left side of ribs. Hives at injection site. Lasted about 4 days Fever over 102 degrees Fahrenheit for 42 hours. Lethargy, exhaustion, feeling of fogginess in thinking, dizziness lasting for first 3 days, then lessened but continued for about 15 days with periods of overall not feeling well for total of 4 months.
Patient received a second Pfizer COVID-19 bivalent vaccination on 11/25/2023. Her first Pfizer COVID-19 Bivalent vaccination was received on 10/04/2023.  No adverse symptoms reported. This adverse event was incidentally discovered  during  review of staff time related to COVID-19.
Developed large area of erythema and induration of right thigh within 24 hours of receiving DTaP #5.
pt went to Health Center on 6/8/19 @ around 10:30 Am. pt was c/o red swollen Left arm. pt deltoid was red and swollen area measure 13cm x 15cm. pt was dx with cellulitis and treated with Keflex 250 /5mL - 8ml bid for 10 days. Doing much better Red & swollen gone  No fever.
This case was reported by a pharmacist and described the occurrence of flu like symptoms in a 56-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Co-suspect vaccination included FLUCELVAX (Novartis, unknown). On 5 January 2014 at at approximately 13:00-14:00, the subject received a dose of BOOSTRIX (.5 ml, unknown) and FLUCELVAX (non-GSK); Novartis. On 5 January 2014 at approximately 19:00-20:00, 6 hours after vaccination with BOOSTRIX and FLUCELVAX, the subject experienced flu like symptoms, nausea, vomiting, fever and chills. A pharmacist reported a subject had flu like symptoms following BOOSTRIX and FLUCELVAX vaccinations. The pharmacist did not specifically mention the flu vaccine as a possible cause for the symptoms, it was only named as a concomitant vaccination. The pharmacist considered the events were disabling. At the time of reporting the flu like symptoms, nausea, vomiting, fever and chills were unresolved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX.
sore arm, sore neck, ha, no fever, blister @ inject site seen by MD;
resident received TB injection on 1/26/21 and 2/4/21 and it was discovered that she received her COVID 19 vaccine on 1/20/21 so she should not have been eligible for the TB injection. No adverse reactions have been noted.
Severe reoccuring mouth sores, still present tingling and numbness in extremities, subsided. Migraines and tinnitus, still present. Tremors (external), subsided increased heart rate. Subsided fatigue and weakness throughout body, still present
Received the vaccine in the morning (Wednesday). While a sore arm developed throughout the day about 12 hours later started getting severe chills. Was awake all night alternating between freezing chills and a hot fever. Extreme body aches and could not get comfortable. Felt extremely  bad the entire next day (Thursday) with the same symptoms and could not work but towards the evening symptoms subsided. That following day (Friday) I felt better but started getting a headache before bed and that night after going to bed woke up at 2am with a migraine. Worst headache of my life. Felt so bad thought I was going to throw up. Pain subsided with Tylenol. Went back to bed and woke up the next morning nauseous (Saturday). Felt very nauseous through the morning and in the afternoon evening it was less extreme but still present. Felt fine when I woke up the next day (Sunday).
Chills and cold sweats from  8pm to 8am. Fever reached 100.9 for at least five hours. 24 hrs later running 99.8. The most worrisome side effect was loosing consciousness while sitting on the toilet.
Initial unsolicited report received from a pharmacist (patient's mother) on 03-Nov-2017. This case involves a 10-month-old male patient who was vaccinated with a 0.5 ml first single dose of FLUZONE QIV (batch number, expiration date, site of administration were not reported) intramuscularly on 31-Oct-2017. Patient's medical history was not reported. Concomitant medications were not reported. It was also reported that he had not received any other vaccines. On 01-Nov-2017, one day following the vaccination, the patient was irritable. On 02-Nov-2017, two days after the vaccination, he experienced an elevated temperature to 102.8 degree Fahrenheit and broke out in a rash. It was also a case of actual medication error due to overdose Other laboratory investigations was not reported. The patient did not receive any corrective treatment at this time. The outcome of the events was reported as not recovered. Follow-up information received from a pharmacist (patient's mother) in the United States on 28-Dec-2017. This patient was vaccinated with a 0.25 ml first single dose of FLUZONE QIV (Batch number: UT5897JA) intramuscularly in left thigh on 31-Oct-2017. The patient's immunization history included first, second and third doses of PEDIARIX on 17-Feb-2017, 19-Apr-2017 and 20-Jun-2017 respectively. First dose of VAQTA on 20-Dec-2017, first dose of HEPATITIS B VACCINE on 15-Dec-2016, first and second dose of PEDVAXHIB on 17-Feb-2017 and 19-Apr-2017, first and second dose of  FLUZONE IIV4 P-FREE on 31-OCT-2017 and 06-DEC-2017, first dose of MMR II on 20-DEC-2017, first, second, third and fourth doses of PREVENAR 13 on 17-Feb-2017, 19-Apr-2017, 20-Jun-2017 and on 20-Dec-2017 respectively and first and second dose of ROTATEQ on 17-FEB-2017 and 19-APR-2017. The event of medication error (overdose) was removed as the patient received correct dose of flu vaccine. On 03 Nov 2017, one day post following vaccination, mother called office reported fever and rash on arms. He also had runny nose due to possible viral illness. No distress noted. It was unsure if the patient was seen by medical staff. Mom was advised if he worsened she may give DIPHENHYDRAMINE HYDROCHLORIDE (Benadryl). Patient was in care of grandparent at the time. The patient was recovered from the events. He received a second dose of Fluzone 0.25 mL on 06-Dec-2017 without any incident. List of documents held by sender: none.
Received Menactra vaccine 8/22/2007. Presented at student health on 9/18/07 with c/o muscle pain and intermittent tingling in extremeties.  Symptoms persisted but unchanged during visits of 9/19/07, 9/20/07 and 9/21/07.  Called and c/o weakness in legs and difficulty swallowing on 9/24/07.  Sent to ER-released same day- dx with neck sprain.  Presented to student health services again on 9/25/07 with increased weakness, changes in neuro exam.  Admitted to hospital the same day.  Diagnosed with Guillain- Barre.  Remains hospitalized and undergoing treatment currently.    11/19/2007 D/C Summary received for DOS 9/25-10/01/2007 with D/C DX: Guillain-Barre syndrome. Pt presented with 10 day hx of lower extremity weakness. Neurology and ID consults done. Started on IVIG.  Steady but gradual improvement in strength.  D/c with home PT and OT  Per 60 day follow up: Continues with PT/OT on an outpatient basis.
A few hours (5) after the vaccine i had a very sore arm that lasted 3 days. The next day after receiving the vaccine I had a strong headache. The headache was pounding. It started Saturday morning and lasted till Monday night. I took Tylenol as much as I could but it didn't help. I also had chills on Saturday and Sunday. My head felt warm Sunday.  By Monday night I felt back to normal.
This spontaneous report as received from a other health professional refers to a 20 years old male patient with immunization. The patient was vaccinated with lot # (1291AA) dose 1, .5 ml GARDASIL on 26-SEP-2011. No other co-suspects were reported. Concomitant medications included: VYVANSE. On 29-NOV-2012 the patient experienced hives, 431 days after onset of therapy. Treated with ZYRTEC. The relatedness for hives is unknown for GARDASIL. He received the first injection 9/26/2011 there were no adverse effects reported. The second injection was received 12/29/2011, after which he developed mild hives and did not report it to his healthcare provider. He received his third dose 11/28/2012 and two days after developed hives all over his body and was seen in the office for treatment. Additional information has been requested.
Inconsolable; very fussy, swollen abdomen, decreased appetite. Onset x 1-2 days.
Dizziness, Fever, NauseaVomiting, fatigue, flushed face Narrative:
Thiis spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions, drug reactions or allergies was provided. On unspecified dates, the unspecified number of patients received two improperly stored doses of oral, ROTATEQ one dose with lot # L008578 and expiration date 14-DEC-2016 and one dose with lot # L008034 and expiration date 05-AUG-2016, route defaulted to oral (dose was not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported a large, X-shaped bruise in the right arm post-vaccination, that was present for at least 3 weeks, and slowly resolving.
A company representative reported that a female received an injection of flu vax in 1993 and subsequently developed hives. She recovered. No further information was available at the date of this report.
A few days after the vaccine my lymph nodes in my upper cervical area high in my neck area swollen which caused me to have a sore throat. A single small ulcerative lesion appeared in the upper soft palate of my mouth so I went to a walk in clinic and had a strep done which was negative. D/t the ulcers appearing in my mouth I had and HIV test done which also came back negative. I had a small low grade fever and muscle aches also associated but the lesion in my mouth is what caused the major concern which slowly resolved over the next few weeks.
Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy  (started within 6 hours and continued for 6 weeks (and on-going)
Moderna vaccine given on 09/02/2021 and the expiration date was 08/31/2021
After 15 minutes of receiving injection, I had a panic attack. I felt as if I was going to pass out. So Informed the pharmacist she had me put my legs up, wasn?t helping. So i laid on the floor and put my legs on a chair. My body felt extremely hot, my husband said I lost coloring in my face. After about 30 minutes, I was able to get up and walk to my car with assistance. I had chills for 2 days. I am still having issues with anxiety attacks and consulted with my nurse practitioner.  We are monitoring at home and if I feel I can?t manage, she will call in a prescription for me.
I tested positive for COVID-19 on 01/13/2023. It felt like a cold. My symptoms were mucus, dry horse cough, shortness of breath. I called the on-call provider and told him I tested positive for COVID. We then did a telehealth visit and the provider and he prescribed PAXLOVID. I took PAXLOVID for 5 days and then I tested negative. I did have a heart valve back in 11/05/2004. Serial #25NO4F1252 Model#FR99525. I just get regular check up but did want to add that in here. I do have an echo every year. My last Echo I had damage in my valve.
INCREASED BLOOD PRESSURE; ANXIETY; LOOSE BOWEL MOVEMENTS; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroidectomy, and concurrent conditions included milk allergy, and the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with cephalosporin nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced anxiety, loose bowel movements, increased blood pressure. She said that her normal blood pressure was 120-130/ 68 mm of Hg. On the day of report, her blood pressure after receiving the vaccine was 161/84, although this was after eating.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, loose bowel movements, and increased blood pressure. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and anxiety, loose bowel movements, and increased blood pressure as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210343165-Covid-19 vaccine ad26.cov2.s -Increased blood pressure. This event is considered unassessable. The event 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.
I had a fullness in my sinuses, mild headache, and it lasted for 10 days before I went to see the physician. The physician prescribed antibiotics and told me if I was not better within 2 weeks he would prescribed a second dose of antibiotics. I had to call for a second dose of antibiotics and have not had any other symptoms.
Spiked a 105 degree fever, broke out in full measles rash, sent to hospital after unable to lower fever.
Left thigh swollen and red from toe up above hip,Lasted 2 1/2 hours - resolved with Ice and Bath
mother holding child asleep-felt child jerking, slobbering, "glassy eyes" @ 10 am; approx 10pm had another sz;
No adverse event; Patient realized that they gave the same Bivalent vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7171B and 052D22A) for COVID-19 prophylaxis.   Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Primary monovalent dose, Lot 013L20A & Exp. Date: unknown) on 21-Jan-2021, Moderna COVID-19 Vaccine (2nd Primary monovalent dose, Lot 030M20A & Exp. Date: unknown) on 17-Feb-2021, Moderna COVID-19 Vaccine (First Monovalent Booster dose, Lot 019F21A & Exp. Date unknown) on 26-Oct-2021, Moderna COVID-19 Vaccine (2nd Monovalent Booster dose and Lot 048L21A& Exp. Date: unknown) on 13-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 26-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Jan-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine).    No concomitant medications were reported.  Patient told that usually get vaccinated at the local Health Department. Today patient went to a doctor's office and did not have vaccination card with her. When patient came home, realized that they gave the same Bivalent vaccine. Patient feels fine and did not have any side effects.  No treatment information was provided.
SORE THROAT; SWOLLEN TONGUE; This spontaneous report received from a patient concerned an adult of an unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. On unspecified dates, the patient previously received 2 doses of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown), frequency time 01 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The patient had no adverse events following covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, (dose number in series 2), frequency time 01 in total administered on unspecified date for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for severe to moderate rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, following covid-19 vaccine ad26.cov2.s (dose number in series 2) the patient experienced sore throat, and swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, and swollen tongue. This report was non-serious.
Pt felt dizzy approximately 5 min after vaccine went outside for fresh air. Apparently fainted and tumbled down 2 stairs. Observed in clinic for abotu 30 min. Recovered.
cough, runny nose (painful urination), fell this morning getting out of bed. starting 1/18/2022
Throughout the day, January 8, 2021, I found myself short of breath and my joints were painful more that usual. My resting heartrate went from 62 to 71-73. I felt lightly dizzy and certainly weaker than usual.  I had a headache much of the day and when I got home, I immediately went to bed I was so tired. I slept for over 10 hours but did not feel refreshed.
Fever, felt very sick the evening after my vaccine  then developed Covid 19 five days later still with 102 fever and terrible coughing.
This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number expiry date not reported), via an unspecified route of administration in left arm on 05Feb2021 00:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood pressure abnormal and chronic kidney disease. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram, diltiazem, amlodipine, calcitriol and iron. The patient experienced cold sweat, slight fever and chills (all non-serious) on 06Feb2021 03:00, no treatment. The outcome of events was unknown. Information on the lot/batch number has been requested.
The patient is a 66 y.o. female with past history of diabetes, GERD and HTN who presents to the Emergency Department with visual changes of the right eye and associated pain to the face and neck. Per interpretor, patient woke up feeling at baseline yesterday morning, when she had her COVID-19 vaccine. Yesterday around dinner time, she began having issues with vision in her right eye, causing her visual field in that eye to appear dark to her entire right eye. She told her husband that she thought she might have a hair or eyelash in her right eye and that she had an irritating pain radiating from her right eye to the right side of her face. Even after washing her eye with cold water, the sensation did not subside. At approximately 3-4 AM this morning, she also began to experience pain to the back of her head and neck bilaterally. This morning, the visual impairment improved from the entire visual field to now only just the inferior aspect of the right eye. However, she denies weakness to any of her extremities. Patient also denies chest pain, numbness, abdominal pain or nausea. She was seen at ophthalmology, at which Dr. diagnosed her with a right retinal branch arterial occlusion and decided to send her to SHE to be evaluated for the possibility of a CVA. She denies being on blood thinners or taking Aspirin. She denies any previous diagnosis of a CVA or TIA.
Face turned bright red and extremely hot for 1 1/2 days, I was extremely nauseous and very fatigued for over a week.
Patient returned to pharmacy 2 days after injection, with red and warm area around right arm injection site.  I recommended her to see a physician.  Patient reported that they thinks this is minor celluitis or an allergic reation.  Patient was placed on Keflex 500mg 1tid x 10days.
Positive covid-19 test result; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid-19 test result) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse effect.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid-19 test result). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid-19 test result) 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.   no treatment details were provided
Pt received vaccine was instructed to wait the required time. Within 10 minutes patient stated her throat was starting to close. He friend alerted the medical staff and was immediately taken to our emergency room. Vitals taken, examined by physician, epi pen 0.3mg given. Within few minutes patient stated she was feeling better and could swallow. Pt was monitored for 30 minutes and rechecked by physician and released home.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a first grade female pt who on 04/22/99 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed chickenpox. Unspecified medical attention was sought. A prodsuct quality complaint was not involved. Follow-up information was recevied from the registered nurse who indicated that the patient was not vaccinated at her facility. Chickenpox was diagnosed on or about 17-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience. (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02113, 0403USA02114, 0403USA02115).