chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of dizziness and numbness of her upper lip after the first dose of Pfizer. Patient verbalized she felt better after the intervention and she went home. BP 162/80; HR 80
Developed muscle aches, fatigue, congestion and cough on 5/4/2022. Started having difficulty breathing on 5/6/2022 and maintained previous symptoms. Went to the Emergency Department regarding breathing and was prescribed prednisone 20mg 2x daily. Breathing problems returned after completing prednisone. Felt fatigued, short of breath and had cough through day 10 after developing symptoms.
It was reported that a pt (1 of 5) received a Fluzone SV '00-'01 vaccination. Reportedly, sometime after the vaccination, the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.
FIRST HOSPITALIZATION:  On 12/15/2022, patient presented to the emergency department for evaluation of dizziness, falls, and lower abdominal pain. She was given a COVID-19 NAA test and had a positive result; Her chest x-ray showed some atelectasis and subacute left sixth and seventh rib fractures; CT of head was normal. Patient was diagnosed with acute cystitis without hematuria, acute kidney injury, COVID-19, dizziness, frequent falls. She was treated with IV Rocephin and admitted to the hospital for further evaluation and treatment.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital. SECOND HOSPITALIZATION:  On 12/22/2022, patient presented to the emergency department for evaluation of diarrhea, lightheadedness, nausea, and weakness. She was previously diagnosed with COVID-19 on 12/15/2022 when she was hospitalized for urinary tract infection; She was discharged on Ceftin which she stopped 12/21/2022 due to diarrhea. Patient reported 3 days of diarrhea and abdominal pain so a CT abdomen pelvis without contrast was ordered; There was no CT evidence of a clear cause for the patient?s symptoms. Patient was diagnosed with acute kidney injury, diarrhea of unspecified type, dehydration, COVID-19. She was admitted to the hospital for further evaluation and treatment. The patient died on 1/1/2023 while an inpatient at the hospital. Her death abstract listed immediate cause of death as bradycardia due to lactic acidosis, pneumatosis intestinalis, and COVID-19 infection; with other significant conditions listed to be failure to thrive, hypertensive urgency, and hyponatremia.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital.
Swelling and redness at the injection site that was around 1 1/2  inches in diameter, warm to the touch, felt itchy and painful at times ; we treated it with ibuprofen and a cold compress/freezer pack
No adverse effect reported; inadvertently administered a dose of PNEUMOVAX 23 on 5/18/2019, that was expired; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 18-MAY-2019, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# N027629, expiry date: 11-MAY-2019) for prophylaxis (expired product administered). No adverse effects reported. Product quality complaint not involved.
temperature excursion; was administered after this excursion; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Lot number: HG4589, Expiration Date: 31Dec2024) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 2023, outcome "unknown", described as "temperature excursion"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 2023, outcome "unknown", described as "was administered after this excursion".  Additional information: Had an excursion and is not sure when it happened. She was just going back to when they were last there, which was Friday evening. The last temperature they did on Friday was 8 degrees Celsius. On Monday morning, the place was hot. The temperature in the building was hot. They did a refrigerator temperature and the display showed 7 degrees Celsius. However, the high and low is what was different: High temperature was 10 degrees Celsius, Low temperature was 4 degrees Celsius. Time out of range: Assuming, since the staff was not there for the weekend, about 64 hours. Seeking viability information.  Clarifies only the Comirnaty was administered after this excursion. She had no patient information at time of call.
Systemic: Chills-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FAINTING- NO LOSS OF CONSCIOUSNESS-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE, PATIENT STATED SHE WAS LIGHT HEADED. THEN PROGRESSED TO NAUSEA AND PLACED HEAD BETWEEN LEGS SAYING SHE FELT HOT. ICE PACKS WERE PLACED ON PATIENTS NECK. SHE SAID SHE NEEDED TO LAY DOWN AND TRIED TO TAKE HER TO MINUTE CLINIC BUT SHE WAS PLACED ON FLOOR BECAUSE SHE WAS UNSTABLE WALKING. SHE LOST CONTROL OF HER BOWELS AND HAD DIARRHEA ON HERSELF AND THE FLOOR. 911 WAS CALLED AND VITALS WERE TAKEN AND SHE WAS STABLE. SHE REFUSED TO GO TO ER BECAUSE SHE SAID SHE WAS BETTER.
pt recv vax 30OCT97 & 11DEC97 lab eval revealed a lack of seroconversion (0.49);
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000819: US-009507513-2112USA000820: US-009507513-2112USA000817: US-009507513-2112USA000713: US-009507513-2112USA000818: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825.
Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both eyes are bright red; both eyes are bright red, watering, and aching; both eyes are bright red, watering, and aching; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 23:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 07Jan2021 at 14:00 (at the age of 46-years-old) in the left arm for COVID-19 immunisation. The patient reported that on 18Feb2021 she experienced injection site soreness, fatigue, severe headache and now (as of 21Feb2021) eye trouble. She had been feeling pressure behind her eyes and now (at of 21Feb2021) both eyes were bright red, watering, and aching. She didn't know if she would need to have her eyes treated. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The clinical outcomes of feeling pressure behind her eyes/eye trouble, injection site soreness, fatigue, severe headache, both eyes are bright red, watering and aching were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Immediate pain felt upon injection where I exclaimed to the Nurse that it hurt very much. Few hours later severe pain at injection site and severe swollen-ness. Pain and numbness has continued from top of shoulder (rotary cup) down to the left elbow. The area is hurts when touched (to-date from 11/14). Range of motion is limiting and painful when trying to raise arm up overhead especially while dressing. Arm is numb when first waking up. Upper arm hurts after long days at work from typing on computer.  Today, Dec 7th - Pain now has moved to upper shoulder near left neck area and below slightly above the shoulder blade and is tight and painful to touch. I spoke to my Doctor on Monday, 12/5 and He advised to take ibuf  I spoke with my Doctor on Monday, 12/5 and he advised I should take Ibuprofen up to 800 mg for the pain. I have a follow up Doctor Appointment (first available) on Thursday, Dec 15th.
Given 2-21-14 - Developed pain at injection site as expected then over next weeks - fever, chills, fatigue and weakness.
Edema, pruritis, redness and warm to the touch extending from injection site to approximately six inches down the arm
at about 3AM I had became flushed,  I had chills for several hours,  my Oxygen dropped to about 88Spo I used my Cpap  which helped bump up my Oxygen up to 90 to 93Spo.  my fervor toped out about 100.9  Saturday night,  when I woke up. on Sunday my fervor was gone I started to feel normal,
Information has been received from a pharmacist referring to a female patient of unknown age. There was no medical history or drug reaction/allergies reported. On 11-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L032184 with expired date 25-NOV-2016, dose and route were unknown). No concomitant therapy was reported. Within 3 days after vaccination, in May 2016, the patient experienced "tingling in one side of her trunk and bumps". The pharmacist stated the patient sought medical attention on 19-MAY-2016 at a clinic and was prescribed by an unspecified provider acyclovir 8000mg three times a day for treatment. The pharmacist was requesting a lot check for the ZOSTAVAX (lot# L032184). The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
I started feeling pain at the injection site around 8pm the same day I got the injection.  I went to bed and woke up around 2am with extreme pain.  My right arm was swollen and red where the injection was placed.  The rash was raised and hard to the touch.  I've had the flu vaccine for many years and have never had a reaction like this.
Narrative: Patient received first COVID vaccine at outside clinic and felt sleepy post-vaccination. Med response was call and patient was taken to ED with signs of hypotension, confusion, and bradycardia. Patient did not eat food prior to vaccine which may have contributed to symptoms. Upon assessment, it was decided that patient should be able to tolerate next dose but must make sure he has  good oral intake.
Patient had local swelling and cellulitis. Patient seen in ER 2 days afterwards and treated with clindamycin. Symptoms have improved. No other reported symptoms.
DIARRHEA; HEADACHE; MUSCLE ACHES; FEVER; PERIOD CYCLE  STARTED 3 HOURS AFTER GETTING THE SHOT; DROWSINESS; BODY CHILLS; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was not reported and height was 67 inches. The patient's concurrent conditions included: penicillin allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-OCT-2021, the patient experienced period cycle started 3 hours after getting the shot. On 15-OCT-2021, the patient experienced drowsiness. On 15-OCT-2021, the patient experienced body chills. On 15-OCT-2021, the patient experienced headache. On 15-OCT-2021, the patient experienced muscle aches. On 15-OCT-2021, the patient experienced fever. On 22-OCT-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: bismuth subsalicylate, and loperamide hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from drowsiness, body chills, headache, muscle aches, and fever on 19-OCT-2021, had not recovered from diarrhea, and the outcome of period cycle started 3 hours after getting the shot was not reported. This report was non-serious.
Left arm swelling 1-27-16. Axilla swelling started 1-28-16. Chest wall tender/firm starting 1-29-16.
SkinRash Narrative:  For 3 days after #2 dose had rash on upper arms and abdomen thighs face. Saw urgent care provider, prescribed prednisone taper for 3 days and rash has cleared. Denies lip tounge swelling or throat tightening.
Pain in arm that wasn't there after injection or anytime before, painful to move arm, tiredness and weakness, headaches, shakiness immediately after vaccine, lingering pain in arm-hurts to touch the place where vaccine was administered.
Info has been received from an RN concerning a 22 month old white female with a history of conjunctivitis and no drug allergies who on 6/11/04 was vaccinated, SC in the left thigh, with 0.5 ml 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant vaccinations included a 1st dose of MMRII live administered, SC in the right thigh and a 3rd dose of poliovirus vaccine inactivated, administered IM, in the left thigh. There was no other concomitant medication. The child presented to the physician's office on 3/29/05, with a diagnosis of gastroenteritis, and a rash on her stomach, which was breakthrough chickenpox. No fever or itchiness was noted. No treatment was required. Unspecified medication attention was sought. There was no product quality complaint. The outcome was report as recovering. There were no laboratory diagnostic studies performed. There were no adverse events following prior vaccination of the pt or sibling. Follow-up info received from a nurse indicated that she was unable to locate the report of breakthrough. Additional follow-up info indicated that the pt had breakthrough chickenpox of approximated 10 lesions on  her upper chest and back and 3/29/05. It was diagnosed by clinical exam in the office. No additional info is expected.
Inch and a half of erythema spreading on the deltoid area; Some adenopathy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy).   At the time of the report, INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy) 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 information was provided. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI - Reporter denied further contact.
pt recvd vax; inc t then sore throat; swollen neck glands; mucousy eyes began 10nov94; to er; started  ceclor,rash began on 11nov94; ceclor DC'd possible allergic rxn to ceclor & or vax;
Immediately had sinus tachycardia and brought to the emergency room. Developed bilateral neuropathy and left sided numbness afterwards. Imaging and lumbar puncture ultimately performed which showed multiple sclerosis. I had no symptoms prior to being vaccinated with the COVID19 vaccine.
Pt complained of nausea/dizziness after 5 min at post-vaccination area. We gave her an icebag for her  neck and she was on the floor for the next 20 minutes for observation.  Checked her BP twice-- 143/119 then 143/110.  Pt was also on blood pressure meds.  Pt also stated that she has not had anything to eat in the morning prior to the vaccine and that she felt a bit nervous about her second dose Moderna.  We gave her some crackers and made sure she was ok before leavin
pregnant; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PREGNANCY (pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A2-A and 017B2-A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-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 an unknown date and the estimated date of delivery was 16-Sep-2021. On an unknown date, the patient experienced PREGNANCY (pregnant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PREGNANCY (pregnant) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
CHILLS, BODY ACHES, FEELLING HOT BUT NOT FEVER ,HEADACHER
Was given MCV4 vaccine on 2/2/15 to left deltoid. Developed swelling, redness, induration to site today at approx. 10 AM.
Pt. called me (9/26/15)-stated was very tired, got chills, felt like every joint in her body ache. Pt stated she might go into walk-in clinic. Pt was mad!
11NOV93 in evening fever 104 R up for 8 hrs screaming unconsolably at 48 hrs post immmun pt was fine;
p/vax pt exp inj arm feeling very heavy; 1wk later pt had pain in the wrist of inj arm; within several wks arm became very inflamed; swollen; red; & painful; tx: ibuprofen; lymerix was not discontinued; symptoms improving
BLEEDING; MULTIPLE SURGERIES; BLOOD CLOT IN THE LEFT LEG; This spontaneous report received from a patient concerned a 63 year female. The patient's height, and weight were not reported. The patient's past medical history included: surgery, and concurrent conditions included:  drug allergy (erythromycin, Ultram), non-alcohol user, and non-smoker, and patient did not use illicit drug or drug abuse. Patient took a lot of medications but nothing for the blood clot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAY-2021 on right arm for prophylactic vaccination. Age at time of vaccination 63 years old. No concomitant medications were reported.  Two days after vaccination on 21-MAY-2021, patient had surgery on left leg and then had the blood clot. Patient ended up on Heparin for a long time. Patient was in hospital for long time and had 4 surgeries and was at high risk and in wheelchair. Patient had the surgery started bleeding and had to do another surgery and rehab , and was on heparin for long time and went to the hospital for many times, after she left the hospital on 27-JUL-2021 started weening down on Heparin and went home. Patient had initial surgery on 7-MAY-2021 and another on 21-MAY-2021 then on 16-JUN-2021 and 15-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in the left leg, and the outcome of multiple surgeries and bleeding was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220520075-Covid-19 vaccine ad26.cov2.s-Blood clot in the left leg, Multiple surgeries. 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). Therefore, this event(s) is considered unassessable. V0:20220520075-Covid-19 vaccine ad26.cov2.s Bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS(HEPARIN). Therefore, this event(s) is considered not related.
pt states that when she woke up next day after taking vax she was extremely tired, felt like she has diarrhea (but did not actually have it), chills, and shaking.  Her left arm is hurting from the injection site to her neck and down to her elbow.  Pt says her BP is 126/71. Heart rate 96. Temp 102.0.  Pt has not taking any meds other than her BP and Thyroid meds.  Pt has not contacted her PCP at this time.
all over body aches; headache; generally feeling unwell; all over body aches; headache; generally feeling unwell; all over body aches; headache; generally feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient).     A 35-years-old (non-pregnant) female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 16Feb2021 13:30 as DOSE 2, SINGLE for covid-19 immunization (age at vaccination 35 years). The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL 3247), via an unspecified route of administration, administered in Arm Right on 26Jan2021 14:00 as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced all over body aches, headache and generally feeling unwell on 17Feb2021 11:00. Patient did not received treatment for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Severe chronic headache that went on for weeks.  I have occasional migraines, but this was different.  Much worse than a migraine and continued for 3-4 weeks.  It also involved vomiting during the headaches, (normally I don't vomit during my migraines).  I tried taking sumatriptopan (my migraine meds) but it didn't work- headache continued everyday.  Finally had appointment with my primary care.  She put me on daily preventative medicine- propanalol 10 mg per day and it helped.  I am still on daily propanalol to prevent the headaches (and I never needed daily meds prior to the vaccine).