chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient up to date on Pfizer COVID vaccinations who admitted to the hospital with positive COVID test and complications likely related to COVID.  Provider discharge note below:  "Patient developed increased shortness of breath, admitted with hypoxia though it should be noted that he was recently started on home oxygen @ 2 L/m and the hypoxia was noted on room air.  The hypoxia may be due   to several factors.  He may have had some mild Pneumonia due to COVID-19 virus as he was found to be positive for COVID infection but with diuresis he was saturating well on room air. He had been started on steroids but since he was not truly hypoxic related to the COVID infection and was risk for fluid retention and exacerbation of his heart he was continued on steroids at discharge.    He also has a history of Ischemic dilated cardiomyopathy (EF 20% Echo 12/2021) with AICD (automatic cardioverter/defibrillator) present and may have Acute on chronic systolic (congestive) heart failure though just recently had his diuretic dose increased at last hospitalization.  He was started on intravenous FUROSEMIDE while monitoring  CKD (chronic kidney disease) stage 4, GFR 15-29 ml/min with solitary kidney.  At admission patient noted to have a decreased GFR (21 to 13) likely due to recent increase in TORSEMIDE dose.  Discussed with Dr of cardiology and at discharge his dose was reduced to previous regimen of 10 mg twice daily.      Paroxysmal atrial fibrillation on APIXABAN, AMIODARONE and had cardioversion prior to admission. Note that the patient is nearly eighty and has renal dysfunction and likely should be on the lower dose of 2.5 mg twice daily.     Elevated troponin values with negative delta, no acute findings on electrocardiogram.  No chest pain.  Likely demand phenomena.    Hypertension  Controlled.   Pure hypercholesterolemia ROSUVUSTATIN  Gout ALLOPURINOL  Issues Requiring Follow Up: Recommend follow up basic metabolic panel to monitor renal function.  "
No adverse event.  Booster dose given too early.  Dose 1 Pfizer 09/16/2021; dose 2 Pfizer 10/07/2021
Right arm and leg tingly and numb 2 weeks out. Right hand and foot numb 2 weeks out.  Dizziness, sore arm, neck and back sore immediately after shot.  Joint pain consistent even after 6 weeks.  Ended up getting an MRI of my brain to rule out anything else but it was a vaccine effect.  Started taking medications which lessened the inflammation.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. 01-JUL-2008 and 07-AUG-2013, the patient was vaccinated with dose 1 and dose 2 of M-M-R II (lot#, expiry not reported) 0.5 ml, intramuscularly. On 15-AUG-2013, the patient was vaccinated with dose 3 of M-M-R II (lot#, expiry not reported)0.5 ml, intramuscularly about a week after second dose was administered. The nurse also reported that all three doses of M-M-R II were administered intramuscularly. No adverse effect reported. Follow up report as received from the other health professional refers to a 12 month old male patient (now 6 year and 2 month) with no known allergies. On 07-AUG-2013 the patient was vaccinated with M-M-R II (lot # H013041, exp date: 17-JUL-2014) dose 2, 0.5 ml, subcutaneous in the left leg. On 15-AUG-2013 9:40 AM the patient was vaccinated with M-M-R II (lot # H018945, exp date: 18-OCT-2014) dose 3, 0.5 ml, subcutaneous in the left leg. Concomitant therapies included INFANRIX (lot #25LP9) and IPOL (lot #H1354). The patient didn't require emergency room/doctor visit. Additional information is not expected.
Information has been received on 10/10/02 from a nurse concerning a 13 year old female that was vaccinated with a dose of YF-VAX (lot number UB213AA), IPOL (lot number U10821), and Menomune (UB076AA) on 6/19/02. She developed hives and swelling of the eyelids two hours after vaccination. She was given oral Benadryl by her mother prior to going to the physician's office. She was treated with epinephrine and oxygen at the physician's office. The symptoms resolved per reporter. It was stated by the reporter that the pt, was vaccinated with YF-VAX in the past without incident. Mother denied allergy history. Pt does have sickle cell anemia but is on no medications. It was also reported byt he mother that pt was consuming food prepared by a local vendor when the symptoms developed. Reporter stated, "We are assuming it was the yellow fever vaccine." The cause of the symptoms has not been medically confirmed. Seriousness criteria: other medically significant (OMIC). The follow up received on 7/17/03: New version created in preparation of addendum report (6/1/02-12/31/02): data entry error correction within the system, case is medically confirmed.  A 15-day follow up report received 09/09/2003 adds: From additional info received on 09/02/2003 from the vaccine administrator, it was reported that on 06/19/2002 the pt received her second dose of YF-VAX, administered subcutaneously in the left arm, a second dose of Menomune A/C/Y/W-135, administered subcutaneously in the left arm, and a fifth dose of IPOL, administered subcutaneously in the right arm. The pt info and the reporting physician's info were also updated. Additional info is not anticipated, this case is considered closed.
Customer received a viaccine on 7-8 and it bled a lot. So it was bandaged up and customer went home. The next day right below where the vaccine was injected, customer developed a rash and it kept getting worse. Customer went to her DR and said she had developed an illness caused by the Vaccine.
I had the second booster on Friday and I have been sick ever since; I have a cold; I have had the chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I had the second booster on Friday and I have been sick ever since"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have a cold"; CHILLS (non-serious), outcome "unknown", described as "I have had the chills".  Additional information: it was reported as the patient had a COVID shot (Clarified as Pfizer COVID 19 Vaccine), the second booster shot on Friday (as reported), had been sick ever since. The patient wanted to know how long was that going to last. The patient went to bed Saturday night at 19:00, three blankets were on and had a cold. There was nothing wrong with the patient when going to get the shot, had been sick ever since and how long was it going to last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had congestion and difficulty with breathing, not serious but I noticed a difference. I did have fatigue. In 2022 treated with radiation therapy for prostate cancer. I get Zoladex, for hormone replacement. I am fatigued all of the time anyway.  I tested at home it positive, I called my PCP and was prescribed Paxlovid. It seemed to work very well I felt much better in a couple of days.  I am still fatigue but I do not know which is causing it.
1 of 2 pts who w/in 48 hrs postimmunization exp cellulitis @ the pnu-immune inject site; react included 2cm of induration, erythema & a red horizontal streak in the middle of the inject site; treated w/Amoxicillin x 7 days;
After 7 days my arm became very hot swollen & red. I went to the ER on Sunday 6/11/23 was told I had an allergic reaction to the vaccine. Was told to put ice on it and got a prescription for prednisone. Which cleared it up .
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 13-AUG-2015, the nurse reported that the patient possibly received a dose of improperly stored (Oka/Merck) VARIVAX (dose, frequency and route were unknown), lot# L008272, expiration date 11-MAR-2017. No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 24 year old male patient. In December 2016, the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. The drug was administered to a patient of inappropriate age. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of numbness in a 55-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 8th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced numbness and general body pain. On an unknown date, the outcome of the numbness and general body pain were not reported. It was unknown if the reporter considered the numbness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The nurse reported that the patient who received her 2nd dose of SHINGRIX in left deltoid, has complained of body aches and numbness in her hands feet and chin. The nurse was unable to provide further information of the patient's experience. The reporter gave consent to follow up.
Vaccines: DTP/aP, HepB, Hib, PneumoConjugate, Polio patient had her six month shots at nine months. She was lethargic and feverish the day of and days after. A couple days after shots, she had four runny feces, then started throwing up. For two weeks, she was very fussy. Prior to shots, she was always happy and sleeping most of the night. After shots, she stayed fussy any time she was awake and woke up screaming multiple times each night. One week after shots, she developed a bad rash. When we took her back to the doctor a week after the shots, he said she probably had a virus and dismissed it.  Prior to shots, she had never even had a sniffle. For months, she had a marble size knot at one of the injection sites in her left leg.
Symtoms: Fever, Chills, Nausea, Headache, Difficulty breathing, severe stomach cramps that feel like severe period cramps. This is 2nd day I am experiencing the symptoms and am really concerned
pneumonia; bad breathing; cough; runny nose; hives on chin and eyelid; fever; fatigue; A spontaneous report was received from a consumer who was also a 77-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia, bad breathing, fever, fatigue, cough, runny nose and hives on her chin and eyelid.  The patient's medical history included heart condition and severe asthma. No relevant concomitant medications were reported.  The patient received her first of the two planned doses of mRNA-1273 on 04-FEB-2021 (Batch# 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05-FEB-2021, she experienced bad breathing, fever, fatigue, cough, runny nose and hives on her chin and eyelid. Patient  went to the ER on 10-FEB-2021 where she had a chest X-ray and CAT scan done and pneumonia was diagnosed. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A nurse reported the occurrence of redness at the injection site in a 4-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history included environmental allergies. Other relevant medical history and concurrent conditions were not provided. Concurrent medications included loratadine (Claritin) and fluticasone nasal spray (Flonase). On 10/03/2002 the pt received his 4th injection of Infanrix. On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and influenza virus vaccine (manufacturer unknown). The nurse stated that "immediately" after receiving the injection, the pt developed "slight" redness at the injection site. By 10/06/2002 the injection site redness increased in size to about 10" in diameter with a white center. The nurse stated that "the site had not been painful or feverish." The pt was treated with diphenhydramine with improvement. On 10/07/2002 the pt was seen by the pediatrician who noted that the injection site redness had decreased to about 5" in diameter and there was no hardness, tenderness or cellulitis. The physician recommended cold compresses and diphenhydramine as needed. The event had "almost" resolved on 10/07/2002.
Return of menses after over 1 year of none and hormone levels verified menopause.  Periods began in early August and second period yesterday.
leg aches; chest vibrates; chills; body aches; left knee ached unbelievable; headache; five hours after the shot, couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (five hours after the shot, couldn't eat), PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), HEADACHE (headache) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bypass surgery in 2010.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DECREASED APPETITE (five hours after the shot, couldn't eat) and HEADACHE (headache). On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (left knee ached unbelievable). At the time of the report, DECREASED APPETITE (five hours after the shot, couldn't eat), PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (left knee ached unbelievable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information included Acetaminophen every 6 hours around the clock.   This case was linked to MOD21-058251, US-MODERNATX, INC.-MOD-2021-051962 (E2B Linked Report).; Sender's Comments:  MOD21-058251:Husband case US-MODERNATX, INC.-MOD-2021-051962:wife case
Our son was 1 years old at the time of this vaccine and he was hitting every milestone and a completely normal child, babbling and cooing and starting to talk. After the vaccine, he slept for an entire day and woke up and hasn't talked since. He has been seen by various doctors and specialists and now diagnosed with CAS - childhood apraxia of speech.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2017, the patients were vaccinated with PROQUAD (recombinant human albumin (rHA)) lot # M037012, expiration date 21-FEB-2018, subcutaneously. Concomitant therapies included sterile diluent. On an unknown date in August 2017, the patients experienced incorrect product storage. Additional information has been requested. Sender's Comments: US-009507513-1708USA012836: US-009507513-1708USA012835.
Chills, dizzy, head ache, body aches, hot flashes, nausea.
After receiving the pfiser booster vaccine I was affected with Bell's Palsy on left side of face, started 4 hours after injection, current facial paralysis today - 9 days later and expected to take 3-6 months to heal maybe longer.
It is now 11 days later and the area where the shot was given is red, raised, and painful to the touch.
itching; rash and blotchy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (Pfizer-Biotech COVID-19 Vaccine), via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 19Feb2021. Three days ago (01Mar2021), she started itching under where you bend your neck and then this progressed bigger and became very itchy and formed into a rash and blotchy. It was on the front of her neck and went down to the upper chest a bit. She would like to know if this is a delayed reaction and if she should receive the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 64-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805426 was crossed linked to original case 201804863 due to same reporter.
Client got very quiet and lost eye focus immediately after vaccination. She reported feeling dizzy around 2 minutes after vaccination. After reclining client, they lost consciousness about 9 minutes after vaccination for 3 minutes. EMS was activated, upon regaining consciousness, clients mental status was still altered per staff report. Client was then transported via EMS to local ER.
PATIENT RETURNED FROM TRIP ON 9/4. PATIENT GOT VACCINATED ON 9/5. ON 9/6 PATIENT STARTED EXPERIENCING FEVER/CHILLS/TINGLY SKIN AND ABOUT A DOZEN "SPOTS" ON HIS HEAD, CHEST, BACK, LEGS AND SHOULDERS. SPOTS WERE NOT PAINFUL OR ITCHY. SOME LOOKED HIVE-ISH, OTHERS LOOKED LIKE PIMPLES WITH A HEAD. THE PERSON HE WENT ON TRIP WITH GOT A RASH AROUND HIS ANKLE. PATIENT DID NOT TAKE ANYTHING. FEVER/CHILLS RESOLVED AFTER A COUPLE OF DAYS AND RASH RESOLVED BY THE END OF THE MONTH.
pt seen by MD 3JUL96 p/reporting 3 red raised bumps near inj site of 2nd Hep B vax given 29JUN96 @  5PM;
2 days before testing positive for COVID-19 I had a slight sore throat while I was on vacation. On July 26th I got up from bed and was nauseated, fatigue, and had a splitting headache. I went to a hospital because it was that bad. The gave me antibodies and they tested my blood. They said I had a dangerously low sodium level and sent me to a bigger hospital in a ambulance. The next day they tested me for COVID-19 and I tested positive. I just started to feel better 2 weeks ago
Pt voiced metallic taste in mouth and lips tingling.  Voiced initial compliant @ 1350.  Left observation @ 1415, denies any s/s of distress not trouble w/ SOB or breathing.
arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little sore). At the time of the report, PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment details were provided. Follow-up received on 04-JUN-2021 included no new information   This case was linked to MOD-2021-029198, MOD-2021-029198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Possible NNI
Child developed fever to 105.2 (temporal) and headache the day following vaccine administration.
After I got the vaccine, I was really tired more than normal. I didn't feel good at all. I had a headache off and on. Then starting on 4/12/2022, I woke up and I was really lightheaded and dizzy. I felt like I was drunk. I didn't know what to think. My blood pressure was fine when I checked it. I started getting nauseas from the dizziness to the point where I threw up. I took Zofran to stop throwing up. The dizziness continued. I took it easy the rest of the day. The next day I was dizzier and it was worse. I had ordered groceries to be delivered to my home, and I wasn't even able to pick up my groceries because I felt weak. I felt like something was pushing down on my head. That night I had chest pains. On 4/14/2022 I was still having chest pains so I took some Nitro medication, and then the chest pain went away. I called the doctor and they never got back to me. Then I called my family doctor and he told me to call the emergency number because when I checked my blood pressure it was higher than normal. The ambulance came and took me to the hospital. The ER thought I was having a heart attack because they said that my troponin levels in my blood was high, but they actually mixed up my blood work with someone else's results. So, then it was said that I wasn't having a heart attack. The doctor's said that since I been sick with bronchitis the infection could have traveled to my ear which could cause the dizziness. I was at the hospital for 1 night. My blood pressure went up to 185 or 187 over 103. Then it went down to 175 over something. The doctor said I could go home, but I still had a high blood pressure reading so I didn't feel comfortable going home. I'm back home and sometimes my blood pressure reads up to 140 over something. I was prescribed meclizine 12.5mg 3xday up to 10 days as needed for dizziness. I have a home nurse who is going to monitor my blood pressure.