chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was given 3 immunizations while in for her physical on Friday 2/11/11. Developed flu symptoms, low grade elevated temp, & chills, left arm pain & swelling on 2/12/11 Sat. Went to medical center where she was started on KEFLEX 500mg PO BID x 7 days and BENADRYL 12.5 mg/5ml elixir 25mg po prn. Returned to clinic on 2/14/11- LA arm feeling better, still quite swollen. Returned began to cinic 2/16/11 Lt arm still swollen & having pain, increased KEFLEX to qid. Recommend f/u in 2 days - no f/u appt occurred.
Initial unsolicited report received from a consumer on 08 December 2015. This case involves a 48-years old male patient who was vaccinated with a dose of Flu (batch number, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On 07 December 2015, following the vaccination, the patient had shivers. Laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the event (felling great). List of documents held by sender: none.
got COVID after his first shot of the vaccine; got COVID after his first shot of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02101783.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID after his first shot of the vaccine". The patient underwent the following laboratory tests Reporter was a consumer called on behalf of his dad who took the PFIZER vaccine for COVID 19. Reporter stated that his dad got COVID after his first shot of the vaccine, and before receiving the second shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
DESCRIBED BY PATIENT AS SWELLING IN ENTIRE UPPER LEFT ARM, WITH HEAT AND PAIN AT AN 8 ON SCALE OF 1-10 (10 BEING HIGHEST); LASTED 4 DAYS; NO REDNESS  PATIENT TOOK BENADRYL AND TYLENOL
Received a Tetnus vaccine on 11/6/2017 at Hospital Urgent Care. Immediately had shoulder discomfort-the next day and following days I was unable to lift my arm and had extreme discomfort. The pain moved from my shoulder into my fore arm and down into my hand. One week and  a day later I went back to Urgent Care - the nurse practicioner prescribed me Predisone- I had some relief while on the predisone but the pain returned after I finished the prescription. The following week I went to Urgent care to Medical Center- the nurse practicioner there gave me another round of Predisone this time at a higher dosage. Again, the pain was slightly relieved but did not subside. the following week I tried an orthopedic DR again who suggested no kind of treatment for my pain except physical therapy. 4 weeks later I have pain/constant aching in the shoulder continuously that is worse at night when I try to lay down. Cramping/nerve pain down into my forearm muscle and right hand/thumb. Still unable to lift small things with my right arm. The initial nurse who gave me the shot placed it not quite one finger length down from my shoulder.
Shortly after receiving the first dose of the primary series of the Moderna COVID-19 vaccine, the patient started feeling lightheaded and dizzy. While checking his blood pressure, the patient became unconscious and started convulsing. Pharmacist laid patient on the ground. After 30-60 seconds, patient regained consciousness. Pharmacy technician called 911. EMS took over care of patient at this point. EMS transported patient to a local Hospital Emergency Dept.   Three hours later patient returned for his COVID vaccination card and stated that he was back to normal.
Induration, erythema (in a circular pattern around injection site), pain: all at injection site.
On January 26th said she was seeing double images one and above the other. The next day she seen her doctor for this matter.
acute renal failure; again he lost control of his legs in the middle of the night; elevated CPK; pretty bad chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACUTE KIDNEY INJURY (acute renal failure), LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) and BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ALLOPURINOL for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) (seriousness criteria hospitalization and disability) and CHILLS (pretty bad chills). On 08-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (acute renal failure) (seriousness criteria hospitalization and medically significant) and BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) (seriousness criterion medically significant). The patient was hospitalized from 08-Apr-2021 to 11-Apr-2021 due to ACUTE KIDNEY INJURY and LOSS OF CONTROL OF LEGS. On 11-Apr-2021, ACUTE KIDNEY INJURY (acute renal failure) outcome was unknown, BLOOD CREATINE PHOSPHOKINASE INCREASED (elevated CPK) had resolved. At the time of the report, LOSS OF CONTROL OF LEGS (again he lost control of his legs in the middle of the night) and CHILLS (pretty bad chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood creatine phosphokinase: 22,000 High. On 10-Apr-2021, Blood creatine phosphokinase: 10,000 High. On 11-Apr-2021, Blood creatine phosphokinase: 6,412 High.   Acute renal failure was due to something in the vaccine that attacked the muscles in his legs.   IV saline was given as a treatment  HCP appointment is on the 19/apr/2021  Company Comment  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.   This case was linked to MOD-2021-080270 (E2B Linked Report).; Sender's Comments:  MOD-2021-080270:first dose
NO ADVERSE EVENT EXPERIENCED BY PATIENT, BUT VACCINE VIAL HAD BEEN PUNCTURED 20 HOURS PRIOR TO VACCINE AND KEPT IN REFRIGERATOR
Patient's arm turned red and painful in the area beneath where the shot was administered. The red area was several inches wide when she presented to the pharmacy.
Excruciating pain shooting down same arm as injection site. The pain lasted between 8 to 10 hours. Ibuprofen would not help the pain.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patient was vaccinated with either GARDASIL or GARDASIL 9, intramuscularly (lot#, expiration date, dose and route were not reported). The patient passed out in the physician's office after receiving the vaccine. The outcome of the event was not reported. Causality assessment was not provided. Additional information is not expected as there was no consent to contact the reporter.
Pain in the  back of the head extending down the right ear and down to the right jaw . Feel like the pain in traveled down a vein. Pain hasn't subsided, it varies in degrees. Severe at times, could put teeth together.  October 13th, pain was as severe as it was on day one, which was very severe. Tylonol and Aleve were taken. Helped but not much.
Pfizer-BioNTech COVID-19 Vaccine EUA: After vaccination, the vaccine recipient had a syncopal episode. They were observed by EMS. No further intervention required.
Fever, chills, body aches and pain at the injection.  Treatment is Tylenol. Patient will continue to monitor
Started with body aches and chills about 10 hours after the vaccine. Woke up the next morning , felt dizzy. Went to the bathroom and when I stood up, I passed out, causing me to hit my head and cut my head.
chest is being really hard; short of breath; Right side of my face is getting kind of swollen; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for covid-19 immunisation and had no adverse event. The patient stated, 'I' took the second vaccine today (on 29Apr2021) and I am a little like (voice feeble nor clarified further), I am not sure if its fine, but 'I' feel like my chest is being really hard and I am kind of short of breath, also the right side of my face is getting kind of swollen. So, I am not sure what should 'I' do, if it starts like a normal effect. The patient stated, 'I' just want to make sure that I am fine. The outcome for events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Noted redness and swelling (R) upper thigh on 9/26 am, no pain, no irritability. Given Tylenol because felt warm but temp not checked. (R) thigh 2 1/2 cm area erythema with 1 1/2 cm central induration.
This spontaneous report as received from healthcare worker via company representative, refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot # and dose not reported). On an unknown date the patient experienced "a single episode of fainting" after vaccination. The outcome of fainting and relatedness between fainting and GARDASIL were not reported. This is one of several report received from the same source. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 11/30/2022 Discharge Date: Dec 6, 2022 COVID positive date: 11/30/2022 PRESENTING PROBLEM: Severe sepsis (HCC)  Pneumonia due to organism    HOSPITAL COURSE: Patient is a 70-year-old female with PMH significant for CVA (02/2015) with right-sided weakness, type 2 diabetes, gastroparesis, neuropathy, GERD, dyslipidemia, chronic lower back pain, dysphagia, major depression, vascular dementia (patient is a long-term resident and has a guardian presents to the hospital 11/30 due to AMS, dyspnea and a COVID diagnosed about 9 days prior to presentation.  Patient had been slowly deteriorating, was noted to be hypoxic in the facility and was put on oxygen and was also noted to have decreased oral intake and decreased responsiveness.   In ER she was febrile 38.6, tachycardic 139, tachypneic 25 and hypoxic she was also lethargic and not very communicative.  Patient was started on broad-spectrum antibiotics Zosyn/vancomycin, imaging studies CT T/A/P showing-- bilateral airspace disease/pneumonia right greater than left, leukocytosis 14, BUN 36, creatinine 2, lactic acid 4.6 and procalcitonin 0.31.  COVID test was positive.  She was also noted to have a urinary tract infection.  Patient had 1 bilious emesis and needed nasopharyngeal suctioning in ER. EKG without ST-T changes and patient admitted for severe sepsis.   Patient admitted for severe sepsis related to pneumonia.  Aspiration was suspected, SLP evaluated and resumed dysphagia diet.  Dysphagia/aspiration precautions should continue. Zosyn/vancomycin was subsequently transitioned over to Rocephin/doxycycline to finish 5-6 day course.  Symptomatically improved.  Patient was able to wean down to room air.   There was a suspected urinary tract infection at the time of presentation, cultures growing Proteus and Pseudomonas, however urinalysis itself was not impressive and urinary tract infection was felt to be ruled out. Patient subsequently had watery profuse diarrhea, C difficile was negative, was felt to be related to opioid withdrawal.  Patient was noted  to be on fentanyl patch chronically but not initially validated at admit and hence was not continued.  This was resumed at half dosage at 25 mcg.   Patient was noted to have low-grade vaginal bleeding, pelvic ultrasound showed endometrial thickening, requested following up with Gynecology as outpatient.   I assumed care for the patient on day of discharge (12/6) - she felt well with improved breathing and denied any concerns including no difficulty with swallowing, chest pain, dyspnea, N/V, or abdominal pain. Pt had transport set up at 9:30 am per my colleague. Patient's glucose level was uptitrated.   She is discharged in stable condition.
This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received BOOSTRIX (batch number 7537X, expiry date 15th February 2015). On 12th November 2014, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: BOOSTRIX administered to a 4 years old as the 5th DTP vaccine, instead of intended KINRIX.
pt recv vax 9SEP96 & devel a high fever up to 104, sweating & extreme weakness;pt to MD to have a sinus infect;MD assumed fever d/t sinus infect;
A cyst has increased at least 5 times in size since receiving second dose; Cyst became sensitive; Painful to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 17Jul2021 at 09:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke in 2012, high blood pressure (HBP) and high cholesterol. The patient had sulfonamide allergy and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received nifedipine (MANUFACTURER UNKNOWN) and experienced drug allergy.  On 19Jul2021, the patient experienced a cyst which increased at least 5 times in size since receiving second dose of vaccine. Cyst became sensitive and was sometimes painful to the touch. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cyst which increased at least 5 times in size, cyst became sensitive and painful to touch were not resolved at the time of report.
Pain and soreness at injection site.  Body aches and headaches.  Fever at 100.8  Fatigue.
Legs and calves were hurting real bad; Soreness in his legs and calves; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs and calves were hurting real bad) and MYALGIA (Soreness in his legs and calves) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21N) for COVID-19 vaccination.     Concurrent medical conditions included Pain, Blood pressure and Cholesterol. Concomitant products included LISINOPRIL for Blood pressure, PRAVASTATIN for Cholesterol, TEMAZEPAM for an unknown indication.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Legs and calves were hurting real bad) and MYALGIA (Soreness in his legs and calves). At the time of the report, PAIN IN EXTREMITY (Legs and calves were hurting real bad) and MYALGIA (Soreness in his legs and calves) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional concomitant medication include pain medication.   This case was linked to MOD-2021-294323 (Patient Link).
underage vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage vaccination) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported.
Information has been received from a health professional concerning an 64 year old white female with IVP dye allergy who on Nov 08 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649694/0386P), in the left deltoid. There was no illness at the time of vaccination. Subsequently, On Nov 09 2004, the patient experienced pain, redness and swelling at the injection site, The patient was treated with rest, moist heat and cephalexin (Keflex) (x 7 days). Subsequently, the patient recovered after 72 to 96 hours. There were no relevant diagnostic tests or laboratory data performed. It was noted that the patient and the patients sibling did not experience and adverse symptoms following prior vaccination. It was noted that four other patients had a similar reaction (WAES0502USA00745, WAES0503USA00536, WAES0503USA00537, WAES0503USA00540). No further information is available.
Information has been received from a registered nurse concerning an 8-year-old male with no known drug allergies who on 31-JUL-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 25-FEB-2004 at 09:15 am, the patient experienced an outbreak of blisters on his face, head, chest , legs and arms; some are crusted. No medical attention was sought. The patient's mom treated with calamine lotion and Benadryl. Subsequently, the patient recovered from the outbreak. Additional information has been requested.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022; Vaccine administered to patient past its 30 day expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 4:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medication was reported. On 01-Apr-2022, the patient received the booster dose of the vaccine. No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
I had to have a mammogram in between the two doses. Right before the 2nd dose, because of the lymph nodes I got after the 1st vaccine. I got a breast biopsy after the 2nd dose, so it wasn't malignant. There is still pain in my breast, still can't lift. I healed but I still have a scar.
I just wanted to report that I awoke at 11 p.m. and had severe chills, fever, shaking, feet were ice cold. Later developed a severe headache with nausea, vomiting. Took the weekend to recover and gain energy back. The first injection I had in January I developed severe tiredness that lasted for a week, but my reaction to the vaccine for the second shot was very severe and felt I needed to report it.
I am bruising *very* easily, with just moderate pressure against my skin (arms, legs, hands, feet, torso).; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 59-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 04Jun2021 11:00 (Batch/Lot Number: EW0171) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 59 years). Facility type vaccine: Pharmacy or Drug Store. The patient past medical history included osteoarthritis from an unknown date and unknown if ongoing and Acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included naproxen (NAPROXEN, 5 days prior) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE, daily) taken for an unspecified indication, start and stop date were not reported.  The patient previously took tetanus toxoid and experienced drug hypersensitivity and bnt162b2 dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 10:30 am (Batch/Lot Number: EW0179) as DOSE 2, SINGLE for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 05Jun2021, The patient experienced bruising very easily, with just moderate pressure against my skin (arms, legs, hands, feet, torso). No treatment was received. The event outcome was not recovered.  Follow-up attempts are completed. No further information is expected