chrisvoncsefalvay/vaers-outcomes huggingface dataset:
May of 2010, CBC plt were normal. Dec of 2010, WBC count of 2.5 - hemoglobin = 7.0 - plt = 14 - no schistocystes or RBC fragments to suggest consumptive coagulopathy, no teardrop cells, plts appear nl, INR = 1.29. Patient complaining of melanic stools, abdominal pain, nauseam decreased appetite, for since December 20, 2010.
Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 2nd of 4 reports.   A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients
No adverse event; Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. The patient was administered vaccine booster dose with a volume of 0.25 ml (25 mcg) instead of 0.5 ml (50 mcg).  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was not provided.
A few minutes after I had difficulty swallowing, heart was pounding and dizziness.  Symptoms got better after sitting and waiting 20 minutes.  That night into the next day I had a fever, aches and chills, nausea, headache and fatigue.  Once that passed I had three days(Tuesday-Thursday) of random moments of heart palpitations.  I also had some minor headaches and some fatigue.  On Thursday 4/29 I went to  doctors care after having heart palpitations a couple of hours apart in the morning.  They said everything seemed fine and to rest.  On 4/30 and 5/1 I was slightly fatigued and had a tightness in my chest.  On 5/2 and 5/3 I only had some fatigue and a headache. I went to a primary care doctor 5/4. My blood pressure was slightly on the high side.  Other than that everything seemed fine.  I also had some dizziness in the afternoon that day.  Each day seems a little better but still just working through the symptoms.  Before the vaccine on 4/25 I was feeling very well and I have never had any heart palpitations in the past.  I am 5'4 130lbs and a overall very healthy person.
multiple episodes of paranoid state, over whelming fear,  extreme anxiety, negative thoughts not my normal, night terrors', bad dreams, violent dreams. scared to go to sleep, nausea, tingling , paranoia, still have anxiety with fear of another episode can last for long  periods at a  time.  The longest time with out an episode has been 5  days.
No adverse events - RN inadvertently administered .25 mg Flu vaccine. Client should have received .5 mg Flu vaccine.
Child developed fever between 102 and 103 fahrenheit, orally beginning that evening and lasting on and off for 5 days.  It is thought that the etiology was an infection in his foot that coincided with the same date of his flu immunization, but there was no lab work done at that time to support this.  In fact, there was some symptom related to foot weakness/pain PRIOR to the administration of the flu vaccine.
sore arm; tired; headache; nausea; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:45 at the age of 51-years-old (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. The patient was not pregnant.  No Covid prior vaccination. The patient had not tested for Covid post vaccination. Medical history included bicuspid aortic valve, thyroidectomy, seasonal allergy. The patient concomitant medications were not reported. The patient experienced sore arm, tired, headache, nausea all on 10Mar2021 14:00 with outcome of recovering. The patient did not receive any treatment for the events.  The events were assessed as non-serious.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with lot # (669631/0156AA) an unspecified dose of M-M-R II on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was administered a dose of MMRII that had been exposed to 5 temperature excursions to a high temperature of 55 degrees Fahrenheit for an unsupportable cumulative total of 8.5 hours (Excursion dates 27-JUL-2012 for 1.5 hours; 08-SEP-2012 for 3 hours; 09-SEP-2012 for 4 hours). No adverse effect was reported. No treatment information was reported. No further information is available. This case is linked to case MARRS # 1211USA012758, 1212USA000924 and 1212USA000925 (same reporter). Additional information is not expected.
Immediately Patient got her shot, she fainted.  Patient laid on the floor immediately with both legs elevated, she gained consciousness right away and was able to state her name and DOB, etc. Vital signs within normal limit-122/78, 99% 02 on room air, 94 HR, 18 RR, 98.Temp. Pt was monitored for 30mins, she feels fine other than slight headache, mom was instructed to give Patient Tylenol as prescribed for age-she verbalized understanding. Mom and Patient was also educated on possible side effect of vaccine, how to treat side effect and when to call 911-They both verbalize understanding
The next day after receiving the vaccine, I felt extreme fatigue which lasted about two weeks. I have had the same reaction to each COVID-19 vaccine. I take medication that causes fatigue, but this was completely different. I had difficulty completing my daily work because I was so tired. I take water therapy twice a week that has helped with fatigue. I also had an impaired memory for a few days too. Each day that passes, I do feel better.
Injection site pain; Body Ache; Tiredness/Exhaustion feeling; This is a spontaneous report from a contactable consumer (patient).  A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266), via an unspecified route of administration in right arm on 17Feb2021 at 08:30 pm as single dose for COVID-19 immunization. The patient medical history included hypertension, blood cholesterol and overweight. There were no known allergies to patient. there was no COVID prior vaccination. The concomitant medications included metoprolol, simvastatin and amlodipine. On 18Feb2021, the patient experienced injection site pain, body ache, tiredness/exhaustion feeling. Patient did not receive any treatment for adverse event. There was no COVID tested post vaccination. It was reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 10Mar2021 at 08:15 am as single dose for COVID -19 immunization. The outcome of the events was not recovered.  No follow-up attempts possible. No furthermore information expected.
This woman had her first Moderna Covid 19 vaccine on 3-2-21 around 9:30am.  Nothing significant or different occurred in this woman's day after her vaccine.  Her husband had to wake her up for an appointment around 7:00am, which is unusual for her.  She usually wakes on her own around 6:00am.  She was moderately confused, unable to dress herself, or care for herself to get ready for the day or her appointment.  She did not remember that she had an appointment for an MRI this morning.  Her MRI appointment was scheduled for 9:30am and he did take her for that appiontment.  He was not allowed to go back with her.  He did call Dr. office.  She is out of the office and they referred her to the Clinic.  He stated he would not take her there.  I referred him to take her to the Emergency room, which is just down the hall from where she was having her MRI.  He isn't sure how well she will do without him and she is not able to care for herself or understand basic instructions to undress, lie down, etc.  He stated that he will likely take her to the Emergency room since her doctor is not available to see her.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that 1 third dose was given to an immunocompromised patient out of 3 patient.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-370372, MOD-2021-371249, MOD-2021-371275, MOD-2021-371244, MOD-2021-371280, MOD-2021-371284 (Patient Link).
my second dose and the hives came back immediately; my histamine levels were critically high; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (my second dose and the hives came back immediately) and HISTAMINE LEVEL INCREASED (my histamine levels were critically high) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (my second dose and the hives came back immediately) and HISTAMINE LEVEL INCREASED (my histamine levels were critically high). The patient was treated with PREDNISOLONE at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of In the morning and LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at a dose of At night. At the time of the report, URTICARIA (my second dose and the hives came back immediately) and HISTAMINE LEVEL INCREASED (my histamine levels were critically high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: critically high (High) Blood test came back negative for everything on allergies except my histamine levels were critically high..         No concomitant drugs were reported.   This case was linked to MOD-2022-461933 (Patient Link).
Roughly 11 days after receiving my booster shot I began to experience a burning itch all over my body, my body broke out into hives. These symptoms have lasted for four days now, and they are more manageable, but I still have red marks in various places on my body and itching
fever; hot; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, 1 days after receiving Shingrix, the patient experienced fever and feeling hot. On an unknown date, the outcome of the fever and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the fever and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 16th July 2019, in the morning at 9:30 am, the patient felt hot and took temperature and it was 99. Two hours later, the patient again took temperature and it was 99.4. The patient did not consent to follow up. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Urticaria onset occurred 12 hours post vax. Prescribed antihistamine and cortisone for 5 days.
Sore arm beginning one hour after injection. Subsided after three whole days. Sore arm resumed a week after injection along with apperance of a lump under the skin at injection site plus additional two smaller lumps next to injection site.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 27-Mar-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: inconclusive (Inconclusive) 20 week pregnant. On an unknown date, Ultrasound scan: inconclusive (Inconclusive) 20 week pregnant.     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.   Patient was taking pre natal vitamins. No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
RINGING EARS, RIGHT SIDE WENT NUMB, PASSED OUT, HIT HEAD HAS CONCUSSION
Discharge Physician: MD, MPH Primary Care Physician: MD  Date of Admission: 3/24/2023 Discharge Date: 3/26/2023 Room Number:  PRESENTING PROBLEM: GI bleed [K92.2] Gastrointestinal hemorrhage with melena [K92.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 68 y.o. female who presents today with GI bleeding.  She has a history of DM, fatty liver disease for which she previously saw Dr., HTN, PAD, COPD, Bipolar disorder, and adrenal mass s/p removal.     In the ER today she tested positive for COVID.  Hemoccult was positive.  BUN mildly elevated at 26 with creatinine of 0.82.  Initial glucose was 49.  WBC 6.76, hgb 12.0, platelets 275, lactic acid 0.9, UA negative for infection.  CXR showed cardiac enlargement with small right pleural effusion.  CT of the abdomen/pelvis showed possible very mild colitis and possible mild cystitis.  However, CTA abdomen and pelvis thought wall thickening was likely related to underdistention.  She was given dextrose for hypoglycemia.  She was given IV protonix, zofran, and IVF.  She was placed in observation for GI bleeding. GI consulted and  recommended PPI q12 and advancing diet as tolerated. Stool studies were negative. Outpatient EGD/colonoscopy was recommended due to COVID19 status. She received IV iron infusion and ASA/Plavix held, given no further bleeding. ASA/Plavix resumed without further bleeding noted.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. . Patient voiced understanding was agreeable with plan of care discharge
Right arm, right side, right lower back started hurting and swelling the day the shot was administeted.  After 24 hours, fever began.  Right lymph node under my arm began to swell.  72 hours later the swelling in the lymph node amd arm was so bad I couldn't put my arm down.  Still had a low grade fever.
Sudden onset of calls and fever. Abated over a course of 4-5 hours.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of ligament laxity in a male newborn exposed to BOOSTRIX (GlaxoSmithKline) taken by the mother during pregnancy. The mother of the subject's medical history included one previous pregnancy resulting in normal birth of a full-term infant. On 4 October 2011 the mother of the subject received a dose of BOOSTRIX (.5 ml, intramuscular, unknown site). The baby experienced maternal vaccine exposure during the third trimester of the pregnancy. The mother was approximately 29 weeks gestation at the time of vaccination. The conception was reported as normal. The mother's date of last menstrual period was 17 February 2011 and her estimated date of delivery was 15 December 2011. Unspecified prenatal testing had revealed no evidence of a defect. Follow-up information was received on 28 February 2012. The mother's conception was reported to be normal. Concurrent medication taken by the mother included FLUVIRIN (starting at 29 weeks), Ranitidine (starting at 29 weeks), Prenatal Plus Vitamins (starting at 20 weeks), Acetaminophen (starting at 20 weeks), FLAGYL (starting at 29 weeks) and Amoxicillin (starting at 10 6/7 weeks). The mother of the subject had a history of one, normal vaginal delivery. There was no relevant, maternal, family medical history. No maternal history of alcohol or tobacco use. There was no relevant, paternal, family medical history including no illnesses, no birth defects (genetic or chromosomal disorders), no substance abuse and no vaccinations. It was reported that the male neonate was delivered on 21 December 2011, at 40 weeks gestation via normal vaginal delivery. The neonate weighed 8 pounds and 7 ounces. APGAR scores at 1 and 5 minutes following birth were 09 and 09 respectively. A defect of left foot ligament laxity, inverted, but easily reducing to midline was reported. The event was reported to be mild (not serious) and it was noted that the condition would be monitored. Not reported to have been related to vaccination. Mother case linked, A0948554A.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 83-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Cancer (NOS) (survivor). Concurrent medical conditions included Type 2 diabetes mellitus.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact
Acute urticaria after receiving injectable quadrivalent flu shot. No relief with OTC med or prednisone taper. Duration currently 3 wks.
I believe the shot was improperly administered too close to my shoulder joint, and as a result, I have experienced increasing pain over the last 11 days.  Initially, there was mild pain (I would rate a 3-4 out of 10) near the injection site immediately which persisted for days as expected after getting a shot; mainly discomfort during sleep and when moving my arm. Pain has become progressively worse, and not better as reported to be a normal and expected side effect. At day 10 I called my PCP to go in for an exam. She ordered an Xray and prescribed muscle relaxers. Xray showed no signs of breakage (as expected).  Today is day 11 and  I can barely move or lift my arm without severe discomfort, I would rate the pain as severe (9 out of 10) when moving or lifting my arm, rotating shoulder, sleeping on it.  While I have not been diagnosed with anything in particular yet, I believe I have a shoulder injury relating to improper vaccine administration (SIRVA). I have requested to be referred to a shoulder specialist for evaluation. I have not had prior injuries or symptoms in this area. I am an active and healthy person with no known health conditions and this is very troubling. I am a strong advocate for COVID vaccines, yet, I must say this experience has me questioning my decision to get one.  I never knew this could happen, and I sincerely hope my shoulder is not permanently impacted by this event.
3/31/2022 12:52 resident states feels tired and weak, moist productive cough, decreased appetite, hoarse voice,  O2 sats 96%RA a febrile  3/31/2022 23:00 mouth breathing and using accessory muscles, lungs decreased scattered rhonchi, O2 sats 80%, placed on simple face mask, skin hot and dry to touch VS 100.3,69,24,140/75, O2 up to 97 with simple face mask @6L, Tylenol given for temp. 4/1/2022 no PO intake 4/2/2022 resident suctioned for large amount of yellow mucus. 4/3/2022 lungs remain decreased with scattered rhonchi, skin pale and warm to touch. 4/4/2022 resident alert and talkative, recognizes staff, skin warm and dry, moist NP cough resident stated he is feeling better. 4/5/2022 Hospice consult  4/6/22 PO medications dc'd as resident is unable to swallow. 4/7/22 0940 resident non responsive to verbal stimuli, skin warm and dry, no restlessness, no oral intake, no mottling noted.  4/7/2022 20:25 resident restless tachypnea at 36 4/7/2022 22:10.