chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 98yo male pt died at home on 11/19/2021. PMH: Vitamin D Deficiency (SCT 34713006) SBD- Seborrheic dermatitis (SCT 50563003) Allergic Rhinitis (SCT 61582004) Atrial fibrillation and flutter (SCT 195080001) Pulmonary emphysema (SCT 87433001) Supraventricular tachycardia (SCT 6456007) Serum vitamin B12 low (SCT 165645009) Constipation (SCT 14760008) Diabetes mellitus (SCT 73211009) Seen by palliative care service (SCT 441874000) Congestive heart failure (SCT 42343007) Routine General Medical Examination at a Health Care Facility (ICD-9-CM V70.0) Common bile duct calculus (SCT 307132003Anemia (SCT 27137000) Low back pain (SCT 279039007) Carcinoma of lung (448993007) Sciatica (ICD-9-CM 724.3) Abnormal findings on diagnostic imaging of lung (SCT 274533004) Edema (ICD-9-CM 782.3) Hypertonicity of the Bladder (ICD-9-CM 596.51) Hypertrophy (Benign) of Prostate with UrBenign essential hypertension (SCT 1201005) Hyperlipidemia (SCT 55822004) Arthritis (SCT 3723001) Pt had received covid vaccines on 1/8/21 & 2/5/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Information has been received from a registered pharmacist for a nurse concerning a one day old female who on 10/16/02 was vaccinated with a 5UG dose of hep B vaccine recombinant. On 10/16/02 the nurse noted blood in the "hub" of the needle after injecting the vaccine. She was concerned that she may have nicked the pt's vein and some may have been administered IV. It was also noted that the pt had a "bleb" on her skin that was not there previously. It was also noted that there was no hypersensitivity reaction apparent. Unspecified medical attention was sought. No additional info was available.
groin pain; thigh pain first one side and then the other; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (groin pain) and PAIN IN EXTREMITY (thigh pain first one side and then the other) 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 20-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (groin pain) and PAIN IN EXTREMITY (thigh pain first one side and then the other). At the time of the report, GROIN PAIN (groin pain) and PAIN IN EXTREMITY (thigh pain first one side and then the other) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  Treatment medication was not provided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: an earlier negative test; Positive, notes: Positive COVID-19 test after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information:  Positive COVID-19 test after completing Paxlovid treatment and an earlier negative test.
Rash developed on upper (R) arm from elbow to shoulder. Red and itchy. Slightly warm to touch. Developed day after vaccine.
It started with the usual pain in the arm that turned into severe chill. I had a really high fever of about 104.0 and everything was tasting different for me for about a week after the vaccine. Foods tasted like other foods, and I felt really lightheaded. I still have that quite often. My blood pressure is reading really low. While having blood work done, my blood pressure dropped extremely low around 90/60 and I passed out. They were not able to get any blood from me. They used ice packs and smelling salts to get me to come back to. I have been working from home since Monday due to this as I do out while having blood work done related to something else. They are afraid to get blood work from me and they are considering stopping the hydrochlorothiazide as they think it could be related to this. I am scheduling an appointment with a cardiologist. There were nights that I thought about going to the ER because the high fever did not break until after 6 days and the taste started to return after 7 or 8 days.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 06-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Patient is a 69-year-old female history of hypertension, diabetes, hyperlipidemia and COPD who presented to the ED on 1/2 with shortness of breath, cough, vomiting and diarrhea.  On arrival, patient was hypoxic requiring 3 L nasal cannula and was hypertensive in the 140s.  Lab work was significant for hypokalemia with 2.4, hypomagnesemia of 0.8 and COVID positivity with otherwise unremarkable vitals.  Urinalysis consistent with UTI.  CTA of the chest was performed and negative for PE or other acute process but did show findings suggestive of pulmonary hypertension and COPD.  Patient was started on antibiotics, breathing treatments and electrolyte replacement with admission to the hospital. The following AM, 1/3, patient was started on decadron given her oxygen requirement and COVID positive status. Over the next 36 hours, patients Potassium and phosphors were replaced multiple times. She was able to be weaned off oxygen and was stable on room air on 1/4. Given ongoing hypokalemia, patient received multiple oral doses throughout the day 1/4.  Ultimately, patient was hemodynamically stable on room air with improving electrolytes and discharged home on 1/4.  She was provided a prescription for Decadron to complete a course for her hypoxia with COVID.  She was also provided a prescription for 20 mill equivalents of potassium daily to take for the next 5 days and a prescription for BMP in 7 days and was encouraged to follow-up with her PCP following her lab test.  Lastly, antibiotic for UTI was not prescribed on discharge. I called multiple times with no answer so a voicemail was left instructing the patient to pick up Keflex from her pharmacy. She will only require one more day to complete course for simple cystitis; urine cx pending           Discharge diagnosis   Acute hypoxic respiratory failure, resolved COPD exacerbation COVID-pneumonia Urinary tract infection, urine cx pending on discharge Nausea, vomiting and diarrhea, stool pcr negative  Hypomagnesemia Hypokalemia Hypophosphatemia Hypertension Diabetes
It was a fever that got to be 102.0. I also had fatigue, but I did not know if that was from the chemo. I had cough and congestion as well as a fever. I completed a COVID-19 PCR test in the emergency room. I was given ringers lactate for hydration, and they decided that I could not get the PAXLOVID due to chemo. The hydration really helped and then it was just a matter of taking MOTRIN. I really noticed a difference after getting the IV. The fever broke and started going away. It took about 3 days to test negative. I still felt tired and fatigued but that may have been due to chemo. I went in for my annual mammogram in September of 2022 also following the 3rd dose of the COVID-19 vaccine. There was an abnormality seen so I had to go back in for an ultrasound. It showed cancer in breast and auxiliary lymph node on the left. I completed my chemo and will be going in for surgery at a later date.
I shivered uncontrollably for about 3 hours.  I had the same reaction after dose 2 of the Shingrix vaccine on  8/22/19 at 10:45.
Started on 4/2 10:30 PM. Fever ranging from 99.9-103, muscles pain, swollen underarm lymphnods left side, head ache, extreme fatigue, light headed, nauseous. Continues on now 04/04
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. In 2014 an unspecified number of patients received improperly stored COMVAX (lot #, expiration date and dose unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Patient had swelling, redness, and heat around injection site.  Three days after injection- it kept getting bigger/worse.  She went to urgent care and was diagnosed with Cellulitis.
severe pain in injection site since first Shingrix shot (Oct 10th 2020).; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were as follows: Age at vaccination was around 65-67year old. Pharmacist reported that patient received dose of shingrix and since then she was experiencing severe pain in injection site. It was reported that patient's doctor gave her strong medication for the pain but patient was still suffering. The reporter consented to follow up. This case has been linked to US2020212988 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212988:same reporter
My ejection fraction went down to 35 with no known other explanation after months of discussing with doctors.
Funny chemical taste in the mouth; Felt groggy like someone had given the patient a sedative; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Funny chemical taste in the mouth) and SOMNOLENCE (Felt groggy like someone had given the patient a sedative) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B2119) for COVID-19 vaccination.     The patient's past medical history included Total knee replacement on 21-Jun-2021.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (Funny chemical taste in the mouth). 15-Mar-2021, the patient experienced SOMNOLENCE (Felt groggy like someone had given the patient a sedative). On 15-Mar-2021, DYSGEUSIA (Funny chemical taste in the mouth) and SOMNOLENCE (Felt groggy like someone had given the patient a sedative) had resolved.            Concomitant product use was not provided.  It was reported that the knee surgery was scheduled on December last year in 2020, but due to COVID surge it was cancelled and re-scheduled. The reporter was unsure about the lot number of the second dose.  Treatment information was not provided.  The patient was glad that the patient did not have a reaction like those women who got the J and J vaccination and died from a bad, weird sinus reaction. The patient knows a social worker who received the Pfizer vaccine and has had no problems with the first dose, but reacted to the second dose.  The knee replacement was a major surgery and the patient was at the three month mark now.  This case concerns a 69-year-old female patient with no relevant medical history, who experienced the unexpected events of Dysgeusia and Somnolence. These events occurred one day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 69-year-old female patient with no relevant medical history, who experienced the unexpected events of Dysgeusia and Somnolence. These events occurred one day after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
HEMOTOMA, WELT, REDNESS, SORE PAIN, HOT TO THE TOUCH
Pancreatic attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PANCREATITIS (Pancreatic attack) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PANCREATITIS (Pancreatic attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to PANCREATITIS. At the time of the report, PANCREATITIS (Pancreatic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment received reported as intravenous treatment while hospitalized.  Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded
Information has been received from a Registered Nurse via a company representative referring to a male patient of unknown age. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with his first dose of unidentified Merck HPV vaccine (dose, name and lot number not provided) via intramuscular route. On an unknown date the patient fainted. The patient did not return to complete series, stating "the shot hurts". The patient did not seek for medical attention. The outcome of the events was unspecified. Additional information is not expected because there was no consent to contact.
Very pale felt as if she needed to pass out not responsive. Lasted 3-4 minutes even with sternal rub. Vitals all stable.
p/vax pt w/10cm x 12cm redness central induration of 8cm x9cm also tender & increased warmth swelling of whole lt thigh;
Information has been received from a healthcare worker concerning an approximately 7 year old female with no known allergies and a history of streptococcal infection several time who on 16-MAY-2001 was vaccinated SQ with a dose of VARIVAX (Merck).  0.5ml.  There was no concomitant medication.  The healthcare worker reported that the patient had developed "streptococcus" on several occasions (dates of infections are not known).  In February 2007, the patient developed a moderate  case of chickenpox followed by acute herpetic stomatitis and gingivitis.  The patient was seen in the emergency room for IV hydration, but was not admitted.  The incident lasted 6 days.  On unspecified date the patient recovered from moderate chickenpox, acute herpetic stomatitis and gingivitis.  There was no product quality complaint.  Additional information has been requested.
got really sick went to Dr she said it was the flu; Initial information was received on 25-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional (patient) via social media..  This case involves patient with an unknown demography details who  got really sick went to Dr she said it was the flu (influenza), while being received vaccine influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.    On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient got really sick went to Dr she said it was the flu (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
30 seconds after receiving vaccine patient became unresponsive and shaking . Came to after 5 seconds. Was sitting in the chair.
Initial severe cry (not normal), lethargic -not interacting normally, sleepy, fussy, continuation of severe persistent crying, high fever then fluctuation of fever with Tylenol 98-100.6 (with tylenol given), cyanosis of lips and around nose once before and once after an episode of projectile vomiting, skin rash appearing the following day after vaccination.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 23-month-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD injection (dose and route of administration were not reported) lot # N015623 with expiration date 15-NOV-2018. The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of -11.4 degrees Celsius for 2 hours and 55 minutes. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001322: US-009507513-1712USA001321: US-009507513-1712USA009066: US-009507513-1712USA009807: US-009507513-1712USA009808: US-009507513-1712USA009809: US-009507513-1712USA009810: US-009507513-1712USA009811: US-009507513-1712USA009812: US-009507513-1712USA009813: US-009507513-1712USA009814: US-009507513-1712USA009815: US-009507513-1712USA009816: US-009507513-1712USA009817: US-009507513-1712USA009818: US-009507513-1712USA009819: US-009507513-1712USA009820: US-009507513-1712USA009821.
9cm red, edema, warmth (L) deltoid. Rx CEFZIL (250mg/5ml) 1 tsp BID x10 days.
Neutrophils on 2012-12-03, clinician comment: Persistent fever peaking at 102.9F of 4 day duration with associated leukopenia (3500) and no other infectious etiology found per extensive work-up.
After shot we walked to cashier to checkout and schedule 2nd shot. After scheduling patient became limp. I grabbed her and yelled she was fainting. They placed her in a chair. She would not answer when I called her name and asked if she was ok. I asked if they could get her orange juice, there was none. I finally said are you going check her blood pressure. Her pressure on arrival was 120/80. At this time it was 90/50. Her heart rate was in the 50s. Finally she came around I had her drink some Sprite and eat a few Oreos the cashier gave her. They took her back to exam room. She threw up in the garbage can in exam room. They finally got the Dr who came in, laid her down and raised her legs. She proceeded to instruct staff to hold her legs up because she had a vagal response. She also said she remembered how she passed out while getting blood drawn in college. I said she didn't pass out from a blood draw she passed out from that shot. She left room and never returned. The staff checked her blood pressure a few times until her top number came up to 109. Staff member said she is not to get second shot, I agreed. We left the office. We were got given any instructions. I was very nervous watching her. I gave her BENADRYL. I was not satisfied that she was still drowsy. I decided to take her to the ER that evening to be evaluated. They drew blood work and she ended up being admitted to Hospital and received 3 bags of blood. Her hemoglobin and platelets were very low. She is now following up with a pediatric hematologist.
17 years old was given their first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given their first dose of the Moderna COVID-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-May-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given their first dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given their first dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported. Reporter states patient had not reported any symptoms to the contact. No additional doses, medications, or treatments have been administered in response. Treatment reported as none.
Slightly sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slightly sore arm at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) on 13-Apr-2011 and Pacemaker battery replacement on 20-Jan-2020. Previously administered products included for Osteoporosis: Prolia (injection) on 10-Dec-2020. Concurrent medical conditions included Osteoporosis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, EZETIMIBE, ZOLPIDEM TARTRATE, MAGNESIUM OXIDE, UBIDECARENONE (COQ 10), VITAMIN D NOS and IPRATROPIUM BROMIDE for an unknown indication.    On 28-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Slightly sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Slightly sore arm at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provided.   This case was linked to MOD-2021-132000 (Patient Link).
Swelling under left armpit began 2 days after vaccination and still continues 5 days after vaccination. Swelling has gone down some. Slight swelling under right armpit as well. 5 days after vaccination woke to swollen bottom lip. Some Chet pain 2 days after vaccination but that has subsided. Joint pain elbows and knees.