chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 56 y.o. male patient of CNP with history of asthma, HTN, obesity, GERD, OSA who presented to Hospital with acute respiratory failure due to multifactorial etiology: COVID-positive, fluid overload requiring 2 L nasal cannula.   Acute respiratory failure with hypoxia Initially requiring 2 L of oxygen, now weaned to room air Likely due to COVID-19 pneumonia and acute on chronic heart failure Improved   Covid-19 Virus Infection Date of onset of symptoms: 3 days PTA (1/3/23) Symptoms present on admission: Shortness of breath Date of covid positive test: 1/6/23 Vaccination status: vaccinated and boosted Imaging: CTPA (1/6/23) extensive multifocal bilateral upper and lower lung GGO Procalcitonin negative, urine Legionella and strep pneumonia negative Oxygen requirements on admission: 2 L NC Current oxygen requirements: Room air Medical therapy: remdesivir and steroids (decadron 6 mg x 10d) Consultants following: None Anticipated special isolation end date: 1/16/23   Fluid overload Acute on chronic heart failure with reduced EF Last echo 3/28 showed EF of 40±5% and grade 2 diastolic dysfunction Presenting with abdominal distention, orthopnea and bilateral lower extremity edema Good response with 60 mg of IV Lasix( 40 mg, 20 mg) Resume home medication on discharge On hydralazine, Imdur, Toprol, Entresto, and spironolactone Follow-up with primary cardiology   Asthma Resume home inhaler  Chest discomfort Presenting with chest discomfort worse with exertion Resolved Cardiac cath 3/2022 with no significant coronary artery disease Resume beta-blocker, statin and aspirin   Diabetes Hemoglobin A1c 4.7, significantly improved from previous level 9.4 Continue home medication on discharge
pt recv vax 20OCT98 6PM by 9PM felt very tired & throat felt strange;430Am awoke & upper lip & face especially the lt side were swollen & joints were swollen & ached;p/ 2 days lip & face were down;joints gave pt problems for 6wk;
Even after the 2nd shot, I still have remnants of sore bumps; Even after the 2nd shot, I still have remnants of sore bumps; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and local swelling. On an unknown date, the outcome of the pain and local swelling were unknown.   It was unknown if the reporter considered the pain and local swelling to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of shingles vaccine and the patient had sore bumps on his/her forehead close to his/her eye. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR093216.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093216:Same reporter.
Nauseated patient, tried to take vial. Worked on PA as an example. Then didn?t work at all for patient. She was given juice and water after we had her lay down on mat and pillows. She felt way better. We advised her to seek medical attention if she felt ill later.
Baby was completely healthy according to the check up on 1/17. Checked him at midnight on 1/18. Had a fever and was fussier than usual. Checked him again at 4:30AM. Was found dead at 8:30AM.  Nurse follow up on 10/01/04 states: "Positional asphyxia; cardiac arrest."
Approx. 2 days post injection patient had warm, red area about 2 inches diameter at site of injection. Not raised. Checked area and notified PCP. Told patient to come back if worsened or call 911 if trouble breathing.
None- vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided   This case was linked to MOD-2021-395985.
30 mins after vaccination caller was notified patient tested positive for covid; 30 mins after vaccination caller was notified patient tested positive for covid; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. 30 mins after vaccination caller was notified patient tested positive for covid on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available (30 mins after vaccination Covid test found positive), no effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Flumist resulted in running nose, and High fever at 102F lasted for a whole day until Tylenol was administered twice. The symptoms are exactly like a cold.
A few minutes after receiving the vaccine, the patient fainted in the pharmacy wait area. She woke up a few seconds later and was alert. She was able to answer questions like "what is your name?" "where are your?" " etc. She denied a history of fainting but did say she fainted once about 8 years ago.  She remained seated in the pharmacy waiting area for another 30 minutes and said she felt fine. She denied feeling dizzy, short of breath, and any allergic reaction symptoms.
throat started to swell this morning on one side & face is swollen in front of & below ear might be getting a fever;advised to take APAP & if swallowing becomes a problem-go to ER;
This spontaneous report as received from a female patient of unknown age via field representative refers to herself. The patient was not pregnant. On an unspecified date in 2008 (reported as "about six years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # unknown). On an unspecified date in 2011 (reported as "about three years ago"), the patient experienced shingles. The patient had fully recovered from the shingles virus (date unspecified) although the patient did have scarring from the shingles virus. The patient had not recovered from the scarring from the shingles virus. The causality was not reported. Additional information is not expected since we do not have contact information.
Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen
Patient felt dizzy. Patient first sat in a chair and then, after a few minutes, decided to lay down. She stated that she felt anxious before the shot. She did not have any itching or respiratory distress, just dizziness. She was given some water to sip on, and she sat up again for about 20 minutes. After that time she stated that she felt better and that she was now ok and decided to go home.
Diagnosed with Bells Palsy (facial paralysis). Started with earache, lead to numbness in left side of the mouth. Saturday night 5/2 followed with my left eye not blinking and I could not move the left side of my face. Went to ER and was diagnosed.
Patient reports he experienced diarrhea and profuse sweating well as itchy rash and swelling at injection site. Member states symptoms did not begin until 2 days after injection.
About 28 hours after my injection I had a sudden acute vertigo and vomiting, the next morning I was taking in ambulance to the local medical center, I was treated in the emergency room and I was inpatient for 6 days, for three days I could not raise my head without vomiting, the diagnosis was the Vestibular Neuritis; I was given physical therapy I went home on day 6 and I was required a walker to get around, I still have some dizziness today, not as bad, and I am weekly basis I am seeing Physical Therapy.
fever (max 101); waking every 2 hr, fussy, shivering episodes which stop when held;
Got flu vaccine 11/13/15. Still has bruise and indentation where shot was given. Having pain in (L) arm and neck and shoulder. These pains got worse after flu vaccine.
At 72+ hours post injection I began coughing. Coughing has persisted with clear sputum. This has required continued use of an Albuterol   inhailer  to clear airway Cough persists!
Lymph node swelling under left arm (in armpit) has lingered for six weeks.
Headache, Fever, Constipation, NauseaVomiting, Fatigue, All symptoms started 01/19/2021 @ appx 2100 Narrative:
Patient received 2 doses of COVID-19 vaccine (#1 on 17 Dec 2020 and #2 on 07 Jan 2021).  On 09 Jul 2021 he had COVID-19 testing (as part of blood drive operations), and was positive for COVID-19 (but asymptomatic).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-NOV-2015 18:03, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.7 and 2.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
blurred vision/trouble focusing eyes starting 3 days after vaccine. some light sensitivity and mild headache--has lasted 10 days so far. I have been resting my eyes, taking Tylenol as needed for mild headache.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. the patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
night diarrhea; vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (night diarrhea) and VOMITING (vomiting) 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 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced DIARRHOEA (night diarrhea) and VOMITING (vomiting). At the time of the report, DIARRHOEA (night diarrhea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 11/29/2022 Discharge Date: 11/30/2022 COVID positive Date: 11/29/2022 PRESENTING PROBLEM: Sepsis  Community acquired pneumonia, unspecified laterality Acute hypoxemic respiratory failure due to COVID-19   HOSPITAL COURSE:    Patient is a 73 y.o. female who with a lengthy medical history including depression, GERD, glaucoma, hyperlipidemia, hypertension, hypothyroidism, ADHD, anxiety, vocal cord dysfunction and chronic pain (on narcotics). The patient presented to the emergency department on 11/29 with acute hypoxemic respiratory failure and altered mental status.  She was brought in via EMS after her fiancee found her more confused, stumbling around at home and complaining of abdominal pain.  The patient was found to be febrile.    She continues to report abdominal pain that is 6/10.  This is chronic in nature and has been ongoing for 4 years since her partial colon resection 4 years prior.  She was scheduled to meet with Dr. from General surgery on 11/29 in the outpatient setting, that appointment was canceled as she was hospitalized here.  The patient denies constipation or diarrhea, reports having bowel movements about every 2-3 days at baseline. Denies nausea/vomiting. She denies cough or shortness of breath.  She is unaware of any recent sick exposures with COVID-19.  Upon admission to the emergency department she was found to be febrile and hypoxic and placed on 2 L nasal cannula, WBC elevated at 14.  Tested positive for COVID-19 and also found to have right lower lobe pneumonia on CT and questionable obstruction vs ilieus on CT abdomen. Discussed case with Dr. from general surgery who does not feel the imagining is consistent with bowel obsturction more likely ileus. She does not have a surgical abdomen. No additional inpatient testing recommended at this time. Would consider outpatient small bowel follow through if this persists  The patient was treated for CAP vs aspiration pneumonia and COVID-19. Initially started on ceftriaxone, flagyl and  Azithromycin. SLP consult completed and normal.  She was also started on solumedrol and remdesivir for COVID-19 with hypoxia.  11/30/2022 She initially was hypoxic and not on oxygen at home chronically.  She is doing markedly better today with reduced oxygen demand and has been afebrile.  She has been on room air all day. Eager to go home. Echocardiogram and speech therapy normal.
NUMBNESS AND TINGLING IN HANDS AND FEET WHICH WAS GETTING WORSE; This spontaneous report received from a pharmacist concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced numbness and tingling in hands and feet which was getting worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness and tingling in hands and feet which was getting worse. This report was non-serious.
stomach pain; constipated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN ASPART (NOVOLOG), CARVEDILOL, ENALAPRIL, AMITRIPTYLINE, LISINOPRIL, MEMANTINE, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN 81), ROSUVASTATIN and CHLORTHALIDONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did receive laxative medication and ate grains with vinegar for constipation and no improvement according to the patient.  Action taken with mRNA-1273 in response to the events was not applicable.  Follow-up received on 31-MAY-2021 included no new information   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-MAY-2021 and does not contain any new information
I tested positive for COVID-19 on 4/7/23. I had fatigue, sore throat, cough, fever, and a headache. I contacted my doctor and was not able to get Paxlovid. They prescribed Prednisone and Flonase. I have been taking Nyquil as well.  I have another appointment today because my sore throat came back, and I still have a cough.
Chills, fever 101.2 f, aches in muscles and joints, weakness in legs and arms, sweating,
The whole thing where you put needle in came off; Prevnar 13 doses when they went to open the top of it in the lab, the top of it kinda shattered; This is a spontaneous report received from a contactable reporter (Nurse) and from the Product Quality Group.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown" described as "The whole thing where you put needle in came off"; DEVICE BREAKAGE (non-serious), outcome "unknown" described as "Prevnar 13 doses when they went to open the top of it in the lab, the top of it kinda shattered."  Additional information: PQC assessment of event is "Reportable." Associated Complaint(s): 8264117. They usually unscrew from clear part that is attached to prefilled syringe and put the needle in. The whole thing where you put needle in came off. Prevnar 13 doses when they went to open the top of it in the lab, the top of it kinda shattered.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Came to pharmacy a.m. of 10/3/09 and stated he was getting a rash that was spreading over body - very itchy - also, one hand was very swollen and itchy. Took oral BENADRYL. As of 10/5 patient getting better.
pt recv vax 1150AM-2:00-2:30 grandma called stating pt had rxn to vax 30min p/receiving vax;c/o h/a then became unresponsive for a few seconds to a min;transferred by amb to ER, eval by MD & released
This spontaneous report as received from a Registered Nurse refers to a 14 year old patient of unknown gender. On 05-MAR-2014 the 14 year old patient was vaccinated with a dose of PROQUAD (lot# unspecified) injection (dose, route, location and frequency unspecified). No adverse symptoms reported. Additional information has been requested.
sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose, and the second dose via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of resolved. On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of a COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162B2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose of Vaccine was 100% effective in preventing severe disease as defined by the Centers for Disease Control and Prevention (CDC) and 95.3% effective in preventing severe disease as defined by the Food and Drug Administration (FDA) o Vaccine was 100% effective in preventing COVID-19 cases, where the B.1.351 lineage is prevalent of Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose of Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon.  The press release is available release: Please note that the "Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity" SRD has been updated to include the Press Release information. Patient was so thrilled and very happy to receive the vaccine and she did not experience anything other than a sore arm that lasted for a day or 2 after both doses. She was asking if she would not anymore have side effects since a week had passed after getting vaccinated. Patient was asking for her relative and her senior citizen father. She mentioned that her relative received his 1st dose today but was scheduled to take his 2nd dose on 05May2021. Counting the 21 days, it should be 6May2021. She mentioned that the person from the vaccination facility might have started the count of the 21 days and erroneously gave him 20 days after the 1st dose. For her father, she was asking if it would be okay for him to get the 2nd dose 22 days after. His 2nd dose was scheduled at 21 days after the 1st dose but was scheduled on a Sunday, attributing to many people at the drive thru in which they waited for 2 hours the last time they were there.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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 62-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective and covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.