chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flash pulmonary edema / acute hypoxic respiratory failure patient enrolled in the Janssen study. Patient received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022 patient presented to site via hospital transfer with a chief complaint of shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that patient woke from their sleep and complained of severe shortness of breath on 4/30/2023, it was at that time the patient called 911 and ambulance took the patient to Medical Center, patient was admitted there with flash pulmonary edema was subsequently intubated and sedated for acute hypoxic respiratory failure on 4/30/2023. Patient remained intubated and was transferred to clinic for ongoing management of his conditions on 5/1/2023. The patient's spouse reported that prior to his episode of shortness of breath for the last few weeks patient has been feeling well. Spouse denies any recent fever, chills, nausea, vomiting, diarrhea, or night sweats. Spouse reports that the patient was in their usual state of mind for the past few days as well. Patient was intubated and sedated at facility 4/30/2023. Sedated: will d/c Propofol and fentanyl - Inotropes/Pressor infusions: Levophed - 0.03 currently - IJ triple-lumen catheter placed 05/01/2023. Pulmonary: X-ray 5/1/2023 showed bilateral pleural effusions left worse than right. Patient's O2 sats remained at 100% on lowest ventilator setting. Therapy. Patient's MRSA nares were positive. - Will trial extubation once patient wakes up - propofol and fentanyl has been discontinued. - Continue vancomycin and Zosyn for respiratory infection as source for sepsis. Gastrointestinal: - Place OG tube while patient intubated - All meds IV or through tube - Protonix 40 mg IV BID Renal: Patient has a history of renal transplant in 2013. He was started on HD during last hospitalization and was discharged on 3x weekly HD scheduled. - Consult TXP nephrology - Will likely Continue 3x weekly HD Schedule with additional sessions as needed to optimize volume status. - monitor daily RFP - f/u UA as urine cultures DVT Prophylaxis: Heparin Disposition: Admitted to ICU
I have a cough. It started October 2, 2021. My left underarm hurt.  I also had a headache on the right side of my head. The left side of my head was very hot. I suspect I had a fever. I was so weak I could not get up. I also thought I was going to throw up. I went to the doctor on 10/12/2021 because my cough was getting worse. I felt like it was in my chest. I was prescribed albuterol 108 mcg/act, benzonatate 200 mg capsule, and prednisone 10 mg capsule. My doctor did not think it was covid. They just treated the cough. My cough is better but not gone.
localized swelling (up into shoulder & down near elbow), redness, heat, pain lasted 5 days;took DPH for 4 days until swelling began to receed & redness, heat began to dissapate;also used ice packs for 2 days steady;
Pt received H1N1 vaccine L thigh 5 days ago. A few says later developed redness, soreness, and pustule at site. No fever, no drainage. Doctor completed incision and drainage of abscess and wound culture done. Pt given Rx's: AUGMENTIN and BACTROBAN. Has follow up appt scheduled at this time, has follow up appt scheduled 12/23/09.
Pt recvd vax 13FEB92 & 17FEB92 exp redness/itching below inject site on reverse side of arm 6" x 2"; seen in office 20FEB to remove sutures; reaction present but fading; no treatment initiated; last immun was 10 yrs ago;
Patient exhibited distress by crying excessively for 6 hours following vaccination and did not eat during this time, neither of which are typical behaviors. He also spent more time than usual sleeping until the following day. A slight fever was detected, although not confirmed. Overall, patient seemed to be experiencing great discomfort and misery and was unable to be soothed.
Tested positive for Covid in 09Jan2022.; Tested positive for Covid in 09Jan2022.; Started feeling "under the weather" on 08Jan2022; dose number: 3; This is not necessarily an AE but this person may qualify as an at risk individual. They have marfan syndrome which puts them at risk with cardiac issues. They recently got their booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Marfan syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot number:unknown), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Lot number:unknown), administration date: 2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Tested positive for Covid in 09Jan2022."; FEELING ABNORMAL (non-serious) with onset 08Jan2022, outcome "unknown", described as "Started feeling "under the weather" on 08Jan2022"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 2021, outcome "unknown", described as "This is not necessarily an AE but this person may qualify as an at risk individual. They have marfan syndrome which puts them at risk with cardiac issues. They recently got their booster shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. Clinical course:  The patient had not covid prior vaccination. The patient had covid teste post vaccination.    The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow up (07Jan2022): This is a follow up spontaneous report from a contactable consumer. Updated information included: Added age of vaccination, vaccination month of administration, lab test sars-cov-2 test, suspect product coding, biological product. New events drug ineffective, covid-19 and feeling abnormal were added. Onset date of event immunisation was updated as Dec2021 from 2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Caller's 13 year old son has an enlarged lymph node, later clarified as above his left clavicle.; Age:13 year; This is a spontaneous report from a contactable consumer or other non hcp (patient's parent).  A male patient(reporter's son) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported), via an unspecified route of administration on an unspecified date at an unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced caller's 13 year old son has an enlarged lymph node, later clarified as above his left clavicle. Reporter states that in between the vaccines, his for this son has an enlarged lymph node, later clarified as above his left clavicle. Reclarified, reporter stated that in the absence of having the vaccine, he is learning that a single swollen lymph node can be something to be concerned about, and could be an infection, or something more serious. Reporter stated that he asked his son's pediatrician yesterday about this as event, and the doctor stated he hadn't read anything about this type of swollen lymph node being reported in this age group. Reporter stated his son had bloodwork, and it came back normal and his son is going to get a chest X-ray. On an unspecified date the patient underwent lab tests and procedures which included blood test: normal. Out-come of the events was unknown.  Information about the lot/batch number has been requested.
At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905322, 201905323, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Narrative: COVID infection following COVID vaccine series 04/01, Pfizer, dose #1 04/22. Pfizer, dose #2 11/12 pt cc: cough exposure: unknown 11/17 COVID swab, result: detected.
1403 Numbness left arm BP 177/93 Hr 56, resp 18, Sats 99% denies Hx of hypertension. Monitored 15 more mins. 12:19 BP 146/83, HR 64 reg, resp 16. Reports numbness improved. AAOx4, strength 5/5 all extremities. Left for home with her husband.
Fever; chills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 17May2021 at 00:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was having stone fruit allergy. The patient did not receive any concomitant medications in two weeks. 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 vaccines within four weeks prior to the vaccination. On 17May2021 at 21:00, the patient experienced fever, chills and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events fever, chills and body aches were recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
I am having facial numbness in my lower chin/Jaw area that comes and goes. It started again on the afternoon of June 2, 2021 and continued into the next day, however the numbness was increasing to different areas on my face. My Dr urged me to go to the ER.  They ran several tests and could not come up with a logical solution for the numbness. The symptoms begin on May 17, 2021
On the left vastus lateral pt thigh was very red and swollen on the right vastus lateral thigh was swollen pt had a rash resolved in day 2.
At the time of vaccination, felt stinging pain that radiated from deltoid down to back of hand and up neck, which has persisted with numbness.  Bruising and redness developed from deltoid to elbow, over the next couple of days.  Also had mild malaise and fatigue on the first day, but these have resolved - Ibuprofen 600mg TID, warm soaks.
Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart rate, blood pressure was 183/110. Was hard to breathe, clammy, faint, confused, and panicky. Left arm went numb. I went to hospital twice, and clinic twice due to the symptoms coming and going.
Onset of fever 1 day after 2 month vaccines. Fever persisted 5 days, then abated spontaneously.
Severe arm pain and severe restriction of range of motion that persists one year later. Atrophy  of muscle is visible and testable.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-OCT-2011, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-SEP-2013, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and carbamazepine for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
triggered shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (triggered shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (triggered shingles) (seriousness criterion hospitalization). At the time of the report, HERPES ZOSTER (triggered shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information provided. Concomitant medication information not provided.  Company comment: Limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.  It is not confirmed that the patient received mRNA-1273 (Moderna COVID-19 Vaccine)   This case was linked to US-MODERNATX, INC.-MOD-2021-028695 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-028695:Patient case
Large local reaction AVA #6 site: redness, swelling, induration, pain, bilateral kidney, back and groin pain  o  Feeling terrible o  Having symptoms fatigue, weakness, pain right arm, bilateral flank pain o  Generalized pain left arm/deltoid, axilla and bilateral kidneys w/groin tenderness since Monday evening w/o relief. Tuesday worse w/o increase in discomfort today (Wed) o  Feeling tired or poorly o  Fever o  Chills  o  Neck symptoms c/o stiffnes to neck following tension  o  Genitourinary symptoms bilateral groin pain, no urinary symptoms, denies hesitancy, frequency, no STD exposure  o  Skin symptoms right deltoid red swollen hot to touch   o  Musculoskeletal symptoms
Information has been received from a physician concerning a 4-month-old female who on 28-MAR-2007 was vaccinated PO with the second dose of rotavirus vaccine live (human-bovine). On 29-MAR-2007, the patient developed diarrhea. On 31-MAR-2007, the patient was seen by the physician as she was still experiencing diarrhea. At the time of this report, the final outcome was unknown. Additional information has been requested.
Patient was sitting out in front of the pharmacy so that we could observe her for the 15 minute wait period. (Dose given 3:44pm) Pt stated that she felt like her throat was tight, she was hot and that she was light headed. (3:46pm)  We grabbed an ice pack to place on the back of her neck.  She then stated that she felt like her tongue was swelling and that she was having trouble breathing and she was afraid she might faint.  We helped her to the floor and had her lay down flat to see if that would help her breathing.  It did not help, and her shortness of breath became apparent. We called 911 and administered 1 Epi-pen dose. (3:48pm)  The Epi-pen did help and she began to have stronger breaths and she said that she could feel that it was helping with the swelling as well.  The paramedics arrived and took over treatment at that time. She was transported to the hospital by ambulance.
I went  the store had my vaccine shot. Waited for 15 minutes and felt Fine. I went home afterwards. On the 2nd day of I started to hurt in my arm and had a huge bump.  The Bump was not red and itchy. Overtime it shrunk down.
1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart) had resolved.            Treatment information was not provided. List of concomitant medication were not given.
Immediately after the shot : shocking headache in the middle of the head nothing too bad.   Began with chills, and fever. At 12am.  12:30 started to sweat and body aches  1am stuffy nose and face starting to swell along with my throat. Rapid irregular heart beat, chest pain, shortness of breath, impending doom   Still have some chest tightness, injection site pain, and sore back muscles but everything else has subsided
UNABLE TO FINISH LAST DOSE BEFORE TRAVELLING; This spontaneous case (PVX2019-928) was received from a pharmacist on 18-Apr-2019. It describes a 75-year-old elderly male consumer who was "unable to finish last dose before travelling. The consumer was receiving Vivotif (lot no: 3003253 and expiry date Dec 2019) as a travel vaccine.   Case report: The consumer took the first dose of Vivotif on 16-Apr-2019. He stated that he would not be able to take the final dose before travelling to the endemic area.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "unable to finish last dose before travelling" was unknown.  Company's Comment: The causality of the event "unable to finish last dose before travelling" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "unable to finish last dose before travelling" was considered as not applicable.
chills; feeling really really cold; headache; a little bit of body ache; fever; head hurts; body is aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 (Lot number: EW0173) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1 Covid 19 vaccine , Lot # EW0173, Anatomical Location: right arm , Date: 02Aug2021, Age at Immunization if date not available: 18), administration date: 02Aug2021, when the patient was 18 years old, for covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 25Aug2021, outcome "not recovered", described as "feeling really really cold"; HEADACHE (non-serious) with onset 25Aug2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "a little bit of body ache"; PYREXIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "fever"; HEAD DISCOMFORT (non-serious) with onset 25Aug2021, outcome "not recovered", described as "head hurts"; PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "body is aching". Therapeutic measures were taken as a result of chills, feeling cold, headache, pain, pyrexia, head discomfort, pain.  Additional Information: No illness at time of vaccination. No prior vaccination (within 4 weeks). No relevant test reported. CONS - use of fever reducing drugs and pain relievers. Product Complaint: Description of complaint: She states her chills are really bad, she has a fever, her head hurts and her body is aching. She is taking Ibuprofen and that's calming it down a little bit but not taking it all away. Ibuprofen 200mg NDC 49035-912-12 Expiry Apr2024 P124831.  No follow-up attempts are possible. No further information is expected.
Pt explained he had a history of poor reactions to vaccines historically (flu-like symptoms with Tdap and trigger if seizures with flu shot). Explained to pt potential risk may occur d/t poor history but decided to vaccinate d/t no previous history of covid vaccine. After administration. pt started to feel light headed and dizzy. Started to sweat, have hand tremors, and stated he felt intense tinglines all over hands. Took BP reading, was 80/63mmHg. Administered 0.3mg of Epi-pen into right-thigh hand called 911. Paramedics came and took patient to Emergency room.
? Patient told the NP his past that whenever he gets a vax he passes out. Has a family history of that.  ? Staff was the vaccinator, he brought him out after vaccinating and he started feeling faint.   ? EMT Immediately asked staff for the emergency bag   ? Patient 1 passed out on chair, patient 2 behind him was a doctor and helped EMT move PT 1 to the floor  ? Per EMT He started ?posturing? on the floor, looks like a seizure for approximately 30-45 seconds   ? EMT was going to call 911, manager had phone in hand already and called 911 at 11:59 AM , stepped away because it was too loud and provided information that patient was seizing  ? RN tended to PT1 , RN checked BP and O2- normal conditions   ? Patient came to, and was responsive with name and dob   ? EMS took patient away on wheelchair