chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Deceased 11/17/2021; Hospitalized 11/10/2021; COVID-19 positive 11/10/2021; fully vaccinated  BRIEF OVERVIEW:  Admission Date: 11/10/2021   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure [J96.00] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 57 y.o. female who initially presented on 11/10 for 3-4 days of worsening shortness of breath, diarrhea, and nonproductive cough.  She had pitting edema and signs of fluid overload on CXR and was diagnosed with COVID on arrival.  She is on 5 L oxygen at baseline and was started on high-flow nasal cannula and initially admitted to hospitalist service.    She was diuresed aggressively. She was started on steroids; did not qualify for Remdesivir due to kidney function.Her oxygen requirements continued to increase and she was transitioned to 100% high-flow nasal cannula with non-rebreather mask. Overnight on 11/11, she desated into low 80s and was placed on BIPAP and transferred to ICU service due to concern for impending intubation.    Her respiratory status declined and was intubated on 11/13.  We had multiple conversations about her likely poor prognosis considering her baseline respiratory status, and patient elected to proceed with intubation at that time.  She was sedated and paralyzed, and she subsequent required initiation of norepinephrine. Her respiratory status continued to worsen and we began proning on 11/14. She responded to proning and was continued on a 20:4 proning schedule.   Palliative care was consulted on 11/15 after family expressed concern about patient's grim prognosis and likelihood of tracheostomy and long-term care even if she survived this illness. On 11/16, palliative spoke with all first-degree relatives, and they decided to transition to DNR and comfort care. Paralytics turned off and patient pronounced dead on 11/17/21 at 12:45AM. Family at bedside, condolences offered.
Fever within 24 hr, nausea & vomiting 3 days, rash within 3 days, tingling in fingers -> hands -> arms, muscle aches & weakness 3 days, back ache 5-7 days.
Pt noticed redness, soreness, and swelling on leg about 40 minutes after receiving shot. Mom brought her in today, area was much bigger. Antibiotics were given.
Immediately after receiving first dose of Pfizer COVID-19 Vaccine: received vaccine at 4:31pm, experienced heart palpitations, increase in heart rate and blood pressure, tingling hands. Stayed at vaccine site for additional 15 minutes of monitoring (totaling 30 minutes of monitoring). Around 7:00pm began feeling nauseous with a severe headache and muscle pain throughout body. Slight numbness in palms of hands with a bit of a burning/discomfort sensation. Shaking and muscle spasms in legs. Extreme nausea, Vomiting occurred between 7:30pm - 9:00pm. All symptoms described above continued throughout the evening into the next morning. Doctor advised Tylenol, with 1000mg taken at 9:00pm. Kept myself well hydrated with water, Gatorade, pedialyte. Next day symptoms thus-far: nauseous, lack of appetite, still have strange sensation in palms of hands, very sore at injection site, neck, and back, very cold feet and hands. Sporadic heart palpitations and sporadic tachycardia.
PT WAS SUPPOSED TO RECEIVE MODERNA 3RD DOSE BUT BY ACCIDENT RECEIVED PFIZER FOR THE 3RD DOSE. NURSE PICKED UP THE WRONG BRAND OF VACCINE AS THERE WERE 2 CIRCULATING LOT NUMBERS AND VACCINE BRANDS FOR THE VACCINE CLINIC FOR THAT EVENT.
The patient reported to pharmacy around 6:45pm with pain near his pectoral muscle that had begun around 6:30 pm. The pain was mostly in his armpit and was severe enough that he couldn't lift his arm without pain increasing. His vaccine occurred around 4:20pm and he then returned to work stocking shelves.
"I went from a little pain in my hand"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as ""I went from a little pain in my hand"".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ran 104.5 Temperature.  Signs of hives and rash on legs and back.  Site of shot was swolen and very red.  Lethargic at times.  Refusing anything to drink of eat.  11/03/2008 MR received for DOS 10/21/08 with DX: FUO. Likely immunization reaction. Pt presented to ER with fever, rash, lethargy and fussiness. Temp 104.3 in ER. PE (+) for redness with nodules on R & L thigh. No rash noted. Tx with abx awaiting cx and d/c same day.
my 1st two fingers (like my finger fell asleep) and had very little feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in left arm, administration date 13Jan2021 at 10:00 (Lot number: EL0142) at the age of 43 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies Yes" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: HYPOAESTHESIA (non-serious), outcome "recovered", described as "my 1st two fingers (like my finger fell asleep) and had very little feeling". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The event experienced by the patient lasted about 2 and 1/2 hours. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Immunization 9-17-21, chest pain 9-18-21 lasted 24°, gone by Monday.
Shortness of breath; Chills; Fever; Muscle aches all over; Weak body; Arm pain; Diarrhea; Nauseous; Haven't wanted to eat in over 13 hours when symptoms began; Severe headaches; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 07:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included patient was obese. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and topiramate (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously took cefixime (MANUFACTURER UNKNOWN), phenytoin sodium (MANUFACTURER UNKNOWN), vancomycin (MANUFACTURER UNKNOWN), fosphenytoin sodium (MANUFACTURER UNKNOWN) and possibly experienced drug allergy but it was unknown. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 17:30, the patient experienced shortness of breath, chills, fever, muscle aches all over, weak body, arm pain, diarrhea, felt nauseous, the patient didn't want to eat and had severe headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness of breath, chills, fever, muscle aches all over, weak body, arm pain, diarrhea, felt nauseous, the patient didn't want to eat and had severe headaches was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Syringe malfunctioned and leaking during administration; A spontaneous report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced syringe malfunctioned and leaking during administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, a health care provider administered the mRNA-1273 vaccine to a patient.  During the administration, the syringe malfunctioned and leaked during administration.  The health care provider was uncertain if the patient received the full dose of the vaccine or how much of the vaccine was spilled. The patient had no observable symptoms and did not receive any treatment for the event.  Action taken with mRNA-1273 in response to the event was not reported.   The event, syringe malfunctioned and leaking during administration, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, syringe malfunctioned and leaking during administration, to study drug.; Reporter's Comments: This case concerns a  patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.; Sender's Comments: No adverse event
This spontaneous report as received from a Healthcare worker refers to two unspecified patients. The patients were vaccinated with the first dose of RECOMBIVAX HB (route, dose and lot # were unknown) on an unspecified date in November 2012 and the second dose on 20-FEB-2013. No adverse effect reported. The outcome of event was unknown. Additional information has been requested.
Sick as a dog since; Hot and cold; Feeling weak; Achy; Nauseous but cant throw up; Arm hurts; she got in the right arm and now it hurts; she was dying; This is a spontaneous report received from a contactable consumer (patient's mother). The reporter reported for her twin daughters. This is one of the 2 cases.  A 22-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 20Apr2021 3 pm (Batch/Lot number was either EW0150 or EW01S0, caller not sure, there was not an expiration date, NDC number, or dosing information on the vaccine card) as single dose in the right arm at the age of 22-year-old for COVID-19 immunisation.  Medical history included her thyroid surgically removed on 17Sep2020 and taking medications for it (they thought it was cancerous but it turns out it was not), postural orthostatic tachycardia syndrome from Mar2021 and ongoing. No family medical history relevant to events. The patient's concomitant medications were none. The patient received the 1st dose of bnt162b2 (BNT162B2, lot number ER2613) in left arm on 30Mar2021 11 am. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No events occurred following prior vaccinations. On 20Apr2021 since vaccination the patient experienced sick as a dog since, hot and cold, feeling weak, achy, nauseous but can not throw up, arm hurts,  she got in the right arm and now it hurts, events were described by the patient as she was dying. No event required a visit to Emergency Room or physician office. No relevant tests performed. The outcome of events was not recovered, events were still ongoing.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
began limping Tues evening 5-6Pm; by Wednesday evening; swelling of lt knee & lower aspect of thigh 2x nl leg size; no swelling @ injection site; no fever; severe amt of pain, unable to walk; no energy seen by MD 1JUL93;
Information has been received from a physician concerning a male child (age not reported) with no allergies or medical history who received two doses of MMR and had a low titer (< 0.91) for mumps. The second dose was given on 05-SEP-1996. Unspecified medical attention was sought. The patient's outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
At time I gave immunizations, there were no signs of any adverse events(normal). When patient came back her arm was red from the immunization. No temperature on child(very alert).
patient was supposed to receive the DAPTACEL vaccine but was administered PENTACEL/no AE; patient was administered PENTACEL while administering HIB part of the vaccine was only administered and not the DTAP/no AE; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case received from a physician via phone via call Center.  This case involves a 18 months old male patient who was supposed to receive the DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] but was administered a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered) batch number: U6842BA, expiry date: 05-JUN-2021 via an unknown route in unknown administration site for prophylactic vaccination on 17-Nov-2020 while administering Haemophilus influenzae type B vaccine [HIB] part of the vaccine was only administered and not the DIPHTHERIA, TETANUS, AC PERTUSSIS [DTAP] (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and inappropriate reconstitution technique (latency: same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache, rapid heartbeat, vomiting, dizziness, joint pain and fainting. ER doctor said blood tests showed concern of clotting, then after dye test said was ok
Irritation; Itchy; Rash; Red rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Irritation), PRURITUS (Itchy), RASH (Rash) and INJECTION SITE ERYTHEMA (Red rash on left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041l20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Many cold medicines---Heart race or pass out. Immediate reaction), Drug allergy (Vicodin ----Nausea and throwing up. Needed to take anti nausea med), Drug allergy (Oxycodone---Nausea and throwing up. Needed to take anti nausea med) and Drug allergy (Anesthesia- Nausea and throwing up.  Needed to take anti nausea med). Concomitant products included IBUPROFEN and PARACETAMOL (TYLENOL) for Back pain, MULTIVITAMIN & MINERAL and VIT D [VITAMIN D NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Jan-2021, the patient experienced SKIN IRRITATION (Irritation), PRURITUS (Itchy), RASH (Rash) and INJECTION SITE ERYTHEMA (Red rash on left arm). The patient was treated with CORTISONE at an unspecified dose and frequency. On 16-Feb-2021, SKIN IRRITATION (Irritation), PRURITUS (Itchy), RASH (Rash) and INJECTION SITE ERYTHEMA (Red rash on left arm) had resolved.            .   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23 JUNE 2021, vaccine hypersensitivity form was added(date of second dose and outcome of event was added).
pt recv vax 29AUG95 & 9SEP95 pt exp anaphylactic rxn erythema multiforme, gen arthralgias & swelling in joints;tx in ER w/antihistamine & steroids
sore arm; felt hungover for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HANGOVER (felt hungover for 24 hours) in a male patient of an unknown age 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 PAIN IN EXTREMITY (sore arm) and HANGOVER (felt hungover for 24 hours). At the time of the report, PAIN IN EXTREMITY (sore arm) and HANGOVER (felt hungover for 24 hours) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    Reporter did not allow further contact
Chills, severe fatigue, muscle aches, fever, tachypnea headache, congestion
Pain in area; Fever; Fatigue; Chills; Dry cough; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN) and norethisterone acetate; ethinylestradiol; ferrous fumarate (BLISOVI FE); all were taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 20Mar2021(at the age of 23-year-old) as a single dose for COVID-19 immunisation. 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 10Apr2021 at 04:00, the patient experienced pain in area, fever, fatigue, chills and dry cough. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events pain in area, fever, fatigue, chills and dry cough were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Pt had swollen, red arm, increased temperature 102F-104F, extreme malaise and chills, post vax.
rash all over body for 3 days prior to visit on 12-29-06, been using hydrocortisone.
Pertussis - patient slept more then normal amounts of time after receiving her DTaP shot, seeming very lathargic, and when she was awake, would scream non-stop like she was in severe pain.  This lasted about 2-3 days, along with a fever.  We have since not vaxed her for Pertussis.
BP 188/113 P107. Itching on chest and upper arms. States feeling weak and feels funny. States feels like have heart palpations. Diaphoretic.
arm redness, pain and swelling had subsided after injection by 2/10 but then on 2/12 it flared up again and was much worse than before, did not go away for a week. Very swollen, and extremely itchy.  I can still see a slight circular mark on the left arm. I had the second dose in my right arm on 3/5 which is still itchy and sensitive.
Client c/o N/V, swollen lips, and feeling intoxicated. C/O numbness in hands. Went to ER, unknown labs were drawn. Pt sent home without receiving any meds. Told to rest and increase PO fluids x 24 hours.
I started having unseasonal allergy symptoms on Monday afternoon of 06/06/2022 which persisted through until the following Wednesday. We finished with our local farmer's market that day at around noon, and I suddenly began to experience diarrhea. I thought it may be due to a food related issue. I continued on with my day but around 04:15 that day I noticed that I was incredibly sleepy and was asleep by 05:00PM that day, which is very strange, since I never have the need to take naps. I slept from that time on Wednesday until the following Friday with the exception of getting up to use the restroom and drink water. That Friday morning, my husband suggested taking a COVID-19 test. I took an at home test which was positive. I called my doctor's office and had a telehealth appointment. Since I had recently had a physical with lab work done and they knew that my health was good, and I also was not experiencing fever or headache she advised that I only take a Paxlovid prescription if I develop a fever or cough. I did develop a cough that evening that continued through the next day and my sense of smell and taste became impaired, but I did not end up taking the Paxlovid prescription. My symptoms began to improve over the next few days and by Monday, I called the pharmacy to inform them that I would not need the prescription. The fatigue persisted after I recovered. I really only just recently began to feel that the fatigue has lifted.
pt exposed to sibling w/chickenpox, today is 14th day & started w/a few red spots on back, face & head;
Rash (slightly itchy) appeared at injection site 14 days after injection. Has lasted for 3 days so far.
Menstrual like cramping yesterday evening (Thursday 10/28/2021), with sensation of bloating and heat in lower abdomen, small (dime size) skin lesion in vaginal area.  Followed today (Friday 10/29/2021) by vaginal bleeding, continued discomfort and general lethargy.  Normal menstrual cycle ended 10/15/2021
Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL. The patient experienced syncope after receiving the GARDASIL. It was reported that the patient had a viral illness at the time of injection. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
A report has been received from a Health Professional concerning, subject gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 02-Dec-2013. The patient was administered expired FLUMIST on 02-dec-2013. The outcome of the event of administered FLUMIST is unknown. The report was considered to be non-serious.
Per patient "When I returned home I started my daily routines and seemed to be fine.  However about 3pm my upper arm was hurting and seemed sore from shoulder to elbow.  By 5pm, my upper arm had swollen up from shot site to just above the elbow and was getting red. Also at this time I was starting to feel like I was coming down with the flu having cold and hot spells and temp rising, by 8pm I was in bed with headache, temp of 101-102, cold/hot spells and shivering.  Arm was very sore and there was a red rash area on my upper arm.  I was starting to have nausea but I didn't vomit. My condition was like this from Tuesday afternoon through Wednesday at approx 10pm when my temp finally broke. I was still in bed through Thursday evening. Arm swollen/rash until Mar 2 and now almost back to normal, arm still achy."