chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted, laid patient down immediately -HR 46, Oxygen 99%, Blood Pressure 100/70 at 11:46 continued to monitor 11:48 HR 48, BP 110/80, O2- 98% 11:51 HR 51, BP 100/70, O2- 99%  11:56 patient sat up and drank some water, HR 54, BP 122/80, O2-99% 12:08 HR 45, BP 116/76, O2-99% patient waited and felt better.  Wheeled to car and wife drove him home.
This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history was not reported. The patient received an improperly stored dose of PROQUAD (route not reported, lot # L031603 and Exp. date 18-FEB-2017) on 07-JAN-2016. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been expected.
"flutter like" heart symptoms; This is a spontaneous report received from a non-contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "flutter like" heart symptoms. The outcome of event was unknown.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 25-FEB-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius)for a total of 16 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Father reports that at approx 2pm, patient had acute onset of stuttering.  Would start every sentence or every other sentence with, for instance, "You, you, you, you know, ..."  Lasted until dinner time with almost every sentence, then in evening only occasionally, and today resolved.  Denies fever, achiness, cold or cough symptoms.  No difficulty with balance, walking, or coordination.  No known visual changes.  No complaints of pain.  Never had similar symptoms before, except that a family member noted him stuttering once 2-3 weeks prior.
Couldn't see out of right eye.  Called eye doctor, sent to retina specialist.  Blood and swelling by retina.
No additional adverse effect reported; a male Patient received improperly stored M-M-R II (lot R031680 & expiration date 11/1/2020).; This spontaneous report was received from a medical assistant referring to a 5 years old male patient. Concomitant therapy included sterile diluent. Information about medical history and concurrent conditions was not provided.        On 05-NOV-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R031680, expiration date 01-NOV-2020; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was -58 degrees Fahrenheit and +46 degrees Fahrenheit (19.13 degrees Fahrenheit) for 1.5 hours. There was previous temperature excursion above 47 degrees Fahrenheit (54.93 degrees Fahrenheit) for 15 minutes and -58 degrees Fahrenheit and +46 degrees Fahrenheit for 12 hours and 15 minutes.  Data logger was involved. No additional adverse effect was reported.
Guardian requesting Pfizer Monovalent 1st dose, but I accidently administered Pfizer Bivalent for her age @10:00AM. Pt. was advised to wait 15 min for any adverse reaction, at 10:20am checked on pt., pt. states she felt fine and Guardian stated she was fine.
PATIENT IS 14 YEARS OLD GIRL WHO CAME IN FOR HER COVID PFIZER VACCINE WITH HER DAD WHO ALSO WANTED A PFIZER SHOT. The nurse acciedntly gave the 14 years old girl 2 shots of the pfizer vaccine. we kept the patient for 0 min for observation ,patient reposrted her arms are numb but was doing ok
tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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: FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 18 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an adult dose of VAQTA, intramuscular instead of a children/adolescents dose (Dosage, dose number, lot number and expiration date were not reported). No other suspect or concomitant therapies were reported. No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
approx 10min p/vax pt exp the sensation of an electrical wave from lt deltoid down to foot;this was followed by numbness & tingling in lt leg;
Erythema tracking from injection site of the left arm deltoid region to the bicep region, measuring 95mmx 45 mm.
CHILLS  FEVERISH  BODY ACHES  JOINT PAIN  HEADACHE
Is it normal to for your arm to swell/Is it normal for your arm to swell after you get shot one; 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 PERIPHERAL SWELLING (Is it normal to for your arm to swell/Is it normal for your arm to swell after you get shot one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Is it normal to for your arm to swell/Is it normal for your arm to swell after you get shot one). At the time of the report, PERIPHERAL SWELLING (Is it normal to for your arm to swell/Is it normal for your arm to swell after you get shot one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No Treatment medication was reported.
patient received expired vaccine of FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional, physician, non-healthcare professional via Media Information (under reference: 00814496).   This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249(CLUSTER).  This case involves a 14 years old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  At time of reporting, 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 holder's compliance with the requirements set out in the 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.
I had a fever, chills, body aches, runny nose, diarrhea, headache, fatigue, nasal congestion, cough, and constipation. I tested positive for COVID-19 at home. I went to the doctor, and they tested me again. They prescribed me PAXLOVID. I still have a cough and fatigue.
Tired am, 2:00 pm immediate onset of sweating, nausea,   Vomited, weakness , and extremely sick feeling.  Symptoms lasted approximately 15 minutes and then subsided.
Patient is a 72 y.o. male with a history of Parkinson's disease, nonischemic cardiomyopathy, orthostatic hypotension, factor 5 Leiden with DVT on Pradaxa, and hospitalization from 12/2-12/9/22 for PNA complicated by dysphagia and eventually discharged to SNF who presented to RMH 3/10/2023 from home with fever, cough and dyspnea and found to have COVID-19. Clinical decline 3/11/23 requiring HHFNC and broadening of abx. Course c/b dysphagia requiring tube feeds. Prolonged stay for PEG placement. Course further complicated by aspiration event 3/21/23 requiring HHFNC and delaying PEG. PEG ultimately placed 3/24/23.   1. Acute hypoxic respiratory failure: required 3L on admit secondary to COVID 19. CT Chest on admit with b/l patchy infiltrates and improved LLL consolidation. Worsening hypoxia on ABG 3/11/23, required HHFNC. CXR 3/11/23 w/ b/l stable airspace disease. Resolved until sudden onset hypoxia on 3/21/23, suspect aspiration given thick secretions. Placed back on HHFNC. Antibiotics completed for aspiration pneumonia. On room air since 3/23/23. Resolved. 2. Sepsis: Febrile and tachycardic on admit likely due to COVID 19 but could not rule out underlying bacterial process. Initially treated with rocephin/azithro, broadened to vanc/cefepime 3/11/23 with recurrent fever, hypotension, tachycardia. Discontinued antibiotics 3/12/23. Recurrence of sepsis 3/21/23 as below. Resolved. 3. Aspiration pneumonia: Episode of sudden onset hypoxia while in endo for PEG 3/21/23. CXR with LLL infiltrate. Febrile, tachycardic, tachypnic. MRSA negative. Sputum culture, blood cultures negative. Unasyn transitioned to PO Augmentin, completed 3/25/23. 4. COVID-19 Pneumonia: positive on admit. Hypoxic, IV decardon initiated for 10 days. Started Remdesivir 3/11/23 for worsening clinical conditions. Recommend repeat CT chest in 3 months to ensure resolution of pneumonia.  5. Dysphagia: Chronic issue, recent on modified diet at SNF. SLP followed for witnessed aspiration. FEES 3/11/23 with profound aspiration. NPO, corflo and TF. SLP followed. Pt pulled out corflo 3/13/23 and replaced 3/14/23. Failed MBS 3/17/23 with recs for NPO. Aspiration event while patient down for PEG. PEG placed 3/24/23. Tube feeds through PEG initiated 3/25/23. 6. Parkinson's disease: follows with Dr (neuro). Continued home primidone.  7. Factor 5 Leiden with DVT: per history. Held pradaxa as pt NPO and unable to give via tube, started lovenox bid 3/11/23. Eliquis not option due to interaction with home primidone. Coumadin initiated 3/24/23, plan for lovenox bridge. 8. Orthostatic Hypotension: per history. Held home florinef while on dexamethasone, resumed with midodrine at dsicharge. 9. NICM: follows with Dr (cardiology). TTE 2018 EF 55-60%%. Euvolemic on admit. 10. Chronic pain: follows with Dr (pain medicine). Previously had IT pain pump but has been off due to recent MRSA infection from wound. 11. Wounds: sacral wound s/p wound vac. Stage IV sacral pressure ulcer and unstageable left lower back pressure ulcer, both POA. ET followed. 12. Severe malnutrition: secondary to chronic illness with dysphagia and poor intake with chronic weight loss. RD followed.
Caller states two colleagues right now who had the Pfizer COVID vaccine are sick and they have been put in ICU since 30Jul; This is a spontaneous report from a contactable consumer.  This consumer reported that a patient (colleague) of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), on an unknown date at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The consumer states the colleague right now who had the Pfizer COVID vaccine is sick and  has been put in ICU since 30Jul. The outcome of the event was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101133823 same reporter and drug, different patient and event
1/11 I had an EKG that was normal. after receiving the vaccine, my chest started hurting, both arms started hurting really bad. 30 hours later the arms stopped hurting but the chest was still hurting. back started hurting but went away but the chest still hurt. I went to Dr. 3 days after i started hurting and he did an EKG 1/25 and that evening the DR called and said "GO TO THE HOSPITAL YOU ARE HAVING A HEART ATTACK. CALL AN AMBULANCE." I took an ambulance to the hospital and had surgery and had 3 stints put in.
A couple of months after receiving the vaccine, I've been experiencing cramps in my skull area. I've been trying to reduce the pain by taking ADVIL or letting the pain subside on its own. I've also developed an eye twitch since then as well. The twitch developed in September while the skull pain developed over the recent weeks. I saw a specialist, but they stated these symptoms could be fixed through exercise. They didn't really do a thorough examination to diagnosis my symptoms and case.
Where the patient had filler injected in her face was swollen; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female 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 14Apr2021 at 19:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included dermal filler injection (the patient had filler injection in face back in January) on an unknown date in Jan2021 and unknown if ongoing. The patient was not allergic to medications, food, or other products. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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. On 16Apr2021 at 07:00, where the patient had filler injected in her face, was swollen. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the event where the patient had filler injected in her face was swollen was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports pain that started 2 hours after injection in arm/shoulder that radiates up to clavicle, decreased ROM, reports not being able to lift arm.  Patient spoke to Dr. on the phone on the evening of 5/10/2022, advised patient to ice area, gentle ROM, and can take her prescribed pain medication as needed for pain.
I thought I was having a stroke; Little bit of pain in my arm; Tingle on right side of my lip; little bit of numbness; I have some numbness in my left arm, my right throat and my fingers of my right hand; Tingle on right side of my lip; little bit of numbness; This is a spontaneous report from a contactable consumer (Patient). An 80-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/lot number: FF8839) via an unspecified route of administration on 22Sep2021 as dose 1, single for COVID-19 immunization. The patient's medical history had included cellulitis (at that moment but patient used a walker) and debilitating in the legs. The patient concomitant medication was not reported. On 23Sep2021, the patient had experienced little bit of pain in arm but after couple of hours, patient suddenly may got something like tingle on right side of the lip and little bit of numbness that patient had some numbness in the left arm, its right throat and fingers of right hand and that last did to the next day and patient was just wondering than all the of the sudden just went away but if this was the reaction to the first one, I am afraid to take the second one and I called my doctor about that and I tell that I was going to get a response and this had four day now and I have not had a response. Patient had a concern of having a stroke. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 12:30 as dose 5 (booster), single (Lot number: GJ6742) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 at 14:30 as dose 1, single (Lot number: EL3247), in left arm, on 25Mar2021 at 14:45 as dose 2, single (Lot number: EL3247), in left arm, on 30Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 05Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FL3197), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL, start date: 15Oct2022; PROGESTERONE, start date: 15Oct2022; BUPROPION HCL ER; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 25-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Dx with Plaque Psoriasis by dermatologist, is continuing treatment with That  clinic.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer 7 expired moderna doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer 7 expired moderna doses). In November 2021, EXPIRED PRODUCT ADMINISTERED (Administer 7 expired moderna doses) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided.No treatment medications were reported.
Moderna COVID-19 Vaccine EUA Very sore, stiff right  arm. Pain at its worst running from base of neck to forearm (right arm). Mild full-body aches Headache, turning into headache as base of head Watering eyes, runny nose, sniffles Low grade fever (99F) mild chills
Reported he walked to health department from home. After administration of vaccine, complained of tingling in right hand and wrist at 1544.  Drank some bottled water. Complained of feeling sleepy and a headache. Began nodding off and then became unresponsive. BP at 1600: 98/78. Pulse: 80. BP at 1607: 100/70. Pulse: 72. Was beginning to rouse around this time but drowsy. Respirations 16. BP at 1615: 86/60. 911 called. Taken to hospital via ambulance at 1628.
Pediatric Pfizer 0.20 ml was admin instead of the adult dose. This was dose #1 of COVID vaccine. Both adult and peds vials were out at the same time. Caregiver drew up the peds dose and had it verified by another MA. Both MAs missed the error. Provider and patient were made aware. No adverse reaction occurred. Pt will come back to clinic for the adult dose in 3 weeks.
No aditional adverse effect reported; The patient was inadvertently administered with a dose of expired but properly stored VAQTA; This spontaneous report has been received from a pharmacist referring to a 62-year-old patient of unknown gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 13-AUG-2020, the patient was inadvertently vaccinated with a dose of expired but properly stored hepatitis A vaccine, inactivated (VAQTA) injection, vial, strength: 50/1.0 U/ml, 1 dosage form, lot # S018419, expiration reported and validated as 12-JUL-2020, as prophylaxis (dosage schedule, route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported) (expired product administered). No additional adverse effects were reported (no adverse event).
Varivax given on 1/26/99 and child now dx'd with possible infection on 11/2/00. Has macular papular lesions of face, extremities with pruritus.