chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 6 hours ? headache Within 12 hours ? extreme nausea, chills, fatigue, body aches, mild arm soreness, mild shortness of breath 12-24 hours ? mild nausea, chills, fatigue, body aches, slight cough, more intense arm soreness at injection site
Fever, chills, feeling fluish, headache & pulse pounding in head, weakness, exhaustion, joint aches, ?foggy? headed (feel like thinking slower).
angioedema/swollen lips, fingers and toes and slight swelling of tongue; diffuse blanching maculopapular eruption/itchy raised rash /Rash was wide spread and there was a concentration on injection site; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration, administered in arm left at the age of 68 years old on 25Feb2021 18:00 at single dose for covid-19 immunization.  Medical history included high blood pressure, hashimotos thyroditis, eczema, osteopenia, hepatitis b, and allergies to penicillins, erythromycin nitrofuran analogues, oxycodone. Concomitant medications included metoprolol and hydrochlorothiazide. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient began to develop itchy raised rash on 05Mar2021, 8 days after 1st injection. Rash was wide spread and there was a concentration on injection site. Took Advil and Claritin and used cold packs. On morning of 08Mar2021 patient awoke to swollen lips, fingers and toes and slight swelling of tongue. Went to urgent care. Diagnosed with angioedema and diffuse blanching maculopapular eruption. Placed on steroid pack and cetirizine. Because of time lapse between injection and rash, the patient sought counseling on whether or not to proceed with second shot. Treatment Steroids and antihistamine were received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Event result in emergency room/department or urgent care. Events were reported as non-serious, no seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Sore arm, fatigue and general sick 12-24 hours after second dose.   Missed period with no pregnancy which is very irregular for me.
Arthralgia, malaise, localized redness, swelling L deltoid rash on upper body.  Patient took diclofenac 75mg q 12 hrs x3 days, TYLENOL PRN.
Exacerbated asthma for a week, beginning around 3 to 4 days after the second shot, culminating in an ER visit.   Prescribed COPD inhalers and monitored and was released.
An unspecified patient received a dose of MMRII via the intramuscular route on 9/16/2020; This spontaneous report has been recieved from a pharmacist concerning an approximately 30-year-old female patient of unknown ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 16-SEP-2020, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II) (dose regimen, batch/lot # and expiration date not reported) by intramuscular route (Incorrect route of product administration).
Case number PHEH2013US014762 is an initial spontaneous report received from a medical assistant on 09 Jul 2013. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. It was reported that on 09 Jul 2013 he was vaccinated only with MenCYW-135 liquid conjugate of MENVEO (batch number: X12025) intramuscularly and did not receive the MenA lyophilized conjugate. No adverse event was reported following the maladministration.
Throbbing, hot pain at injection site, went to urgent care 10/27/14, placed on anti-inflammatories, FU private MD 11/10 on MEDROL and anti-inflammatories. To FU early 2015.
Patient began experiencing a red circle around the injection site yesterday. Upon presenting to pharmacy the rash has expanded down the arm and encompasses the bicep area. The rash is hot to the touch with a slight itch, and aches when pressure is applied.
12 hours after injection- SVT event leading to heart palpitations, dizziness, SOB inability to walk, nose stuffy, severe headache for three days unrelieved by Motrin, ASA; severe muscle ache, chills, teeth chattering Fever from 97.4 at 7PM to 101 at midnight after injection Noted dx with SVT after first bout with Covid January 2020 received cardiac ablation 6/2020 and had no more episodes until this event directly related to effects of Covid Booster shot
2/25 Thursday night- itchy arm at injection site, small red circle. Very tired. 2/26 Friday night - still itchy at injection site, upper lip swelling/ allergic reaction, very tired.  2/27- still itchy at injection site, upper lip swollen and reacting on inside, hives starting on my face, arm, torso.  Will be contacting quick care next as my doctor office is closed.
Case number PHEH2017US001429, is an initial spontaneous report received from a nurse on 11 Jan 2017. This report refers to a female patient of an unspecified age. Prior vaccination history included as, patient vaccinated with FLUVIRIN vaccine and it was well tolerated. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618501 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 06 Jan 2017. It was reported that, FLUVIRIN MULTI DOSE vials (MDV) that reached 34.3 Fahrenheit for multiple excursions since 04 Jan 2017, was administered on 06 Jan 2017. It was reported that, patient was vaccinated with second flu shot with another flu vaccine. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse. Follow up reported received from a pharmacist on 02 Feb 2017: Added prior vaccination history and reporter comment.
First symptom noticed was N/V approximately 4 hours after vaccine administration, resolved after 6 hours.   Approximately 6 hours following administration pt experienced shaking chills, low grade fever with body aches and fatigue.  Approximately 9 hours post vaccination pt was noticing increased SOB with O2 sats which spouse states are usually mid 90's were reading low 90's.  These symptoms decreased after day 2-3, improved at one week.  Seen in OV 20 days following administration for fatigue.  Pt continues to experience increased SOB with exertion and decreased home oxygen saturation levels below typical baseline.  OV on 9/30/21 for symptoms indicates SpO2 reading of 93%.     Prior to third dose pt had reduced Cellcept from 1000 mg daily to 500 mg daily for 2 weeks prior and had returned to full dose of Cellcept 2 weeks following, per instructions from rheumatologist.    Spouse reports no other vaccine administrations or acute illnesses noticed in 1 month prior to vaccine administration.  Pt has OV scheduled with pulmonology on 10/20/21.  Spouse is instructed to seek emergency care if pt has worsening of SOB or SOB at rest.  Inform this RN if any other changes in recovery.  VAERS report to be submitted and updated as needed.  Spouse verbalized understanding.
Within 2 hours of vaccine, developed inconsolable crying, (R) thigh warmth and redness.
Patient experienced pain and redness day after injection. She was told this was normal. Then, swelling increased and injection site is still tender. Patient visited ER. She can't raise her left arm and can't move it to perform activities of daily living. She has not had fever and no recent signs of inflammation. Movement of upper limb affected--heading toward frozen shoulder per doctor. No dates for events available.
Staff member called a Health Office 3-16-2021 10:40am and reported since COVID-19 vaccine #2 on 1-29-2021 IM to left deltoid, she's had constant dull, aching pain level 3/10 to her left upper arm deltoid area. States pain occasionally radiates to left axilla, but never below her elbow. Denies redness or swelling. States pain relieved with over the counter Tylenol as needed. Has appointment with her doctor 3-16-2021 for evaluation of pain.
Arm was sore after receiving flu shot for a prolonged amount of time "joint pain"-not relieved by Ibuprofen.
Developed a rash and hives on arm on 9/14/22. Next day on 9/15/22 woke up with rash on arms and slight rash on cheeks. Later in the evening the rash got worse on cheeks and leg.
Pt recv vax on 1/6/99; on 1/10/99 pt exp fever (103F) & chicken pox-like rash; tx=Tylenol
long hauler COVID/ I am suffering from LHC and it is crippling; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long hauler COVID/ I am suffering from LHC and it is crippling) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (long hauler COVID/ I am suffering from LHC and it is crippling). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long hauler COVID/ I am suffering from LHC and it is crippling) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
Narrative: 79 year old MALE who presented for outpatient cardiac stress test, was noted with rapid heart rate of 140+. Transitioned to the ED, noted with atrial fibrillation and RVE, and febrile. Further testing shows Covid 19 positivity. Patient states he thought he wasn't suppose to eat or drink for 2 days prior to testing. Also hasn't taken his medications  for 2 days. ED tx includes diltiazem 10 mg\IV, metoprolol 5 mg IV times 3 with reasonable response. Patient became quite tachycardic in ED with movement and slightly winded. Placed on 3 LPM oxygen support in ED, also with acute on chronic renal failure. Patient was admitted to MICU overflow and downgraded next day. HOSPITAL COURSE: slow improvement in appetite, and overall comfort. Discharged home, to quarantine additional 8 days for COVID infection.
Woke up with a stiff neck; sore arm; sore arm at the injection; Started to get the chills; took temp was 99.5 neck getting worse; Feel achey; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 13:15 (Lot number: FC3182) as dose unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: verbatim- Diabetes; "Anyurism" (unspecified if ongoing), notes: verbatim-Anyurism; "Known allergy- Minerals" (unspecified if ongoing); "Covid-19", start date: Jan2021, stop date: Jan2021. Concomitant medication(s) included: FUROSEMIDE; OMEPRAZOLE; FAMOTIDINE; SYNJARDY. Past drug history included: Known allergy- cipro for drug hypersensitivity; Known allergy- srythromiacin for drug hypersensitivity; Known allergy- flexeril for drug hypersensitivity. The following information was reported: MUSCULO-SKELETAL STIFFNESS (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Woke up with a stiff neck"; PAIN IN EXTREMITY (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "sore arm"; VACCINATION SITE PAIN (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "sore arm at the injection"; CHILLS (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Started to get the chills"; PYREXIA (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "took temp was 99.5 neck getting worse"; MALAISE (non-serious) with onset 02Sep2021 09:00, outcome "not recovered", described as "Feel achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness, pain in extremity, vaccination site pain, chills, pyrexia, malaise.  Additional information: It was reported that patient felt fine after the shot. Woke up with a stiff neck and sore arm at the injection. Started to get the chills, took temp., was 99.5 neck getting worse. patient had Covid in Jan021. Feel achy. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Fever, NauseaVomiting, sore arm Headache, fever nausea, myalgia, arm soreness; antihistamine, tylenol, advil; Resolved.
Patient was administer an expired vaccine/ no AE; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Medical Information (MI) (Reference number- 00696834) and transmitted to Sanofi on 27-Jul-2021.  This case involves a patient (unknown age and unknown gender) reported that patient was administer an expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 21-Jul-2021, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number not reported, and expiry date 08-Jun-2021] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "Caller stated that ACT-HIB was administered to a patient on 7/21/2021 and expired on 6/8/2021. Caller would like to know what to do next and what side effects may be associated. Product used: Used".  It was a case of actual medication error due to expired vaccine used (latency 6 days).  At the time of reporting, patient had no adverse event.  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 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.  There will be no information available on the batch number for this case.
She got her vaccine in the left arm, and felt fine.  She went shopping in the store and noticed that she was short winded when she was leaving, but felt that it was possibly asthma and left.   She had a temperature between 102 and 103 for a couple of days and having fever and chills as well.  She continued with the shortness windedness, and had company and on 5/9/21 they left and she started having severe pain, felt like it was either on the right side kidney or the lung, and was spasming horribly and knocking her down with the pain.  She went to the ER and they did a CAT Scan thinking it was kidney stones, but told her that she had three blood clots in her lungs, lower base right and lower base left and mid right and part of her lung has apparently died due to this.  They put her on blood thinners, Xarelto.   She was admitted on 5/10 early morning and released on 5/12/21.  The doctor in the hospital said that it did not make sense that she had blood clots in her lungs, but nothing in her legs.  She told her that she was short winded, and he told her to report her reaction.  Since being home she has been coughing a lot due to possibly the blood clots.  She was told that she will be on the Xarelto for a very long time.  She was also informed that she had lymph node enlargement as well.
tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received the second singles immunization at a local pharmacy on August 8th. No reaction that evening. But by the next morning I had flu-like symptoms. These included nausea, headache, and intense joint pain. for most of that day. Also had a 3 - 3 1/2 inch red spot just beneath the injection site. Symptom lasted through the day, were lessened the next day and gone my the third day.
Eye and facial swelling; Eye and facial swelling; This is a spontaneous report from a contactable consumer (patient).   A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 07Mar2021 as FIRST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient previously took clindamycin and experienced drug hypersensitivity. On 07Mar2021 16:30, the patient experienced eye and facial swelling. The patient has not received any treatment for adverse events. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
has sensitivity to heat when she goes outside; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (has sensitivity to heat when she goes outside) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TEMPERATURE INTOLERANCE (has sensitivity to heat when she goes outside). At the time of the report, TEMPERATURE INTOLERANCE (has sensitivity to heat when she goes outside) outcome was unknown.            Treatment and concomitant product information was not provided.
pt recv vax in 1996 & 1APR97 pt exposed to varicella;3APR(7 & 8APR97 pt exp negative titers;
Patient describes tremors in bilateral arms beginning on 1/11/2021.   Patient first noticed tremors beginning in L arm where vaccine was given.  No fever, no trouble breathing, or headache related.  Patient says she had fatigue, pain at injection site, and diarrhea beginning on 1/8/2021  after receiving vaccine that has since subsided as of yesterday.
C/O dizziness, nausea, reflux, severe HA, can't stabilize self, had to be sent home from school, gave TYLENOL and laid down.
Multiple Bilateral PE's; DVT; Right Heart Strain; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Multiple Bilateral PE's) and DEEP VEIN THROMBOSIS (DVT) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Multiple Bilateral PE's) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant) and MYOCARDIAL STRAIN (Right Heart Strain). At the time of the report, PULMONARY EMBOLISM (Multiple Bilateral PE's), DEEP VEIN THROMBOSIS (DVT) and MYOCARDIAL STRAIN (Right Heart Strain) outcome was unknown.            No concomitant medications nor treatment information was provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
pt recv vax & p/4hr was noted to have gen hives, no pruritus, cough , wheezing, or SOB;mom did not call until 26hr later & was seen immed;