chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 03-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid started on 15May2022 and stopped on 20May2022 for COVID 19 Treatment. Paxlovid ''rebound'' of symptoms and positive antigen test result 1 week after last Paxlovid dose. On 27May2022, event started. No hospitalization prolonged.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
temp @ md office 103, pt shaking & vomiting; pt was vomiting unable to keep formula down; p/Advil was given to pt in MD office temp went down; pt began playing & was able to retain formula; 1/2 to 1 p/vax pt devel high fever, marked debilit
Both elbows joint pain started about 6 months after the vaccine and continues for three months to date. No known reason for the joint pain. started suddenly on both arms.
Patient received second vaccination early. First vaccination given 6/3, second on 6/18. Antibodies drawn which shows immune response.
Flublock with a shipping excursion was administered to a patient, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot, expiry date, route and administration site was unknown on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  The shipment was shipped on Wednesday but the package was not signed for 10:37 am today, the product was still cold to touch delivered this morning.  At the time of reporting, the 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.  Information on the batch number was requested.
Now has COVID; Now has COVID; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient now has COVID on an unspecified date after first dose.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unknown date. The clinical outcome of the event patient now has COVID was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced MYALGIA (Achy). At the time of the report, MYALGIA (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided    Reporter did not allow further contact
freezing to death; Chills; Fever; Headache; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I have mouth full of fever blisters; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 06Feb2021 (at the age of 78-years-old) at single dose for COVID-19 vaccination. Medical history included blood pressure and heart disorder. Concomitant medications included metoprolol succinate (TOPROL XL) for heart medicine and hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) for blood pressure. Historical vaccine included BNT162B2 for COVID-19 vaccination on an unknown date and had no problems with the first shot. On 06Feb2021, the patient experienced freezing to death; chills; fever; headache; was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; mouth full of fever blisters. Treatment for the events freezing to death, chills, headache, feeling bad, tired included acetaminophen (TYLENOL). The outcome of the events freezing to death, chills, headache, feeling bad, tired and mouth full of fever blisters was unknown. The outcome of the event fever was recovered in Feb2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
aseptic meningitis w/intracranial hemorrhage, sz; onset w/in 24 hrs p/vax; pt was healthy a/vax given; FH pos sz;
Tingling and pain within 30 minutes of injection to the tips of my fingers, across back to neck and right jaw.  I had chills, headache, nausea with vomiting  x1. Within 24 hrs, I developed a red area on right arm that runs from elbow to underarm down below my breast. My lymph nodes are also swollen along the red area. I started 400 mg Ibuprofen every 6 hrs for the first 48 hrs. I then transition to 500 mg  tylenol every 6-7 hrs.
approx 15mos p/vax pt exp fever, nasal congestion, & 1 spot. on 24feb99 pt presented w/rash of greater than 200 varicella like lesions. MD felt skin lesions, fever, & nasal congestion not related to vax
experiencing short pain in elbow (in the same arm got his shot),Feels like some one hit him; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (experiencing short pain in elbow (in the same arm got his shot),Feels like some one hit him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ARTHRALGIA (experiencing short pain in elbow (in the same arm got his shot),Feels like some one hit him). At the time of the report, ARTHRALGIA (experiencing short pain in elbow (in the same arm got his shot),Feels like some one hit him) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Heart went into atrial fibulation completely out of the blue, no prior issues,  no family history, no risk factors - the only possible difference was the vaccine (coming from a very pro vaccine family but this needs to be watched)
Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.
Information has been received from a physician concerning an 18 month old male who on 06 Jun 2006 was vaccinated with Varivax. On 18 Sep 2006, the patient experienced zoster which is a reactivation of chicken pox and developed a rash in the tummy area. The patient sought unspecified medical attention. As of 02 Oct 2006, the patient's outcome regarding the zoster which is a reactivation of chicken pox and developed a rash in the tummy area was unknown. Additional information has been requested.
Within 1 hour after vaccine was given, teen called back experiencing severe shaking chills, severe headache, nausea and vomiting. We brought her back into the office and observed her another hour. She was noted to have an oral temperature of 95 degrees F on arrival and shaking chills. After about 30 minutes of intermittent vomiting and shaking under a blanket her temperature had improved to 97 degrees F and vomiting subsided. She tolerated 600 mg ibuprofen. We monitored her another 30 min and she sated her headache was improving and she wished to go home to rest. Called mom back this afternoon: mom stated she rested a couple hours in bed and woke up feeling much better with no headache or nausea and normal temperature.
Right arm became swollen, tight, hot to touch - 11/4/08.  AM 11/5 arm was numb and tingling/area affected was entire right upper arm - lateral.
Chills, aches, sleeplessness, reduced REM sleep (4%), increased sleep respirations, fatigue.  Symptoms waned after 24 hours, and further again at 48 hours.  Unable to work for 2 days.
Adverse Event: Patient vomited in the car and developed generalized skin erythema. Treatment: Patient was brought back into the vet clinic, was monitored for 20 minutes under flow-by oxygen, and was given doses of Benedryl (IM), Dexamethasone SP (IM), and Cerenia (SQ) to address the reaction. Outcome: Skin erythema decreased after ~10 minutes after injections. No vomiting occurred during or after treatment. Patient vitals and mentation were normal the entirety of the treatment. Patient was okay to leave after the 20 minutes.
Shortness of Breath, B/P 70/42, Pulse 54, O2 sat 88%, slurred speech  IV started by ENT
patient presented with acute hypoxic respiratory failure r/t to CHF also . positive for covid, pt diuresed and stablized, pt was discharged to home to follow up with cardiology.
Sensation of numbness in hands and feet.  Chronic since day after vaccine.  Currently still present.  Neuro exam is normal.
Has firm nodule on left thigh with small papule surrounding in size from 0.5 cm -2cm in size, also several small papules around top of diaper area on back. One on left side and one on left side of face . 3 on left arm. no fever, good appetite, sleeping more than usual. Instructed to give Tylenol every 4 hours for 2 days and Benadryl every 8 hours.
Fever to 101 degrees for 2 days, 6 centimeter  warm and hard induration surrounding the vaccine site.  Upper arm very tender to palpation. Swollen and tender lymph nodes to neck and axilla. Patient also experiencing myalgia and weakness.
at 1105am T=98.1, R=16, c/o feeling as though she has mild rt. throat swelling, itchy throat and mucous starting to build up in her throat.  Denies tongue swelling or SOB.   Water given.  at 1108 reports that the sensation that her right throat was swollen has disappeared and she now has the same sensation on the left throat. Continues to deny SOB or tongue swelling.  at 1120 this RN having difficulty getting the BP machine to reading patient BP.  Left Forearm BP163/97, P=86, R=16 O2 sat = 98%.  At 1125 reports that her mild lt throat swelling remains the same.  Denies tongue swelling or SOB.  1142 reviewed with Physician who evaluated the patient and instructed her to take Benadryl once she gets home.  Instructed the patient that if her symptoms worsen she should go the ER or call 911 if symptoms life threatening.
Rash, face, chin, neck, back, shoulder, arm and jaws face; Pain at injection (right); Pain legs and feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain legs and feet), RASH (Rash, face, chin, neck, back, shoulder, arm and jaws face) and INJECTION SITE PAIN (Pain at injection (right)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031220A and 031220A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain legs and feet). On 16-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at injection (right)). On 24-Feb-2021, the patient experienced RASH (Rash, face, chin, neck, back, shoulder, arm and jaws face). On 21-Jan-2021, PAIN IN EXTREMITY (Pain legs and feet) had resolved. At the time of the report, RASH (Rash, face, chin, neck, back, shoulder, arm and jaws face) and INJECTION SITE PAIN (Pain at injection (right)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
After 2 Pfizer shots I got the Moderna as the booster at the time I got the shingles vax.  About 14 hours later I had a headache, body aches and a 100.6 fever. Two days later I had a runny nose only. On the third day (today) I was drenched in sweat when getting out of the shower.
Pt recv vax on 12/14/98; on 1/11/99 pt exp varicella rash
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with related case 2018SA266212 for other patient under 65. This case involves patient (age under 65 years, gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that patient under 65 was accidentally injected with Fluzone High dose. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
The patient had completed a Covid Janssen vaccine on 3/8/21. They presented to pharmacy and requested a Covid Pfizer vaccine. The previous vaccination was not disclosed and it was not noticed by the pharmacy. They were given a dose of Pfizer on 7/12/21.
At 2:57 PM S/P Moderna,, vaccination to right deltoid patient repots numbness to throat and lips and nose. denies difficulty breathing and swollowing. Lungs auscultated and clear lungs. Vital signs within normal range except bp elevated (150/90). Patient continues to report dry throat. Benadryl given as protocol 25 mg (0.5ml) at 3.55pm left deltoid. Patient was continued monitoring maintained. patient reported to live 8 minutes away from the facility so he was asked to call wife to be escorted home.  vitals signs were taken times four which were within normal limits.
I was absolutely fine throughout the day other than my left arm getting exceedingly sore, which I expected. I thought I would have go some adverse affect already so wasn't worried. When we went to bed at 9 I started getting chills and a fever of 101, 102F. I had my electric matress pad turned up to max and I wasn't even sweating but, was shaking with cold. The chill faded at 3am ish and now I just have a fever of about 100F
Associate returned 45 minutes after receiving the vaccine. She was flush and had already taken 8 puffs of her inhaler. Difficulty breathing. Given two doses of orally Benadryl 25 mg each. Taken to the ER. Stated, She did not take her oral steroid that morning per patient
No symptoms upon patient leaving the clinic. She waited for 15 minutes post administration before leaving the clinic.
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 13:00 as dose 1, single (Lot number: En6205), in right arm and on 27Apr2022 at 13:00 as dose 2, single (Lot number: En6207) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Infertility" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: AIRBORNE ELDERBERRY, start date: 07May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Following my third dose of Paxlovid I began experiencing night terrors anytime I napped or slept in the evening. I have not had any prior experience with night terrors in my adult life. They were vivid and disturbing dreams. In addition since my first dose of Paxlovid I have had a grapefruit/ bitter soap taste in my mouth and mucus.  No follow-up attempts are possible. No further information is expected.
nasal congestion; burning sensation in eye; sore throat; chills; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), EYE IRRITATION (burning sensation in eye), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and MYALGIA (body ache) in a 67-year-old female patient 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue). On 31-Jan-2021, the patient experienced NASAL CONGESTION (nasal congestion), EYE IRRITATION (burning sensation in eye) and OROPHARYNGEAL PAIN (sore throat). On 31-Jan-2021, CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue) had resolved. At the time of the report, NASAL CONGESTION (nasal congestion), EYE IRRITATION (burning sensation in eye) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.            Treatment details included Steroid Eye Drops.  Concomitant medication was not provided by reporter.
Client received her second dose of the Pfizer vaccine at approximately 1835, five minutes later she started with fatigue and left sided chest pain, rated 6/10 on the pain scale. The client reported that the pain took her breath away and was noted on both palpation and inspiration. Client was oriented X3. HR 80 bpm and respirations 28. No history of allergy, not on any medications, and not pregnant or breastfeeding. Client was transported by EMS to local hospital.
Post Flu Vaccine. Superficial burning to outer left arm after 5 days developed into blistery rash on the top of the arm. Diagnosed as Shingles, currently taking Valtrex.
Reported temps of 101-102 for 24 hours. Severe body aches to the point where she can barely move.  Made an appointment to be seen by the PA.
Patient experienced severe chills and elevated fever lasting several hours (~3).  Chills caused uncontrollable shaking.  Patient decided to take a dose of aspirin the next morning to help with symptoms at which time his fever had already dropped.
Initial misuse report received from a healthcare professional on 19 April 2013. DAPTACEL was given to an 11 year old child. No adverse event was reported. List of documents held by sender: none.
Injection Site Pain, Headache, and chills. Using Antipyretics. Left work. Symptoms subsiding on day 2 of injection
RN was in exam room administering vaccines and called out for this RN to come help. When I came in the room she reported after flu vaccine was given the patient went a little stiff and her eyes rolled back. No LOC and patient was speaking when I entered the room but she did appear pale. Elevated patient legs. PCP notified and came to room to assess patient. Patient endorsed anxiety stating shots are her "biggest fear" and mom mentioned patient has a history of passing out with vaccines. Initial BP 107/61, HR 64, SpO2 98%. Patient given water and snack. She verbalized feeling better and was up to getting second vaccine which she tolerated well. Vital signs after second vaccine stable with BP 98/47, HR 71. Patient remained for RN observation 15 minutes after second vaccine was administered with no further adverse reaction.