chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within less than 10 minutes, post vax, the pt had an adverse reaction. The reaction involved an area of redness, measuring 4cm X 6cm with a 1.5cm X 1.5cm wheal, at the injection site. The pt also had redness on her chest and back. She was kept in the doctor's office for 1 hour to observe.
irritated rash that lasted about 1 & 1/2 weeks-required no treatment
Warm to the touch at the site of injection; A rash at the site of injection; Itchy at the site of injection; Red at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE RASH (A rash at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE RASH (A rash at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE RASH (A rash at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment taken.
Case number PHEH2013US015622 is an initial spontaneous report received from a pharmacist on 22 Jul 2013. This report refers to an adult male patient. While preparing MENVEO (batch number: A12009), a drop of the vaccine splashed in his eyes on 22 Jul 2013. No adverse event was reported following this administration error.
On 10/27/21 developed significant HA that continued through 10/31 when lesions began breaking out all over body.
10 days after booster, I woke up itching everyone on my body. Over the next few days I had outbreaks everywhere including my chest, torso, arms, back, face, feet, and hands. Rashes on my hands and feet began to feel bruised and made it difficult to walk. Rashes appear with pressure, scratches, light brushing of clothes, water (hot or cold) and seem to migrate. Each rash lasts for about 30-60 minutes. Joints are also sore and I am fatigued overall. I have been taking Zyrtec (20-30 mg daily), pepcid on some days, using hydrocortizone cream.
This non-serious spontaneous case, initially received from other health professional (nurse) on 07-Oct-2018, concerning a 3-year-old, female child patient. On 07-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc [batch number: 252230, expiry date: 30-Jun-2019, dose, route of administration and anatomical location: not reported]. At the time of this report, no adverse event were reported after the vaccination. Follow-up report received on 30-Oct-2018: The expiry date of the suspect vaccine was changed from 30-Jun-2015 to 30-Jun-2019 in the product tab. Hence, the previously coded event 'expired vaccine used' was deleted from the event tab. The narrative and case comment were amended accordingly.
Blisters  appeared right arm,  palm and in between fingers 3 days after receiving vaccine. Patient reports blisters as painful, itchy,  used some OTC  cream to help with itchiness.
Myalgia, Fever, extreme fatigue and "fogginess" Narrative: Emp started with soreness at sight and shoulder at 9pm day of vaccine 03/26/21. During the night he had a fever of 99. Took Ibuprofen 800mg and woke up with fever of 101.2.  on3/27. 03/28 had extreme fatigue, no longer had fever and felt a "fogginess" Rested and improved by 03/27 although still felt fatigued.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved do for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Chills, headache, vomiting, burning with urination, dizzy spells, tremors. Onset 11 hours post injection lasting 24 hours, felt fine for a day, then very sick with hallucinations 72 hours after vaccine.
Pt called from store reporting muscle spasm and diffuculty breathing after 6 hours of flu vaccine administration.  Instructed pt to call 911.  Pt was contacted same day and next and told me that this kind of episode happened to him about 3 times before.  Not sure if flu vaccine triggered this episode.  MD at ER gave him robaxin and naprosyn on discharge.
Upon giving the flu shot to the child, the child moved his arm while administering, so some of the liquid came out and some are still left in the syringe. Approximately half the dose was given. Thus, another half dose will be given at same day but needed to get clearance from division and patient care pharmacist to ensure that is the right thing to do.
mom reports dime size hard knot on rt legs appeared p/vax;still present following tuesday;
headache; feaver; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) and PYREXIA (feaver) 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 HEADACHE (headache) and PYREXIA (feaver). At the time of the report, HEADACHE (headache) and PYREXIA (feaver) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
12 days after receiving my first booster shot, I developed significant stiffness, pain and decreased strength and range of motion in my right hand. I woke up that evening and on making a fist, my pinky locked and clicked when it did bend. My right hand was very stiff and sore (4/10). These symptoms have continued and are still present. I have decreased strength and range of motion in the right hand daily and extreme stiffness with pain after inactivity (at night or after naps). I had no arthritic symptoms prior to this and symptoms are not getting better. I have slight stiffness in left hand.
104F fever, within 24 hours. Rash, within 48 hours. Was seen on 5/18/01 and dx'd with bilateral ear infections.
5cmx6cm red area; 1cmx2cm hard, indurated area on right thigh 24 hours post vaccination.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 13-FEB-2015 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose was unknown) for intramuscularly which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Pt started with pain and weakness in the (L) arm the evening of 4/25/16, which progressed to significant fatigue and generalized muscle pains. Mom reports symptoms are worse today.
pt not immune to chickenpox (by titer) given varivax 11JAN99 devel chickenpox +cult form vesicle on 27JAN99;
Left mid-thigh swelling to below left knee, fever, pain with flexion of knee (increasing over a 24 hour period). (+) blood culture at 10 hours for pneumococcus. Further serotyping identified it as 23F. IV antibiotics given for 10 day course. Diagnosed with prepatellar cellulitis
16-year old pregnant female received Moderna covid - 19 vaccine. No adverse reaction reported so far.
Pt was given a Tdap in the emergency room on 6/18/2008 for a horse bite.
I'm having an itch, arm is feeling hot, and have a lump all on my right arm.
Information has been received from a consumer concerning her 7-year-old daughter with no pertinent medical history and no drug reactions/allergies who on 11-SEP-2007 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included hepatitis A vaccine (inactive) (MSD). On 25-SEP-2007, two weeks later, the patient broke out in a rash. The rash was diagnosed as the chickenpox. A "test for chickenpox" was obtained. The outcome was recovering. Medical attention was sought. There was no product quality complaint. Follow up information from the physician indicated that there was no additional information available. Current patient status was no reported. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L018500, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I have developed intermittent scintillating scotomas and loss of visual field, occurring 2-3 times weekly. This symptom is very rarely associated with mild generalized headache and facial numbness, and have been tentatively diagnosed as visual migraines, pending full neurology workup. In my lifetime, I have previously had 3 migraines which were accompanied by a visual aura. Two of these occurred while pregnant (one with each pregnancy) and one additional episode occurred in approximately 2017. These events were different than what I am currently experiencing. I am unsure if this is vaccine related, but felt it should be reported, just in case others are experiencing similar symptoms.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 20-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was age 16 years when received Moderna vaccine, which is not recommended for persons under the age of 18.  Mother states she spoke with provider about this, and he told her "I think we are close enough it will be ok". Mother allowed patient to receive vaccine. For the following week patient c/o shortness of breath, Rapid heart rate, and sore throat. Mother brought patient back into clinic and was seen by a different provider, and was given a antibiotic therapy.  Mother states after finishing the antibiotic, patient recovered well.
VAR administered 12-20-11 in right deltoid subcutaneous. Anterior deltoid 1 cm area of mild redness and induration around injection site, warm and tender to touch. Distal to site there was a line of hyperpigmented skin.
Upon injection, felt needle and vaccine enter her arm. Soreness and pain from shoulder to elbow. Numb, dull ache continues during the day. Minimal relief with ibuprofen during the day and TYLENOL PM at night. Unable to sleep on either side. Pain 6 during day and 10 during night on 1-10 scale.
On day of vaccination, he developed tactile fever, chills, headaches, body aches, and mild nausea without emesis. The next day, he took ibuprofen with mild relief of his symptoms. On day of presentation, the patient was riding an armored vehicle and developed headache and chest discomfort.  On admission, treated with colchicine and Motrin.
Stinging pain when injected. Swelling at injection site--hard bump about size of an egg. Redness. Soreness. Swollen lymph nodes under left arm and in neck
Started with body chills, headache, temp 102.8, nausea. Headache lasted 24 hours. Next day when temp went down started to have swelling in her R arm not where vaccines given, lower towards her bicep. Called Dr. office and spoke with nurse for Dr. who reported typical reaction in arm and to call back if worse.  By Friday arm was twice the size, redness and hot to touch. Seen by PCP who did not think it was cellulitis, took pt she received 2 unnecessary vaccines and was not happy about pt receiving Flu and Pneumovax 23 in same right deltoid. Was told to take Benadryl and use ice packs. Pt unhappy with PCP response. She called allergist office and spoke with nurse. Not sure this is new allergy to eggs, pt reports eats eggs daily. Recommended that pt receive flu shot be given by allergist next year.  Not sure if this is a true reaction to flu shot.  Pt reports 20 years ago she had reaction to first flu shot, was dizzy for 3 days.  Has had flu shot almost every year since and no problems.  Pt will follow up with allergist.
Information has been received from a health professional concerning now an approximately 4 year old male who on 05/19/1998 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that in the spring 2001, in approx. May, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Information has been received from a physician concerning a 12 year old female with no pertinent medical history, no known allergies or drug reactions, who on 01-OCT-2008 was vaccinated with the first dose of GARDASIL IM.  Concomitant therapy included VARIVAX (route and site not reported).  On 01-OCT-2008 the patient experienced syncope.  The patient was exiting the office and fainted hitting her head.  On 20-OCT-2008, the patient recovered.  A computed axial tomography was performed (results not reported).  Additional information has been requested.
Narrative:  Discussed plan with ED physician regarding instructions for patient. Patient is to quarantine for at least 10 days. Wife instructed to pick up pulse oximetry machine from ED; since they live a long distance from the facility wife will purchase 1 at store. Instructed wife to conduct pulse ox test on patient multiple times per day especially after rest or when waking up or if having dyspnea. If pulse ox is 94% or less , patient should report to ED. Exposed family members may get swabbed in 3 to 5 days to prevent false negative result unless symptomatic in which case they should seek medical attention. Patient's wife understands and questions were answered to her satisfaction.
PATIENT PRESENTED TO PHARMACY WITH 6 INCH ROUND RED SWOLLEN AREA ACCOMPANIED WITH ITCHING, BURNING AND REDNESS CONTINUING AROUND THE ARM. SHE SAID IT FELT RAW.
Starting 24 hours after second dose, patient experienced fever, chills, body aches, headaches throughout Thursday and Friday.  On Saturday, she noticed a little 'movable lump' on her lower right jaw (opposite side from vaccine site).  By Monday the lump had grown to 3.5cm. That day she saw a doctor who examined her and was uncertain if it was due to a vaccine. A CBC taken that day was completely normal. Nothing was prescribed.  Since Monday, the lump is hard but slightly tender and sometimes warm to the touch, but it has been getting smaller. Patient notes her temperature has been slightly higher than normal for her (~98.3') but otherwise she feels fine and the lump does not impede her swallowing, breathing, or talking.
Vaccine side effects; 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 VACCINATION COMPLICATION (Vaccine side effects) in a 31-year-old patient of an unknown 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 VACCINATION COMPLICATION (Vaccine side effects). At the time of the report, VACCINATION COMPLICATION (Vaccine side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a pharmacist refers to a female patient. On date of this report (24-JAN-2014) the patient was 72 years old. No information regarding the patient's medical history was provided. It was reported that on an unspecified date the patient may have received the first dose of PNEUMOVAX23 injection. Route was not reported. No concomitant medication was reported. On 24-JAN-2014 the patient came to the pharmacy for her second injection. No vaccine was administered. No adverse effects were reported. No outcome was reported. Additional information has been requested.
a 10 years old patient had been vaccinated with vaccine which was shipped on May 22 and received May 28, too long in transit/No AE; Initial and additional information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA156956 (sibling).  This case involves a 10 years old male who was vaccinated with a 0.5ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] which was shipped on 22-May-2019 and received on 28-May-2019, vaccine was too long in transit (lot P2A89, Expiration Date: 14-Sep-2020) via unknown route in unknown administration site on 30-May-2019.  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. It was reported that vaccine was only packed for 2 day shipping and it was 5 days.  Patient did not have any adverse events at the time of reporting.  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.
2nd stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 at 16:00 as dose 2, single (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, SINGLE, Batch/Lot No: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 09Mar2021, for COVID-19 immunization, reaction(s): "Had 1st stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 31Mar2021, outcome "recovered with sequelae", described as "2nd stroke". The patient was hospitalized for cerebrovascular accident (start date: 31Mar2021, discharge date: Apr2021, hospitalization duration: 4 day(s)). The event "2nd stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; (Jan2023) Negative. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: Patient had 2nd stroke on 31Mar2021. Went to Regional Emergency Room. Was advised of stroke, given medicines, then transported via ambulance to hospital and was admitted for 4 days. Everyone denied that the vaccine had anything to do with it and didn't even want to discuss it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143276 same vaccine/patient, different dose/event (Dose 1);US-PFIZER INC-202300145920 same vaccine/patient, different dose/event;
Sore arm; Low fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, PYREXIA, and FATIGUE in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY, PYREXIA, and FATIGUE. On 09-Feb-2021, PAIN IN EXTREMITY, PYREXIA, and FATIGUE had resolved.            No concomitant medication was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-403266, MOD-2021-403257 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age. Patient's concurrent condition, pertinent medical history, drug reactions and allergies were not reported. On 14-AUG-2017, the patient was vaccinated with an expired dose of PROQUAD (lot # M006103, expiry date: 01-AUG-2017) subcutaneously for prophylaxis (expired product administered). Dosing details were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). It was reported that no temperature excursion occurred for this dose of PROQUAD. No adverse effects reported. No product quality complaint (PQC) was involved. No additional information was provided.
This case was reported by a physician and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (Pfizer) given on 19 September 2011. Concurrent medications included BENADRYL. On 19 September 2011 at 10:00 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left leg. On 19 September 2011 (14:00), 4 hours after vaccination with PEDIARIX, the subject experienced fever. On the morning of 20 September 2011, one day following vaccination with PEDIARIX the subject developed a rash. The physician considered the events were clinically significant (or requiring intervention). It was noted that the subject required multiple visits to the physician's office. Fever resolved 3 days after onset on 21 September 2011 and rash resolved 3 days after onset on 22 September 2011. Attribution of the events to vaccination with PEDIARIX was not reported.
Pain on right side of body to include shoulder, neck, base of head right side, pressure behind right eye. Symptoms began around noon that day and continued until 7:00 pm.
The day after receiving the shot, I became very ill with fever, chills, nausea and somewhat disoriented.  It lasted about 3 days.  Took tylenol and unable to go about daily routine.  Had to let it run its course.  Contacted doctor by phone.  After the third day, I had severe sweating for at least 12 hours.  It took a while for me to get my strength back again, real weak and tired.