chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site pain; swelling at injection site; injection site redness; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   The reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The age at vaccination was not applicable for this report. The nurse ordered to administer a dose of Bexsero among other vaccines. She mentioned that she has had multiple adverse events regarding Bexsero with the classification of pain, redness and swelling to the injection site for about a week. The reporter mentioned that this reaction was more severe than other vaccines she administers. When asked about reporting, she stated that she has reported some cases and not reported some and did not have the paperwork anyway. The nurse had been made aware that the safety team would put this as a general adverse event in with her team and if needed they would reach out to her. The nurse had been informed to shake the syringe while use and referred the prescribing information regarding to the pain, redness, and swelling. The nurse agreed to be followed up.
pt recvd vax 21oct at 1pm; 4-8pm pt irritable crying; pale except redness under neck & by diapers; sweating; mom said pt "like a rag" went to er; P124 RR56;resting quietly, pink, skin warm & dry
Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Information has been received from a consumer, the mother, concerning her nine year old son who in 1995 was vaccinated with a dose of varicella virus vaccine live. The reporter stated recently her son was "exposed" to someone with chickenpox, and broke out in doctor diagnosed "mild case of chickenpox on 22-MAR-2003". It was reported there was no fever. The reporter declined to give demographics or physician information.
Back pain, left arm pain a day or two later, right arm pain a day or two later, thigh pain in front with occasional cramp in back of thigh, hip pain. All continued for days after and finally patient went to the doctor. Said muscles in legs were tight and gave patient muscle relaxers (Naprosen) and pain pills (Cyclobenzaprine). These did not work. Went to hospital ER on 10/23/2001. Blood work and X-rays were conducted. Blood work showed nothing, but doctors concluded patient had Lumbosacral Radiculopathy. Put on Prednisone and Vicodin. Pain was alleviated with the Prednisone until patient was slowly weaned off (2 weeks). Patient made an appointment with Spine doctor for Nov 18, but had so much pain decided to go to another Medical Aid Unit for another opinion and the doctor diagnosed patient with PMR (Polymyalgia Rheumatic). Sent for blood work and results of Sed Rate were 44 and C reactive protein were 33.8. Patient now on Prednisone once again.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot # K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Large, circular, raised, red area; Large, circular, raised, red area; Hurts if accidentally hit arm; Itches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 11Sep2021 at 14:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, severe allergies and allergy to gold. 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-19 vaccine. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ascorbic acid (VIT C), ganoderma lucidum (REISHI MUSHROOM), beclometasone dipropionate (QVAR), zinc (MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 21Aug2021 at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, the patient experienced large, circular, raised, red area and 56 plus hours post injection and had not subsided. The area itched and hurt the patient if she accidently hit her arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large, circular, raised, red area; itches and hurts if accidentally hit arm was not resolved at the time of the report.
Local redness, swelling and pain at site of injection, Treated with diphenhydramine and ibuprofen by mouth once.
Injection site pain, redness, swelling, bruising, itching, warm to the touch. Rash continued to grow from the injection site 9 days following the vaccine.  Measured 9 inches by 4 inches.  Nurse Practitioner prescribed Keflex 3 times daily.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unspecified date, the patient was inadvertently vaccinated with a fourth dose of GARDASIL (lot number, expired date, dose, frequency and route were known). Concomitant therapy was not reported. No adverse effects was reported. Additional information has been requested.
Started with right hand becoming extremely cold and cold objects felt like they were burning. Night time led to numbing upper and lower extremities. Muscle spasms in calfs and lower/upperbody weakness. Sensation of vibration then numbness. At day 11,had to go to the emergency room due to temporary paralysis ..treated with atavan for 5 days.next week,same numb episodes at night and while napping,led to appointment with neurologist after a second trip to the E.R where they took blood and MRI. Neurologist  prescribed gabapentin which made matters worse. Waiting currently for EMG test
Raised hives like rash; Extremely itchy rash; Injection site is itchy; Injection site redness (4inch diameter); Injection site is raised; Injection site has a rash; Injection site is warm to the touch; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)), RASH PRURITIC (Extremely itchy rash) and URTICARIA (Raised hives like rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy, Allergy to metals and Atrial fibrillation. Concomitant products included METOPROLOL for Atrial fibrillation, ROSUVASTATIN from 10-May-2020 to 06-Feb-2021 for Cholesterol, ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills). On 13-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)), VACCINATION SITE SWELLING (Injection site is raised) and VACCINATION SITE RASH (Injection site has a rash). On an unknown date, the patient experienced RASH PRURITIC (Extremely itchy rash) and URTICARIA (Raised hives like rash). On 28-Feb-2021, CHILLS (chills) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), RASH PRURITIC (Extremely itchy rash), URTICARIA (Raised hives like rash) and VACCINATION SITE RASH (Injection site has a rash) had not resolved and INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)) and VACCINATION SITE SWELLING (Injection site is raised) outcome was unknown.            No treatment medication details was reported. action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27 May 2021 included: Updated reporter address and email. On 28-Jul-2021: Event added itchy rash, age updated,events outcome changed.
Patient vaccinated 4/28/2021, 4/7/2021. Hospitalized COVID positive 12/29/21.
fever; was tired/fatigue; second dose was 14 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was 14 days after the first dose), PYREXIA (fever) and FATIGUE (was tired/fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was 14 days after the first dose). On 31-May-2021, the patient experienced PYREXIA (fever) and FATIGUE (was tired/fatigue). The patient was treated with PARACETAMOL (TYLENOL) on 31-May-2021 for Fever and Tiredness, at an unspecified dose and frequency. On 30-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was 14 days after the first dose) had resolved. At the time of the report, PYREXIA (fever) and FATIGUE (was tired/fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Safety follow up consent was obtained.
i have a 101 fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th January 2021, the patient received the 2nd dose of Shingrix. On 21st January 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient got the 2nd shot last night from the day of reporting. They took temperature and it was normal.  The patient got the shot and now at the time of reporting had a 101 degree Fahrenheit fever.  The patient did not have this kind of a reaction to the 1st shot.  The patient how long could expect the side effects to last.
Within hours eyes became infected, visited urgent care a few times, fatigues, bruising developed over 2/3rd of body, visited PCP, for blood work, referred to hematology/oncology for additional blood work, testing for autoimmune disorder, lupus, etc.  due to vax triggered return of seizures, bruising continues to increase and decrease, never went back for 3rd injection due to adverse events. Developed breathing issues, pneumomediastinum, nodule on lung Dec 2017, admitted to hospital. All future vax are refused and repeated harm is being noted from any and all vax. Immune system is being destroyed and DNA is being manipulated. Informed Consent is the lawful approach for humanity!
Had the MENACTRA vaccine on 4/2/2018, puffy around one eye on 4/3/2018. Rash appeared on 4/4/2018. Took son to his pediatrician 4/5/2018 where they gave him a prescription of Triamcinolone Acetonide. That evening child said he had pain all over. Went to Emergency Room that night. He was given a prescription for Prednisolone.  He is currently still using the Triamcinolone and Benadryl.
Dose #1- Within 10 minutes of injection, heart racing, wave of warmth from injection site to face, change in taste to metal taste. 7 hours post injection-Woke up with burning eyes, stomach upset, nausea, and diarrhea. 48 hours post injection-Swelling, redness joint pain in index finger on right hand. Brain fog and fatigue for 5 days post dose#1. Dose #2 10 days post injection (1/22/21 @ 0935), standing in kitchen, felt tingling in back of neck and into head, heart racing, pulse oximeter read heart rate fluctuating in 130's. Scheduled an appointment that morning with primary care, per Dr. notes EKG shows possible sinus arrhythmia, Holter monitor ordered Sinus tachycardia.  Continued symptoms of dehydration, daily headaches for 2 months post dose #2. Results from Holter after 2 weeks.-Symptoms corresponded to sinus tachycardia. Stopped all caffeine, increased water substantially. Heart rate slowly subsided over 5-6 months. 1 PVC noted. Dose #1 Within 10 minutes of injection, heart racing, wave of warmth from injection site to face, change in taste to metal taste. 7 hours post injection-Woke up with burning eyes, stomach upset, nausea and diarrhea. 48 hours post injection-Swelling, redness joint pain in index finger on right hand. Brain fog and fatigue for 5 days post dose#1. Dose #2 10 days post injection (1/22/21 @ 0935), standing in kitchen, felt tingling in back of neck and into head, heart racing, pulse oximeter read heart rate fluctuating in 130's.  Scheduled an appointment that morning with primary care, per Dr. notes EKG shows possible sinus arrhythmia, Holter monitor ordered Sinus tachycardia. 1 PVC noted. Continued symptoms of dehydration, daily dehydration type headaches for 2 months post dose #2 and continued zapping like headaches in left temple for 11 months post dose #2 and brain fog intermittent for 11 months post dose #2. Results from Holter after 2 weeks.-Symptoms corresponded to sinus tachycardia. Stopped all caffeine, increased water substantially. Cardiologist visit diagnosed Sinus Tachycardia. When attempt to discuss concerns of this being related to vaccine, it was brushed aside. Heart rate slowly subsided over 5-6 months. Became pregnant 6/2/21, miscarried 7/12/21, continued with complications and had dilation and curettage and laparoscopy procedure due to suspected remnants remaining in uterus or ectopic. Partial fallopian tube removal due to suspected ectopic. Found that fibroids had enlarged significantly likely the cause of tube blockage.
A non-serious spontaneous report of sprayed in her eye while being administered was received from a consumer concerning a four-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The mother reported that her daughter received FLUMIST and it got spread in her eye while being administered. On 24-Oct-2010, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
gross hematuria for 3days, started ~2-3d after receiving the 2nd dose
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving nasal FLUMIST Quadrivalent 0.2 Millilitres. It was reported that FLUMIST Quadrivalent was refrigerated at 47 degrees Fahrenheit since 01-OCT-2015 which started on 01-Oct-2015. FLUMIST Quadrivalent (Intranasal) was discontinued during Oct-2015. The outcome of the event of FLUMIST QUADRIVALENT was refrigerated at 47 degrees Fahrenheit is unknown. The report was considered to be non-serious.
Pt received first moderna booster 03/31/2022 and second booster today 07/22/2022 (9 days early).  Pt monitored 15 min, no reaction noted.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a registered nurse concerning a 21-year-old male. The product expired on 05-Jan-2010. On 25-Jan-2010 the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Pt. got shot Friday 6-13-08.  Saturday am mom noticed redness, Saturday evening took her to ER, was given pain meds & sent home.  Sunday noticed it had gotten worse, went back to ER, gave her SEPTRA.  When pt. went to clinic it was better at 7 cm, now arm is better.  Spot almost gone.
The upper lip was slightly swollen and tingled.; The upper lip was slightly swollen and tingled.; The gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue.; The gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue.; This is a spontaneous report from a non-contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in arm left on 27May2021 at 10:00 as single dose for COVID-19 immunisation. Medical history included hypothyroidism (diagnosed 3 years ago, but not longer require meds) and was allergic to erythromycin, Keflex and sulfa. The patient's concomitant medications included One a Day Brand Multi Vitamin received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27May2021 at 15:00, the patient experienced the upper lip was slightly swollen and tingled and "the gum area above upper teeth and the inside of the top lip were bright red, inflamed, and the had a weird texture when I touched it with my tongue". The patient did not received any treatment for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
I noticed a sore throat that lasted 3 days.  After that I developed body aches, cough and congestion lasting about 3 days.  2/19 Took and At Home COVID-19 test, positive.  Televisit with doctor who proscribed Paxlovid.  Symptoms stayed the same for about 2 days after starting Paxlovid, and then things began to improve but still have lingering fatigue.
pt had intermittent asthma;treated 5NOV96 for bronchitis w/lorabid;treated 6JAN97 for inc wheeze w/albuterol;p/vax required pred despite rx & use of zyrlo;
Very fast pulse, chills, teeth chattering from 8:00 pm to 12:30 am
The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I thought it could be in my head. Throughout the evening after my shot I felt a bit of contracting of leg muscles and neck/shoulder muscles on the left side of my body. The left side of my face felt noticeably warmer than the right. This was all very mild, but just noticeable. In the middle of the night, I woke up with extreme night sweats but only on the left side of my body. The next morning (today) the left side of my face is still warmer but it feels droopy and bloated and slightly "Numbish". My left eyelid feels heavy. My left cheeks feel swollen and puffy and my left gums and lips feel slightly numb. I also have a very mild headache only on the left side. This is disturbing, while it is not debilitating or painful, it is strange and makes me think I should not get the next shot. Even as I type this, my left hand feels very fatigued. I don't know who to call or talk to about this. I do not have a health care provider.
Even though FDA approved Pfizer vaccine for 12-15 year patients at the time of administration. This patient (15y/o 3 month) received the pfizer vaccines 1 day before CDC /our company protocol approved its use in 12-15 year population. The parents incorrectly entered his birthdate online to make him eligible for the vaccine. Patient reported no side effects during 15 mins watch time
adult received Hiberix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old female patient who received Hib (Hiberix) (batch number 9X2TS, expiry date 30-DEC-2023) for prophylaxis.   In DEC-2022, the patient received the 1st dose of Hiberix. In DEC-2022, an unknown time after receiving Hiberix, the patient experienced inappropriate age at vaccine administration (Verbatim: adult received Hiberix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The pharmacy manager called in to ask for information about the possibility of administering Hiberix to an immunocompromised patient who received first dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. An adult patient received Hiberix which led to inappropriate age at vaccine administration.
Cellulitis Right Axillary Fold and Pain. Patient started on a 10 day course of Bactrim.  And to return to see Pediatrician on October 13, 2016. At this time the plan was to continue and finish current treatment and to shower twice a day. And to return if no improvement or sxs worsen.