chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product dose omission; Difficulty breathing; Loss of voice; Swelling of throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 66-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 reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), APHONIA (Loss of voice) and PHARYNGEAL SWELLING (Swelling of throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Product dose omission). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing), APHONIA (Loss of voice) and PHARYNGEAL SWELLING (Swelling of throat) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  This is a report of a 66-years female, whose medical history and medications were not provided; who presented an immediate reaction after receiving the first dose of the product.  As per medical judgment are not considered life-threatening; thus, as this is a SPONTANEOUS REPORT, seriousness has manually been overridden.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, for the event Product dose omission issue of mRNA-1273, causality is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, for the event Product dose omission issue of mRNA-1273, causality is not applicable.
BILATERAL SWOLLEN LYMPH NODES IN NECK AREA; FLU LIKE SYMPTOMS; BODY ACHES; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 176 pounds, and height was 64 inches. The patient's past medical history included diabetes type 2, clotting disorder, patent foramen ovale, two heart murmur,, surgery on right knee, hyperlipidemia, hypothyroidism, stroke, htn, and pacemaker, and concurrent conditions included allergic to phenergan, allergic rash due to penicillin, non-alcohol user, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage misarrange placental artery clotted.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced bilateral swollen lymph nodes in neck area. On 06-APR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral swollen lymph nodes in neck area, flu like symptoms and body aches was not reported. This report was non-serious.
Patient was seen in the office on 12/29/21 for Left Arm Pain, gradual onset.  1st Symptoms Began: 9/2021 after tetanus vaccine  Cause of Pain: pain in his L deltoid after the tetanus shot.  Over time the pain has increased and the ROM has been going down.  Cannot abduct much over 90 degrees on the L due to getting stuck and pain.  Has good use of the arm down low.  No weakness.  No numbness.  No swelling.  ROM down over the past month.   Progression: worsening Treatments:  Ibuprofen, tylenol.                                                      Effective: not at all effective Patient was diagnosed with adhesive capsulitis and given a handout regarding home care, prescribed meloxicam 15 mg, an xray of the left shoulder was ordered and patient was referred to orthopedics for evaluation and further treatment. Patient was seen by Orthopedics, Doctor on 2/2/22.  That physician ordered a left shoulder joint arthrocentisis.  Their visit notes were as follows: Patient is a very pleasant 43-year-old male here for evaluation of left shoulder pain.  He reports ongoing left shoulder pain after receiving his tetanus vaccine in September of 2021. He did not notice anything unusual about the injection other than the post injection soreness that he typically has.  Unfortunately that soreness continued to evolve and was eventually associated with decreased range of motion.  He was seen by his primary care suspected adhesive capsulitis and was referred to our office today for further evaluation.  On physical exam he does have restricted active and passive range of motion.  Abduction is approximately to 80°.  Flexion is approximately to 140° internal rotation is to L 3. He has good strength with rotator cuff testing.  I do not appreciate any discomfort or pain with any rotator cuff testing.  X-rays were obtained.  No acute osseous pathology noted.  Overall I do agree he is struggling with adhesive capsulitis.  I do question whether this is a adverse effect of his vaccination.  He was not having any pain or issues prior to the injection.  I did discuss with him the pathophysiology of adhesive capsulitis, the freezing frozen and thawing stages as well as the typical recovery.  Almost these cases to get better on their own we did discuss the typical recovery time can be anywhere from 6 months to a 18 months.  I discussed the treatment options moving forward and given his failure of adequate control with ibuprofen and meloxicam I did recommend a ultrasound-guided corticosteroid injection in the glenohumeral joint.  He tolerated this well.  I will follow up with him as needed.  If these injections are effective but his pain returns I can do these injections every 6 weeks until resolution of the adhesive capsulitis.  I will follow up with him as needed.
Information has been received from a physician concerning a 12 month old male pt with no known drug allergies who on 06/07/2001 was vaccinated with a dose of varicella vaccine. There were no concomitant medications. On 06/19/2001, the pt presented to the physician's office with about 6-8 vesicular lesions. No other symptoms were reported. Additional info has been requested.
Febrile seizure, up to 4 minutes duration 5-31-14. EMS called, patient evaluated there in office later. Only treatment was ibuprofen.
Pt was given incorrect formulation of vaccine.  Rec'd Moderna 6m-5y (Blue cap) but should have received Moderna 12+ (Red cap).
Swollen and red, area was about 3 inches circle. Hard lump where shot was given. Progressively worsened. Started taking Benadryl. 10/18: Patient saw doctor and received a Medrol dose pack and continued to take Benadryl.
Child began vomitting after the administration of the vaccines, complained of burning in her mouth, then swelling of her lips, then swelling of her face. There was no respiratory or cardiovascular compromise - 0.3ml of Epinephrine was administered and child diagnosed as having an anaphlylactic reaction and was transferred from the outpatient department to the Emergency Department.  There child developed total body redness, itching and swelling and was treated with Benadryl, corticosteroids, H2 blockers and hospitalized for observation. 12/10/07-records received for DOS 11/28-11/29/07-DC DX: anaphylactic reaction. Oral swelling, hives to face. Vomited. Admitted for observation.
Information has been received from a physician concerning one male pediatric patient who was vaccinated subcutaneously with 0.5 ml of varicella virus vaccine live (Oka/Merck), and subsequently developed shingles. Unspecified medical attention was sought. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Red, warm, hard, afebrile, ice applied. Ibuprofen given, child doesn't act any different.
Left thigh 14cm X 11.5 cm redness  given vaccine 05/11/2021, redness started 05/13/2021 7:00 am, advise to use cool compress, children's Motrin, antibiotic cream
Single dose Vial was administered as well as Kinrix.  So DTAP was doubled up by giving both Pediarix and Kinrix.
today all my joints ache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (today all my joints ache) 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 ARTHRALGIA (today all my joints ache).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt recvd vax & devel severe redness & red streaking in lt arm & was unable to move arm; devel pain @ the inject site & a 6 inch swelling; next day experienced pain in the rt arm; treated w/adrenaline, DPH, APAP & cold compresses;  CVA;
Within 3 days of receiving vaccine I have been experiencing very mild hangover like headaches.  They still persist as of this date.  Have not been to the Doctor for this problem.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
I received the first shot of Moderna COVID-19 Vaccine EUA at 1:00 p.m. on 2/3/2121. By 6:00 P.M. that evening I became nauseated, started vomiting & was weak, & developed a headache, for which I took two 500mg Tylenol.   I was in bed & slept nearly the whole time until about midnight Thursday, 2/3/2121.  During that time I got up to urinate 4 times & ate 4 soda crackers with buttermilk.
Pt describes swelling and redness, pain and itching one hour post vaccine given at the site of injection. Area on exam 26x18cm of edema, erythema and temp. Per acknowledgement letter, unable to provide the manufact. and lot number for vaccine as pt was not vaccinated at thier facility.
Patient with positive COVID test found upon admission to hospital for STEMI.  Provider d/c note:  "Patient admitted with a STEMI. Underwent emergent catheterization and intervention as above. Found to have significant disease and will ultimately need surgical consultation. On aspirin 81 mg daily and clopidogrel 75 mg daily for 30 days. Echocardiogram performed with 40-45% EF. On metoprolol 25 mg and lisinopril 2.5 mg. Incidentally found to have COVID 19. CHF education. Aggressive risk factor modification and diabetic control. Will see cardiothoracic in 3-4 weeks. No driving or operating equipment. Restrictions discussed. "
This spontanoeus report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 65 (also reported as 66) year old male patient. On 13-NOV-2012 at 16:36 the patient vaccinated subcutaneously in right arm with a dose of ZOSTAVAX (lot number H011048, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Fever details; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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 Information: GSK Receipt Date: 21-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingrix and experienced fever. Additional supportive information: The follow-up would not possible, as no contact, details were available.
It was approximately 15 minutes after vaccine was given that my daughter began screaming and crying hysterically. We were driving and I pulled over as soon as it was safe. She did not calm at all and screamed bloody murder for 20 minutes straight until she passed out. I called the doctors office and they said to call back if it started again but didn't seem concerned. I was also hysterically crying because I have NEVER ever heard a child scream and cry like that. I was terrified and on the verge of calling 911. She didn't act like herself for a week or so. She wasn't holding her head up alr cooing like she had done previously. It was the scariest thing I've ever seen with my children. She appears frontage outside to have made a full recovery but I wonder if there was any internal damage that isn't seen.
RN called today to inform RPh that patient developed a "red lump" in the same arm as the Pneumococcal vaccine administered on Friday, 6/4/2021
swelling in the shoulder; discombobulated; sweating with 70°F and a fan on / sweating profusely; most extreme case chills ever experienced in my life; continued headache; continued joint pain. Every joint, from hands to feet; redness in injection site; cold sweats; no appetite; numbness in my joints (specially in right elbow); This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in my joints (specially in right elbow)), SWELLING (swelling in the shoulder) and CONFUSIONAL STATE (discombobulated) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness in my joints (specially in right elbow)). On an unknown date, the patient experienced COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), SWELLING (swelling in the shoulder), CONFUSIONAL STATE (discombobulated), HYPERHIDROSIS (sweating with 70°F and a fan on / sweating profusely), CHILLS (most extreme case chills ever experienced in my life), HEADACHE (continued headache), ARTHRALGIA (continued joint pain. Every joint, from hands to feet) and VACCINATION SITE ERYTHEMA (redness in injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in my joints (specially in right elbow)), SWELLING (swelling in the shoulder), CONFUSIONAL STATE (discombobulated), HYPERHIDROSIS (sweating with 70°F and a fan on / sweating profusely), CHILLS (most extreme case chills ever experienced in my life), HEADACHE (continued headache), ARTHRALGIA (continued joint pain. Every joint, from hands to feet) and VACCINATION SITE ERYTHEMA (redness in injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was reported that patient also covered with a blank for chills and used light clothes for the sweating and lost 7 pounds since the second dose.
Pt c/o decreased ROM to (R) arm S/p immunization. Has to use his other arm to assist with movement. No obvious deformity, no edema or bruising to injection site. Warm/moist heat, monitor and F/u PCP PRN.
Large area of erythema and induration left arm.  Fever 103.5 and myalgia and malaise.
Throbbing bones (back, pelvis, hips, legs) with fever, chills, clamminess for 12 hours. These started within 12 hours of the injection.  Tachycardia (HR at 100)  for 6 hours along with a very tight diaphragm that made deep breathing difficult. These event started within 15 hours of the injection. Restless leg/body syndrome. This was probably secondary to the tachycardia. Once the tachycardia diminished the restlessness diminished.  Fatigue for 48 hours. This started around 6 hours after the injection.  Injection site pain and difficulty moving my arm for 48 hours. These started within 3 hours of the injection.
sick; Initial information received on 29-Sep-2021 regarding an unsolicited valid social media non-serious case received from a consumer (patient) via social media post.  This case involves an adult patient with an unknown age and gender who was sick (illness), after receiving INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.   The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (non-serious event), unknown latency following the administration of INFLUENZA VACCINE.  It was reported "The flu was renamed as Coronavirus disease (Covid-19), numbers were no different than previous years. Flu shots can make you sick not protect you from experience."  It is unknown if the patient experienced any additional symptoms/ events.   There were no lab data/ results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.   There will be no information on the batch number for this case.
Right after the vaccine was administered, my shoulder was swollen and very painful. I was amenable to move my arm. Those symptoms subsidized after 2 days. A week after the vaccine (1/19/2021), a lump appeared on my shoulder where the injection was done. The area is red, itchy and warm. Those symptoms have been observed for 2 days now.
Within 15-minutes of vaccination, the patient reported an "other" adverse reaction. There were no other details given by the vaccine administrator or clinical staff who recorded the adverse event.
Shingles on my face.  I have pictures of it and was seen by internal medicine doctor and eye doctor because of the proximity to eye.  This was my third outbreak in my lifetime.  However, my first time ever taking the Flu vaccine and having a reaction.  I was giving medication to reduce the outbreak.  (This was a requirement for a job, I will look for the paperwork with the manufacturer and specific date administered).
Extreme pain in area of shot, body aches all over, bad frontal headaches, chills, fatigue, upset stomach and foggy head. Started several hours after the vaccine. First 24 hours, I had to spend mostly on bed. On the 2nd day, the stomach and chills dissipated. On the 3rd day now, starting to feel better so far.
Felt sick but had no fever or anything after shots; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick but had no fever or anything after shots) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053F21A, 031421A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Injury (on the left side of the body).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (Felt sick but had no fever or anything after shots). At the time of the report, MALAISE (Felt sick but had no fever or anything after shots) had resolved.            No concomitant medications were reported.  The event onset date after the 1st dose was reported as 13-Feb-2021 and stop date was 15-Feb-2021, event onset date after the 2nd dose was reported as 13-Mar-2021 and stop date was 15-Mar-2021 and event onset date after the 3rd dose was reported as 18-Aug-2021 and event stop date was reported as 20-Aug-2021.   No treatment medications were reported.   This case was linked to MOD-2022-677266 (Patient Link).
1st vaccine - immediate metal taste in my mouth. This taste comes and goes but it seems there is a persistent 'metal' / yucky taste in my mouth now. 2nd vaccine - about 3-4 weeks after this dose my ears started ringing. For about 2 weeks it sounded like the ocean was in my head. It seemed to go away for awhile or almost. Now there is light ringing all of the time. When I am busy doing things I do not hear it but when I stop, it is there. I did not have tinnitus prior to these vaccine doses.
patient has about a 5 inch diameter rash at the injection site which is red, swollen, and warm to the touch