chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red soreness; Red soreness; Fever; A spontaneous report was received from a consumer concerning an unknown age, female patient, who received Moderna's COVID-19 Vaccine and experienced red soreness and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) for prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient experienced red soreness and fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events red soreness and fever was not reported.  The outcome of the events of red soreness and fever was not reported.; Reporter'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. Further information has been requested.
"Covid Arm" - Circular red rash at injection site, lump & warm, tender to touch
When I woke up I had a rash on my left arm going from where I got the shot towards my armpits and my gland under my armpit was swollen and I had to keep my arm up. I felt sick to my stomach I had tingling down to my left arm, my joints, and upper body were really painful and I had a  pain that started on the left side of my rib cage it was an awful pain. 1 week later after the shot I had rash underneath my left breast and stomach and it was very itchy and reddish.  Then I contacted the doctor and they gave me Valacyclovir and was advised to take it 3x a day. It helped a lot with the rash and the side effects.
This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323  US-009507513-1902USA009323: Original Case : 1902USA009323.
2-26-2009 Right Deltoid Red, Swollen, hard induration, hot to touch, itchy, red streaks and painful to touch.  Pain with Range of motion but has full ROM.  Denies numbness or tingling.
DTaP given on 07/23/2003- left arm warm red, hives temperature 102.
Pt c/o red warm to touch, pain with ambulation the evening after receiving vaccine. Pt was seen by provider and given Rx for Duricef and Benadryl. Also advised to use ice to area. Pt was called by the provider the next day after tx and reported she was much better.
I normally have a normal blood pressure but 24 hours after the shot it was super low.  After the first 24 hours it?s now running very high.   I?m two weeks in from first shot and all the joints in my body hurt, I have severe headaches daily, my legs are swollen and sore that I can?t hardly walk.
Became ill.  Had to urinate several times during sleep.  Dry mouth woke me up.  Finally scheduled a visit with Doctor and was diagnosed with diabetes with blood count of 385, up from 130 from annual physical 2 months earlier.
headache, chills, nausea, nasal congestion, increaced frequency for unrination and bowel movement
Patient was vaccinated beyond use date of 7/20/2022.  No symptoms reported.
Ovary pain - this occurred around 2:00 AM after the shot was taken at 1:00 PM. this continued for 36/48 hours. Doubled over in pain - my cycle, so far has not started early. I've had cysts before but not in 4 or 5 years and the pain that i experienced with them is similar to the pain that i experienced after the immunization.  Hip pain - this started around 48 hours after my vaccination and has continued for about 10 days - most sever pain lasted 4 days and i had trouble walking  and then the pain has pretty much gone away.    The rest of the reactions - fever, body aches, pain in the arm of the injection (this radiated to my wrist), fatigue,  were manageable and went away after 5 days (fever persisted the longest and only got up to 101.3 F).  there was no rash at the injection site.
Patient walked over to the waiting chairs after the vaccination. About 10 minutes later, she started feeling hot and light headed. I had her come into the patient health room to take some deep breaths in private and got her a bottle of water. she started to feel a little bit better as we checked on her a few times. We gave her 2 options for us to either call 911 but she declined so we recommended she call a friend to come pick her up. she stated that she felt alright but called someone to come pick her up about 15 minutes after the start of her symptoms. she was able to walk out on her own without problem when her friend came to the pharmacy.
Started itching, then in morning it was red and hot.  Splotchy spots, now can still feel where the injection was given.
Noticed this AM, whelps on R leg diameter 130mm L leg @ site of Hep B & Prevnar. R leg local irritation 42mm. Child is walking w/o problems. Afebrile. Noted some hardness @ injection sites. Band Aids were left on > 24hrs. Advised warm moist compresses. Tylenol/motrin. Call in 2 days if whelps still present.
Body aches/chills starting at 6pm  100.7 fever peak around 8pm. On and off body chills all night, feverish, clammy, headache, body aches, joint pain. Treatment with acetemetaphin, taking baths, sleeping. Symptoms stayed at least 24 hours after injection time.
Saturday 9/23 patient developed a fever of up to 102.7 towards the evening. On the morning of Sunday 9/24 patient felt dizziness and fainted in which her husband caught her before she hit her head. After fainting patient gained consciousness and began throwing up. After the incident patient's blood pressure was checked using an automatic blood pressure matching at home, reading 78/60. Monday 9/25 patient began feeling pain in her left leg. 9/26 there was no resolution in left leg pain, she began to notice a little swelling. 9/27 Wednesday patient noticed continued pain, worsened swelling in the left lower leg, and discoloration on her left shin. Patient went to her doctor who ordered an urgent ultrasound at 3pm. 3pm Ultrasound was completed and it was confirmed patient had a clot in her left leg leading form her thigh to her knee.
Severe swollen arm at injection site, burning, hot to the touch, lasted 1 week
Pharmacist ended up using 10 pre-drawn syringes that were drawn from a vial that was not; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Pharmacist ended up using 10 pre-drawn syringes that were drawn from a vial that was not) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Pharmacist ended up using 10 pre-drawn syringes that were drawn from a vial that was not). At the time of the report, PRODUCT STORAGE ERROR (Pharmacist ended up using 10 pre-drawn syringes that were drawn from a vial that was not) had resolved. Not Provided      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 Concomitants included. No Treatment mentioned.
Feels it may be decreasing the incidence of cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of unexpected therapeutic drug effect in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient asked does the shingrix vaccine have any affect on cold sores incident or severity. The reporter stated that the patient felt that it may be decreasing the incidence of her cold sores. The reporter consented to follow up.
11/19/2009 at 2:00 AM Complained of a severe headache and body aches.  No fever. 11/19/2009 at 7:00 AM complained severe headache still, body ache, spike in fever, nause.  Given acetaminophen and he vomited medicine up immediately.  Given a warm bath to bring fever down and second dose of medicine 8:10 AM.  9:00AM fever subsided.
2 weeks later I started getting hives under the opposite arm of injection and across the back. I have never had hives before or had an allergic reaction before in my life. it alleviated 24 hrs later with Zyrtec and reappeared again a week later under the same arm.  Also, within days I experienced throat restriction for 2-3 days and sever exhaustion.
Two weeks after 1st dose on 03/22/2021 I experienced vertigo and I continued having vertigo for about a week after that. I normally see a chiropractor and so I did see him three times that week and he tried to help me with that because we didn't know what it was from.
"A few minutes after receiving the pneumococcal vaccine, patient stated his stomach feels queasy, he feels nauseous, dizzy and feels like passing out.  Patient became diaphoretic and shaky.  Dr. was notified and responded.  Patient helped to exam table and instructed to lie down.  B/P 124/72, pulse=72.  After a few minutes, he stated he felt better.  Geven a cup of water and helped to sit up.  Patient stopped shaking and stated does not feel dizzy or nauseous.  Adverse reaction report completed and given to Dr.
Information has been received from a registered nurse concerning a 15 year old female who on 18-OCT-2007, was vaccinated with a dose of Gardasil (possible lot #'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Pt recv vax on 10/29/98; on same day pt exp red swelling of Rt arm w/ pain; 10/30 pt exp hotness at vax site to forearm; dx=allergic rx; tx=hot & cold packs, Ceclor; pt imp 11/4/98
Moderna COVID-19 Vaccine EUA Hyposphagma(Subconjunctival hemorrhage), left eye, at 11:00 am 19 Jun 21  Can I take a second shot even this symptoms occurred?
I am a very healthy and active person with no prior medical, mental or emotional history. I exercise, eat well and take care of myself. I am 5'9" and 125lbs and not on any medications.  Below are the adverse reactions from the J& J vaccine.  1. Severe Shortness of Breath  and Chest Heaviness  2. ER admission April 7 - chest x-ray, vascular ultrasound, EKG, Pulmonary CTA, COVID test in ER. Results all negative for Pulmonary Embolism or cardiac arythmia.   3. Follow up appointments - Follow up primary care, cardiologist and pulmonologist test  stress treadmill test, echocardiography, pulmonary breathing test , blood test- ALL RESULTS NEGATIVE   3. Severe symptoms lasted - 8hrs on April 7  4. time course: Vaccine - April 7 Symptoms - April 25 - June 20, 2021  5. Symptoms gradually decreased and officially subsided on June 20, 2021
Developed redness, irritation and bumps to genital area that progressed to vesicles and painful ulcerations of the labia majora, labia minora and mons pubis.
Confirmed breakthrough Case COVID-19 (Pfizer) 1 02/24/2021 Pfizer EN6202   COVID-19 (Pfizer) 2 03/17/2021 Pfizer EN6199 COVID-19 (Pfizer) 3 08/30/2021 Pfizer FC3183
This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2016 (reported as about a year ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (dose, route and site of administration, lot # and expiration date were not reported). On an unknown date, the patient lips swelled. The outcome of the event and the relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were not reported. This is one of two reports received from the same reporter, who is also a patient.
FEVER, HEADACHE, NAUSEA, SICK... PT HUSBAND WAS GOING TO TAKE HER TO THE HOSPITAL. SHE REFUSES TO TAKE MEDICATION (IE. TYLENOL OR IBUPROFEN). BUT SHE DIDN'T GO AND HUSBAND CAME IN TODAY (10/14/16) TO LET US KNOW ABOUT THE REACTION AND THAT HE WANTED US TO REPORT IT.
This spontaneous report as received from a physician refers to a 2 year old child female patient. No information about medical history concurrent conditions was reported for the patient. On 27-APR-2015 the patient was vaccinated with first dose in the series of M-M-R II (dose, strength, route unspecified). No concomitant therapy was reported. On 29-APR-2015, the patient experienced fever, diarrhea and vomiting. On 07-MAY-2015 the patient experienced rash. The outcome of fever, rash, vomiting and diarrhea was reported as not recovered/not resolved. There was no intervention done to prevent serious criteria. No product quality complaint was involved. Additional information has been requested.
Prolonged menstrual bleeding after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Prolonged menstrual bleeding after receiving Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OLIGOMENORRHOEA (Prolonged menstrual bleeding after receiving Moderna COVID-19 vaccine). At the time of the report, OLIGOMENORRHOEA (Prolonged menstrual bleeding after receiving Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were reported.  No treatment were reported.
Pain at injection site lasting 5 days.  Developed persistent rash with itching that slowly spreads down arm to elbow joint.
No adverse reaction, A 0.5ml dose was given for the booster dose instead of the correct 0.25ml dose.
vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Back pain (diagnosed 20 years ago). Concomitant products included GABAPENTIN for Back pain.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 10-Feb-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. No lab data has been provided by the reporter.    This case was linked to MOD-2021-044817 (Patient Link).
Cellulitis to left upper arm, same location as COVID vaccine arm, left arm swelling and redness
Patient DOB on first dose was documented under 01/05/1990, today patient came in for second dose and DOB is filled out as 12-21-2006
Information has been received from a registered nurse concerning an approximately 11 year old white male who on 20-MAY-1996 was vaccinated with a dose of Varivax (lot # not provided). Subsequently, the patient developed 50-200 lesions. The patient's outcome was not reported. This case was MD documented/evaluated. Additional information is not expected.
Woke up right before midnight with roaring in my ears and kept me awake for several hours, I did called VAERS no report taken. After 2nd dose, I developed tinnitus. I didn't do anything after. I figured it would go away. I went on a trip that was at higher elevation the where I live and experienced hearing loss in the left ear. When I got back home I called my primary doctor and scheduled an appt and she referred me to audiology. The audiologist gave me a hearing test and that in point time we decided not to do anything. That it could go away. It has not gone away so I am going back. I still have ringing in my ears and hearing loss, as well as a dull earache. I also have developed an ulcer in the left side of my mouth. I went to the dentist and he gave me an antibiotic and the pain would not go away and it got worse. I ended up developing bone spurs which dentist had to remove.
dose number 3; had high fevers; suffered neck and joint pain; suffered neck and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. , The patient had high fevers after each dose of the vaccine.), for COVID-19 immunization, reaction(s): "had high fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , The patient had high fevers after each dose of the vaccine.), for COVID-19 immunization, reaction(s): "had high fever". The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021, outcome "unknown", described as "dose number 3"; PYREXIA (non-serious) with onset 28Nov2021, outcome "recovered" (29Nov2021), described as "had high fevers"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 28Nov2021, outcome "recovered" (30Nov2021) and all described as "suffered neck and joint pain".  Clinical course: The patient had high fevers after each dose of the vaccine.  The third dose had the worst fevers that lasted a day. The patient also suffered neck and joint pain for two days since the third dose was injected. Reporter assessed case as non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called triage line to report fevers/chills post 2nd COVID vaccine dose (unknown vaccine type). Patient advised to report to ER due to recent chemo. Unclear if patient presented to outside ER.
11/2/23 Mother reported to clerk  that child's arm is swollen all the way around from the top of the shoulder to his elbow on day 2 after having the Dtap on Tuesday. It is 1.5 inches bigger in circumference than the other arm.  She reported to clerk that she was calling the child's pcp.  Attempt to call mother to discuss, no answer/left message.   11/2/23 1614, Mother returned phone call and reports that child's pcp consulted by telephone and was directed to the ER.  She reports child was diagnosed with cellulitis at the ER and prescribed amoxicillin.  She reports that swelling has spread up to his shoulder blade.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Vaccine administration error. Patient pulled arm away, and most of dose ended up on the surface of her skin and was not injected. Per CDC instructions, patient was given full vaccine dose in opposite arm.
Narrative: Pt received a zoster vaccine on 3/17/2016 at Primary Care Clinic. On 3/18/2016 pt presented to ER with swollen upper lip. Pt was given oral prednisone & oral diphenhydramine to continue at home for 5 days and discharge home. Condition resolved. Primary Care provider flagged pt's chart on 7/28/2022 with history of this ADR.
approximately 2.5 wks after vaccination, development of severe increasing back pain and chest pain and shortness of breath Dx acute moderately severe pericarditis with pericardial effusion, pneumonitis with bilateral small pleural effusions, hepatitis with elevated alk phos and LFT, bone marrow reaction with elevated WBC, new anemia and elevated platelets, markedly elevated d dimer and CRP with normal troponin and negative imaging for PE.
Injection site swelled about the size of an egg with redness x approximately 3 days.  She developed itching all over her body day 2 after shot that lasted 4 days. No vesicles noted.  She was treated with allegra(daytime) and Visteril at night by our employee health physicain which improved symptoms.
BlurredVision, Myalgia, Fever, NauseaVomiting, pain in injection arm, chills Narrative:
Employee was given mandatory MMR vaccine in back of left arm. Employee began to have an itchy rash on bicep area of same left arm where vaccine was given within ten minutes after vaccine administered. That was proceeded by intermittent dry cough for 10 minutes which became worse and was accompanied by some shortness of breath. Employee was then immediately taken to the hospital emergency room via wheelchair by writer and checked-in to be seen/treated. Employee was immediately placed in a Bay for triage and treatment. Employee could still talk and was alert & oriented but continued to have intermittent shortness of breath with the dry cough.