chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site it is swollen; injection site it is hot; injection site it is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site it is swollen), VACCINATION SITE WARMTH (injection site it is hot) and VACCINATION SITE ERYTHEMA (injection site it is red) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site it is swollen), VACCINATION SITE WARMTH (injection site it is hot) and VACCINATION SITE ERYTHEMA (injection site it is red). At the time of the report, VACCINATION SITE SWELLING (injection site it is swollen), VACCINATION SITE WARMTH (injection site it is hot) and VACCINATION SITE ERYTHEMA (injection site it is red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt noticed swelling, pain, and redness around vaccination site that progressively worsened following injection. Pt went to ED and received pain meds and symptoms resolved after discussion with patient/parents.
Information has been received from a licensed practical nurse concerning an approximately 4 year old patient who on 09-MAY-2003 was vaccinated with a dose of VARIVAX (Merck).  On approximately 19-MAR-2007, the patient developed few lesions.  At the time of the report, the patients' outcome was unknown.  No further information is available.
pt recv vax 1JUL96 & became pregnant (LMP 2AUG96);@ 39 week in APR97 pt devel a sinus infect & was placed on therapy w/Z-pack;4MAY97 @ 40wk pt delivered a nl baby girl;
This spontaneous report has been received from a registered nurse referring to a 19 years old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. The patient did not have drug reactions or allergies. It was reported that on an unspecified date in 2015 (reported as between July 2015 and August 2015), the patient was vaccinated with a first dose of GARDASIL 9 (strength, route, dose, anatomical location, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). The patient did not complete this schedule. On an unspecified date in 2016, the patient restarted the vaccination schedule and received two doses "(these two doses were actually the second and third)". It was also mentioned that the patient did not receive the third dose of the 2016 revaccination schedule of GARDASIL 9. On an unspecified date approximately in December 2016, the patient developed aplastic anemia. It was not known if laboratory test were performed. At the reporting time the patient's outcome and the causality assessment between therapy with GARDASIL 9 and the event was not reported. Upon internal review the event of aplastic anemia was determined to be medically significant.
After 1st dose in April about 2-1/2 weeks later these exact same symptoms described below started.  It took May and June for them to fade away. It was clear that my doctor thought I might have a brain tumor since he suggested an MRI of my head.  That was my same thoughts.  After being told that there was no way what I experienced could be vaccine side effect I took the 2nd shot. After 2-1/2 weeks My front teeth got numb, My upper lip was numb and tingly. My nose is numb and tingly and all the skin around my nose similar.  A bad headache that was different from anything I've ever had.  It's like there is a numb and tingly spot inside my brain.  My stomach has a numb and tingly feeling which also creates slight nausea and dizziness. There is a numb tingly feeling across my chest.  My fingers and toes are cold.  And even though my toes are cold my feet feel like they are burning.  It took two months for the effects to fade away for the first shot.  These are debilitating effects.  I spend a lot of time in bed moaning.  My doctor has no idea how to treat this since he is being told that side effects are only mild and go away after a couple of days. I have searched the internet for numb and tingly side effects.  I couldn't find anything at all until August.  Then suddenly I started finding others that were using the words numb and tingly the same words I had used to my doctor in May.  And then I found Dr.  He described almost precisely the exact symptoms I have.  I found lots of people describing numb and tingly nose and lips.   These side effects make me so sick that I have had to put off important surgery on my knee. If this second dose goes like the first dose then I don't expect to feel better until end of October at the earliest.
Rash on scalp.  Resulted in itchy scalp.  Treated with oral diphenhydramine and topical menthol shampoo.
Burning pain in both legs at 1:30 am, and more burning pain in both legs again at 4:00 am. I took her to urgent care after 11 am that day, and she was seen by the Childrens ER August 8, 2010 for soreness and tenderness in leg muscles and shortness of breath. Doctors could not find her reflexes that visit. She saw her doctor the following morning which was the 9th and he kept her out of school for a week and wanted rest. Since then my daughter has had numerous incidents in limbs of her body that still continue now 6 months later ranging from neck, legs, arms, buttocks and back. She has seen numerous doctors and has been diagnosed with RSD and chronic pain in her limbs. She has also had a dislocated knee patella three months ago by taking a step her knee did not respond and it popped out. No physical education since vaccine and has stopped doing martial arts.
Theagent reports, the consumer is "over due" for her third dose of GARDASIL 9.; No additional AE was reported; This spontaneous report was received from a consumer, referring to herself, a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with the first and second dose of human papillomavirus (hpv) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient was "over due" for her third dose of (hpv) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration) and her pharmacist told her that she was supposed to have it done at that time. No additional adverse events were reported.
Began w/ fever 99.3-100.1. 6/18, 6/21 red rash left armpit area with 2 pussy blisters. 6/22 4 more pussy blisters and extreme pain. Seen by MD 6/23. Given Vicodin. Blisters developed on head 6/23-6/24. Back of neck, crown of head, very painful to touch w/ blisters. More blisters (pussy) filled developed on chest 6/27/06. Seen by MD 6/27/06. Given Valtrex and Bactroban for infected shingles. L upper arm swollen, hot to touch (2" larger than R upper arm circumference) swelling and redness to L upper arm developed 6/20 06. Shingles scabbed 6/30/06. Blisters to head scabbed over 6/29/06. Shingles cont with pain off and on currently. On Neurontin for pain.
Runny nose, sore throat, sinus pressure, slight cough, headache, no temperature, fatigue. Lasted 2-3 days,  although still feel sinus pressure, runny nose occasionally - not consistently as before. Treatment - only Robitussin DM cough syrup for diabetics.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 25-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case, initially received on 07-Nov-2018 from the other health professional (nurse), concerns a 26-year-old, adult, female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion (explicitly coded incorrect product storage). It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient experienced no adverse event after the vaccination. This case (201805340) was cross-linked to the source case 201805327 due to same reporter. The reporter assessed this case as non-serious. Follow-up received from the nurse on 28-Nov-2018: Age of the patient was added in the patient tab. Route of administration and anatomical location was added in the product tab. It was reported that the patient had not experienced any adverse event after the vaccination. Narrative and case comment were amended accordingly.
Kept her from sleeping:  sneezing, nasal congestion, sinus pressure.  Throbbing headache.  No fevers. No nausea or vomiting. No treatment, just tried to stay hydrated and drank water.  No Benadryl or other OTC medications taken.
having a bad muscle and joint reaction; having a bad muscle and joint reaction; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACINE, solution for injection), via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Feb2021, the patient experienced having a bad muscle and joint reaction. The events resulted in emergency room visit and physician office visit. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon charting the given vaccine, it was found that the vial had expired 10/15/2021.
seemed confused; difficulty speaking; little achiness; tired; no sound normal; little sore at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (no sound normal), CONFUSIONAL STATE (seemed confused), SPEECH DISORDER (difficulty speaking), PAIN (little achiness) and FATIGUE (tired) in an 83-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.     Concurrent medical conditions included Hypertension. Concomitant products included Levotyrixine and ATORVASTATIN for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (little sore at the injection site). On 23-Feb-2021, the patient experienced FEELING ABNORMAL (no sound normal), PAIN (little achiness) and FATIGUE (tired). On an unknown date, the patient experienced CONFUSIONAL STATE (seemed confused) and SPEECH DISORDER (difficulty speaking). At the time of the report, FEELING ABNORMAL (no sound normal), CONFUSIONAL STATE (seemed confused), SPEECH DISORDER (difficulty speaking), PAIN (little achiness), FATIGUE (tired) and VACCINATION SITE PAIN (little sore at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.
patient presents to the emergency department and reports spinal pain, bloody stools, blood in vomit, fever, and fatigue
Information has been received from an physician concerning a female who on 02-NOV-2007 was vaccinated SQ with pneumococcal 23v polysaccharide vaccine (Lot #658447/1132U). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced soreness at the injection site 5 minutes post vaccination. The patient called the office the same day about 1.5 hours post vaccination complaining of soreness and swelling at the injection site. The patient was treated with BENADRYL and cold compresses. On 04-NOV-2007, the swelling had increased in size and the patient went to the ER. The patient was treated with antibiotics for possible cellulitis. The patient was not hospitalized. As of 07-NOV-2007, the patient had not recovered. Follow up information: It was reported that on 02-NOV-2007 at 11:00 the 54 year old female patient developed a large arm, raised area on right arm and continued to swell. The patient went to the emergency room on weekend. The patient recovered on 05-NOV-2007. Additional information has been requested.
Had difficulty breathing and heart issues in June (about 3 months after the vaccine). Had a previous history with A-FIB, etc. but seems to have been aggravated. Rapid heartbeat, put on event monitor for 2 weeks, did not show AFIB activity, showed other activities that I was not previously aware of. Had cat scan and cardio angiogram along with event monitor. Found issues with arteries on cat scan, saw Dr. in August, scheduled cardio angiogram at Hospital for 9/7/21. Scheduled to see Dr. on Oct 18th for further checkup to see how I react, given another heart medication on Oct 18th if needed. Still having difficulty breathing, not as severe as it was previously.
No additional adverse event; A HCP called to report that an expired dose of PROQUAD was administered to a patient.; This spontaneous report has been received from a health care professional referring to a 13-year-old patient of unknown gender.  The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 09-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, 1 dose, lot number U002531 has been verified to be a valid lot number with expiration date on 24-JUL-2022 (vaccination scheme, frequency, route of administration and anatomical site of injection were not provided); , and was reconstituted with sterile diluent (MRK) (strength, dose, units, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not provided), administered as prophylaxis. No additional adverse event was provided.   No additional adverse event (AE) was reported.
On 10/19/2000, the child presented with a varicella rash and a 103F fever. The patient's outcome was unknown. No additional information is expected.
Information has been received from a male who on 17-MAY-2007 was vaccinated with Zostavax (Oka/Merck).  On 17-MAY-2007 the patient experienced an aching arm and not being able to move his arm in certain ways.  As of 13-AUG-2007, the patient had not recovered.  No further information is available.
Acute inflammation of the Cervical Spine , inability to move her legs, numbness in her fingertips, hand weakness/unable to grip anything .
Case previously recorded as MA2009-3825. Initial case report received from a health care professional, via Novartis Medical Communication, on 06 NOV 2009. A 52-year-old male patient was vaccinated with 0.5 ml of Novartis H1N1 i.m. on 29 OCT 2009. On 06 NOV 2009, the patient inadvertently received another 0.5ml of the same vaccine i.m., instead of receiving S-OIV FLUVIRIN (batch no. 102041P1). No adverse event was reported. MedCom reference no.: NA09-007763.
Facial flushing, facial redness, chills,  hives, feeling of throat swelling and tongue swelling - all progressively getting worse. Post vaccination treated with IM injection of Solu-Medrol, Pepcid (pill), Zyrtec (pill).
Stomach upset; Back hurts; Neck hurts; Back of her leg hurts; Body aches/felt like every muscle in their body hurts; Typical gastro issue like nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts) and MYALGIA (Body aches/felt like every muscle in their body hurts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (She is a survival of three open heart surgery) and Heart valvular prosthesis user. Concomitant products included FLUDROCORTISONE, VITAMIN D [VITAMIN D NOS], WARFARIN SODIUM (JANTOVEN), PARACETAMOL (TYLENOL [PARACETAMOL]) and LIOTHYRONINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), MYALGIA (Body aches/felt like every muscle in their body hurts), NAUSEA (Typical gastro issue like nausea) and CHILLS (Chills). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), MYALGIA (Body aches/felt like every muscle in their body hurts), NAUSEA (Typical gastro issue like nausea) and CHILLS (Chills) had resolved.            The patient stated after the 2nd dose within 4 hours, they started having side effects; these side effects were body aches, chills, stomach upset, their back hurts, the back of their leg hurts and felt like every muscle in their body hurts, neck hurts and typical gastro issue like Reportedly, the patient waited for 6 hours before using Tylenol and heat. The patient reported that the symptoms were all gone within a day and a-half and the patient was back to their normal lifestyle.   The patient also reported that they were a survivor of three open heart surgery and had artificial heart valve.   The patient used Heat and Tylenol to alleviate the events.   This case was linked to MOD-2021-395769, MOD-2021-395919 (Patient Link).
Received shot Tuesday 09/28/04.  That PM: lack of appetite, next two days flu-like symptoms. Back of arm red and swollen. 2nd night extreme fatigue.
THE PATIENT SAID  HAS A PACE MAKER AND HAS A HISTORY OF VENTRICULAR TACHYCARDIA.  I REQUESTED HER TO HAVE THE COVID VACCINE  TAKEN IN A HEALTH  FACILITY WHERE SHE COULD BE WELL MONITORED. SHE INSISTED ON TAKING THE MODERNA  VACCINE SINCE HER   DOCTOR RECOMMENDED IT.  THE MODERNA VACCINE WAS ADMINISTERED  AND  PER PROTOCOL, SHE WAS ASKED TO WAIT FOR 15 MINUTES  BEFORE DEPARTURE.  AFTER ABOUT 30 MINUTES SHE CALLED MY ATTENTION THAT  HER HEART  RATE HAS RAPIDLY INCREASED AND REQUESTED TO CALL  911 EMERGENCY.  THE EMS WAS CALLED AND THEY ARRIVED PROMPTLY, CHECKED HER PACE MAKER AND THE VITAL SIGNS. HER HEART RATE WAS  NORMAL AND SO ALSO ALL THE  VITAL SIGNS. THE EMS CONCLUDED SHE NEED NOT GO TO EMERGENCY CLINIC  AND ASKED HER TO REST FOR  A FEW MINUTES. SHE LEFT AFTERWARDS QUITE OKAY.
I had the typical sore arm for two days after shot. However, at 1:27 this morning I woke up to my arm slightly swollen and throbbing with moderate pain as well as itching in the shot area.  I,ve researched and am not satisfied with what I?ve found.  Is this reaction common that any days after a vaccination?
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-MAY-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported). On unspecified dates, the PNEUMOVAX 23 had four temperature excursions of 32 Fahrenheit (F) Degrees (0 Celsius) for 152 hours, 31 Fahrenheit (F) Degrees (-0.555555556 Celsius) for 32 hours, 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 248 hours, and 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for 40 hours (lowest recorded temperatures). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor was product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Blister a little smaller than a dime. Has since grown a little and gotten very red including a dark red ring around it.
large 4" x 6" hot, raise, red, welt appeared around 24 hours after vaccine. it persisted despite use of cold compresses and ibuprofen taken only when the pain started. The size of the welt continued to grow until 1/28 when I took Benadryl. It took about 2 weeks for the red mark to completely subside/
Unable to abduct arm where injection was given, then swelling, hardness, redness, very warm from injection site to elbow. Still present today. Taking TYLENOL and ADVIL. Warm-cool packs to arm. Aching in back, headache.
1 month after my second Covid vaccine, I went to my plastic surgeons office and had dermal fillers done.  2 weeks later I had red blotches (welts) on my face at each spot where the fillers were injected.  I sent pictures and after talking to the nurse injector who conferred with my doctor, I was given a prescription for Medrol and Cipro.  I was seen in the office 2 days later.  Within 10 days my face cleared up. The following week after having finished my meds, my face was inflamed once again.  Called the doctors office and spoke with the nurse who  said they were not  comfortable prescribing a stronger steroid and suggested that I set up an appointment with my primary care physician who I will be seeing tomorrow (April 29).   My plastic surgeon and his nurse thought that maybe the combination of the second Moderna vaccine and the fillers were causing this adverse reaction.
Day 1 - Arm pain Day 2 - Chills, headache, fatigue, arm pain, skin warm to touch at injection site Day 3 - Arm pain, large lump (golf ball size) in left armpit area, skin warm to touch at injection site Day 4 - Arm pain, lump in left armpit area, skin warm to touch at injection site Day 5 - Arm pain, lump in left armpit area (smaller, but still present), skin warm to touch at injection site
The pt received the injection on 12/19/00. She called the clinic on 12/26/00 stating she was seen in the ER and diagnosed with cellulitis at the injection site. The pt complained of arm being numb and swollen. Pt was treated with Keflex.