chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin cancer; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (skin cancer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2021, the patient experienced MALAISE (did not feel well). In August 2022, the patient experienced SKIN CANCER (skin cancer) (seriousness criterion medically significant). At the time of the report, SKIN CANCER (skin cancer) and MALAISE (did not feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, Biopsy: some type of skin cancer.         Concomitant product use was not provided by the reporter.   In Aug 2022, patient saw the physician and removed a small bump on patient's neck. Sent it off for a biopsy and said that it was some type of skin cancer which the patient could not remember, and patient did not feel well after the second Moderna vaccine and decided not to have any more. This was prior to starting Humira.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Treatment medication was not provided.  Company Comment: This spontaneous case reported by a consumer concerns a 69-year-old male patient, with use of co-suspect non-company product Adalimumab solution of injection for plaque psoriasis, who experienced unexpected, serious (medically significant) event skin cancer, approximately 1 year and 5 months after vaccination with a second dose of mRNA-1273.  The patient reports having a small bump on his neck.  It was removed and sent for biopsy which revealed some type of skin cancer which the patient could not remember.  Further clinical course and treatment details not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer concerns a 69-year-old male patient, with use of co-suspect non-company product Adalimumab solution of injection for plaque psoriasis, who experienced unexpected, serious (medically significant) event skin cancer, approximately 1 year and 5 months after vaccination with a second dose of mRNA-1273.  The patient reports having a small bump on his neck.  It was removed and sent for biopsy which revealed some type of skin cancer which the patient could not remember.  Further clinical course and treatment details not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
pain from the injection site; redness at the injection site; swelling also at the injection site; Fatigue; GI symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 22nd September 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fatigue and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix at Left deltoid almost immediately had pain from the injection site, along with redness at the injection site. The patient also had swelling also at the injection site, along with fatigue and GI symptoms. The patient stated that she was calling to report this because the instructions said to report any adverse events . The reporter did not consent to follow up.
COVID+ 10/22/22 - Vaccination status - Moderna x2 + 1 pfizer booster BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: PA Admission Date: 10/22/2022 Discharge Date: Oct 24, 2022 Discharge Disposition:  home or self care    Active Issues Requiring Follow-up:  Acute respiratory insufficiency with hypoxia COVID-19 - Home oxygen, 2L with activity, can try to be off oxygen at rest - Dexamethasone, sent with 7 days to complete 10 day course as she is going home with oxygen - Enrolled in transition to home monitoring program   Incidental imaging findings: Nodular opacities 7-8mm - Incidental finding on CT abd/pelvis - Most likely 2/2 infectious process - Consider repeat imaging to ensure resolution   Patchy heterogenicity in region of uncinate process of pancreas - MRCP recommended to exclude underlying mass  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Community acquired bacterial pneumonia [J15.9] Paroxysmal atrial flutter (HCC) [I48.92] Other pulmonary embolism without acute cor pulmonale, unspecified chronicity (HCC) [I26.99] Community acquired pneumonia of left lower lobe of lung [J18.9] Stage 3 chronic kidney disease, unspecified whether stage 3a or 3b CKD (HCC) [N18.30]   HOSPITAL COURSE: Patient is a 74 y.o. female with PMH significant for COPD, h/o PE, CAD with h/o MI s/p stenting, atrial fibrillation, h/o v fib, h/o NSVT, CHF and hypothyroidism who presented to the ED on 10/22 with chest pain and SOB. Symptoms started 3 days beforehand, but continued to progress and she developed sharp right sided chest pain.    In the ED, patient was hypoxic at 88% requiring 2L oxygen. CXR without any acute changes. CT abd/pelvis showed no acute abdominal findings but did demonstrate patchy left basilar airspace opacities suspicious for pneumonia with incidental findings as noted above. Patient was started on Rocpehin/zithromax and admitted to medicine for CAP. Shortly after COVID testing returned positive. Pneumonia was attributed to viral etiology and abx were stopped. She was started on dexamethasone and remdesivir. She continued requiring 2L nasal cannula, but later weaned to room air. She was concerned about twitching in her chest and CXR to evaluate ppm/ICD lead placement, which was reviewed and stable, and twitching resolved on its own. Given her stability and mild improvement in oxygenation, we discussed COVID at home program. She was agreeable to this. Rehab consulted and recommended 2L with activity, though at times, she may also need oxygen while at rest. Given home oxygen, and COVID at home transition program, she was discharged in stable condition on 10/24/2022. CONSULTS / RECOMMENDATION: Rehab - home oxygen Transition to home program
This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Tinnitus. Woke up with loud ringing in both ears, which has yet to subside. This has never happened to me in 61 years, so I'm very sure this is related to the shot. Prior to that, I had run a fever, and had my whole upper arm swollen and hot , which have both just started to subside.
Attendee received first dose Pfizer vaccine at 11:51 in the left arm.  Lot# FA6780. Attendee was assisted to the vaccine area by the vaccinator to observation area, as the attendee was so nervous.   At 11:52 voiced complained of dizziness, slight chest tightness and was pale.  Attendee's skin was warm and diaphoretic.  Attendee's respirations were tachypneic. Cot brought to the attendee to lie down, legs elevated, icepack applied to face and neck. Flushing on her chest noted. Chest tightness reported. Declined Benadryl and Zyrtec.
SWOLLEN, HOT, VERY PAINFUL AT INJECTION SITE. COULDN'T LIFT ARM.
Tuesday evening fever swelling entire arm bodyaches. She put ice on arm took ADVIL that evening. She started to feel better Wednesday. Swelling went down some on Thursday. Swelling reduced some everyday. Still sore still swollen red and warm to touch.
Employee alleges bilateral blepharedema, along with swelling of lips. C/O slight chest tightness but no frank shortness of air. Employee did not seek medical treatment as of this date. Employee also alleges similar symptoms last year, following the flu shot, but "did not put it together until it happened again this year".
On 2/4 through 2/7-arm pain 2/4-2/17 frequent bowel movement and occasional diarrhea, fatigue, poor sleep 2/16 COVID Arm - tender hot at injection site, 3x4 inch splotch, red outline slightly raised, arm and neck pain
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 03-NOV-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # K021152 and expiry date 02-NOV-2016) (dosing regimen unknown). No adverse effects reported. No temperature excursions were reported. No product quality complaint was filed. Additional information has been requested.
my arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Shingles vaccine was discontinued. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient had Shingle shot and stated never want the shot ever again his/her arm was sore for 5 days just terrible all of it. Additional supportive information: The follow-up could not be possible as no contact details were available.
pt fell asleep about 20min p/vax;awoke 2 1/2hr later screaming very high pitched;pt pale;mom called MD while one phone pt stopped crying & went limp;mom could not give pt a bottle or awaken pt;dx shock collapse;t101 R;
immed p/vax wheal formed just above the site 2cm across w/erythema 3-4cm around wheal given DPH by mouth & observed for 30min;mom reports no known allergy to eggs-pt eats them
Throat pain first, so I gargled and went to bed. Awoke around 11:30 PM with nausea/chills, difficulty breathing/swallowing/talking. Call nurseline. Was advised to go to ER. Went at 6:15 AM. Given a steroid shot and breathing therapy. Symptoms continued. Visited ENT on 5/19/14. Given steroid prescription. Today, 5/20/14, back at work and sore throat persists.
Started with fever, chills, nausea. Then threw up and had diarrhea through out the remainder of early morning with severe bloody diarrhea. Abdominal pain was intense like child labor. Went to hospital in morning abount 9 am.
After having the covid vaccine she felt more tired and no strength; After having the covid vaccine she felt more tired and no strength; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 26-year old female patient that she received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from 2018 (Batch/Lot number was not reported; Expiration Date: 30Jun2023) and ongoing, at 5 mg, twice a day for an unspecified indication. The patient medical history was not reported. Concomitant medications included baclofen (BACLOFEN); empagliflozin, metformin hydrochloride (SYNJARDY); levothyroxine sodium (LEVOTHYROXINE SODIUM); paracetamol, tramadol hydrochloride (TRAMADOL HCL AND ACETAMINOPHEN); lisinopril (LISINOPRIL); gabapentin (GABAPENTIN); fluoxetine (FLUOXETINE); fish oil (FISH OIL); rosuvastatin calcium (ROSUVASTATIN CALCIUM); dulaglutide (TRULICITY); calcium, colecalciferol (CALCIUM +D3) taken for an unspecified indication, start and stop date were not reported. Patient states that after having the covid vaccine she felt more tired and no strength 4 days after receiving the covid vaccine and for a couple days after that. Md unaware. (withheld) any missed doses. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Swollen lymph glands under injection arm only for first 2 days after shot. Vertigo with nausea began on third and fourth days. Vertigo is still felt, but without nausea, 10 days after injection (today), but is not as severe as the first 2 days.
pt had fever/chills x 2 days headache x 3 days. pt had rash on back of neck inner arms and upper thighs bilaterally
This was the Moderna Booster shot that was administered at the local Vaccine Facility.   Had a sore arm for few days and lymph nodes swelling after day 2 for few days. But after day 9 I started getting Hives  and itching all over the body which because uncontrollably and had to go the Urgent care doctor at midnight. The doctor there Prescribed medicine as below for 5 days  PREDNISONE -  1 per day for 5 days HYDROXYZINE - 4 times a day for 5 Days   after day 4 it was still not helping and was Low and sleepy all the time could not work or do any basic Activity.  Went to out regular Doctor because it worsened there was heart burn and throat pain which was making it difficult to swallow.   She looked at it and suggested to take Oat bath and Use Calamine Spray to reduce itching and administered an Injection ( dont know which it was can reach out to my doctor to get details)  She prescribed below medicine for 20 Days Zyrtec - 1 time every morning. HYDROXYZINE - 1 times a day at noon Benadryl 25mg - 1 time at night OMEPRAZOLEDR 20mg - 1 before breakfast
This spontaneous report was received from a other health care worker and refers to an 40 year old female patient with allergies to codeine and theophylline. The office managers informed that on 19-MAR-2015, the patient was vaccinated with the first dose of MMR II (lot# K020188, expiration date 22-OCT-2016) (strength and dosage were not reported) Subcutaneous, left deltoid reported as "Lt Del", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. None illness at the time of vaccination was reported. No concomitant medication was reported. No adverse effects were reported. None relevant diagnostic tests and laboratory data were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
Information has been received from a 48 years old female consumer with a history of shingles, (patient stated that she had shingles twice in the past 2 years) and a drug reactions/allergies which included: a drug reaction to food preservatives and seasonal allergies who on 16-NOV-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included SYNTHROID. On 17-NOV-2007 ("at around 7:00pm") the patient experienced a "severe allergic reaction" after receiving the vaccine. The patient reported that her lips and face were swollen. The patient also noted that she was brought to the emergency room on Saturday and Sunday nights. She was given IV and steroids in the emergency room. No further information was provided. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested. Follow-up received 04/16/2008 from a physician concerning a 48 year old female with a history of "hypersensitivity to MOBIC (which causes angioedema"), who on 16-NOV-2007 was vaccinated subcutaneously into the left arm with a first dose of zoster vaccine live (Oka/Merck) ("Lot # 00883U"). The patient had a rash at the time of vaccination. On 19-NOV-2007 the patient presented to the emergency room with a "significant rash" and was given BENADRYL and prednisone. The physician reported adding ZYRTEC. The patient's symptoms of itchy rash improved and steroids were stopped by 30 NOV 2007. The patient was considered recovered as of 10 NOV 2007. Additional information is not expected.
Pt given Engerix-B booster on 24OCT90, following nonresponse to 3 doses of Recombivax-HB & still has no antibodies.
A large raised welt/bump appeared underneath where the vaccine had been administered. I iced the inflamed area, and today it has been spreading. The are is now 3 inches long, and 1 inch tall. Area is no longer raised, but is still warm to the touch, sore and red.
Morning after injection, child woke up with nausea and stomache ache.  Arm very sore for 4 days, including his armpit. Complained that it hurt if he moved his arm or it was touched. Developed redness and swelling with a hard lump (roughly 3" in length and 1" in height) at the injection site.  Also bruised and developed 2 little bumps in the swollen area at the injection site.  These bumps lasted at least 5 days.
She left the booth to switch with her brother who was also getting a vaccination. When I was done with his I heard the mother saying  that she had passed out.  It was about 4 minutes or so after she had received her vaccination.
About 2 months after my second shot, I started having horrible monthly menstrual cycles.  I have severe cramping, blot clots, trouble sleeping.
rash across mid section and blotchy on face.   She called nurse line, they advised her to take benadryl and she reports things are resolving.
Tinnitus/loud ringing in both ears. Buzzing sound during the day and night 24/7
Staff member at facility was watched for 15 minutes.  Around 2:15pm she vomited, then chest tightness and severe pain in left arm began.  She was given Benadryl at 2:30pm and EMS arrived at 2:45pm.
Day 1: Was awakened by a nightmare.  Then, Throbbing intense headache, severe pain in entire left arm which spread to shoulder, scapula and back ribs.  Fever (no thermometer).  Intense fatigue.  Could not get out of bed for first 6 hours because of weakness.  Loss of appetite for first 12 hours.  Ate white rice and ginger ale only. Day 2: Fatigue continued, but to a lesser degree.  Ate items from the BRAT diet. only Day 3:  Continued to improve, but still had fatigue.  Day 4:  Felt like myself again.
My arm had localized swelling at the injection sight, big as 10 CM around and raised up 3 CM. It looked like a positive TB test. It was hot, extremely painful. There was an indentation in the middle where the needle went in and it scarred there. Doctor had me take Tylenol for the pain and alternate cold packs on it.  Looks like a small pox vaccine.
About a week following my 2nd shot I noticed extreme fatigue. Almost like what I had the day of the vaccine. It is August and this is still getting worse. I have had pressure in my left arm on and off since the first injection. About March I started noticing a change in my memory. I started having a lot of cognitive/neurological issues. Over this time I have had days where my speech was slurred and on a regular basic I run into walls and doorways due to a change in my balance. This has become very distressing.
developed urticarial rash on Tuesday (8/3) after receiving first covid vaccine on Sunday (8/1)
15 mins after receiving the vaccine, I began feeling nauseous. One hour after receiving the vaccine, I began throwing up. I could not keep anything down until 2 PM the next day. I was also extremely tired and slept most of the next day. I was 10 weeks pregnant at the time of receiving the vaccine. Had a terrible headache. I took Tylenol for the headache.
Pt has large area about half dollar size of bruising with tenderness and the site is itching.  She states this began on Monday morning
Patient received Prevnar vaccine at pharmacy on August 23, 2021 and woke up the next day not able to move neck and arm.  He claimed he had to pick up his arm with the other hand.  He said it attacked his muscles and nerves. He said he wasn't getting better so he went to an urgent care on August 29, 2021.  He was given an anti-inflammatory and muscle relaxant.  He said the doctor he saw told us to report it.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) 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 EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.
Received MMR and VZV on 9/9/08. Client called 10/22/08 = she is pregnant. Last period 9/15/08 - she was alert by nurse to not pregnant x 1 months - call @ PC.