chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist administered 13 year old patient with Flublok, no adverse event; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA278793 (17 years old, same reporter).  This case involved a 13 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number-QFAA2047, expiration date- 30-Jun-2021) via an unknown route in left upper arm for prophylactic vaccination on 06-Oct-2020 (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, patient had not experienced any adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt reports severe left arm muscle weakness and pain starting evening after vaccine requiring an ER visit. As of 10/28/11 pt reports that her left arm is starting "to improve" not feeling as weak. Pt concerned as she felt the injection was given too high on left arm. Patient reported pain radiated to back and chest.
Patient reported to the ED with reports of seizure like activity 5-6 times with the onset at 7:00 pm. Patient temp upon arrival is 102.5 F. Patient was treated with 70mg Tylenol and temperature resolved. No further seizure like activity.  Patient was not postictal in the ED and had no witnessed seizure activity.  Advised to Follow up with PCP.  Patient was seen by PCP on 09/09/2022. Provider advised it is presumably an adverse effect from the DTaP vaccine. Patient appears well on exam, no further seizure-like activity.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 09Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2, on 05Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; COVID-19 vaccine, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Employee states that she began to feel pain at VP site and some slight swelling. Employee stated that she let nurse know and that she was evaluated but was seemed ok. Employee then called in on 12/11/2021 stating that she awoke with bilateral arm pain, as well as possible rash to her bilateral thighs. Patient also states that her right arm was hurting her, accompanied by diffuse swelling on her entire Left arm. Patient was instructed to be evaluated further at urgent care. Patient then stated that she can go tomorrow 12/12/2021. It was expressed to patient that she needed to be seen/ evaluated and possibly treated as soon as possible. Patient agrees and confirms with verbal feedback.
experiencing muscle soreness at the injection arm; pain; take Ibuprofen or Tylenol; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 13Apr2021 13:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "experiencing muscle soreness at the injection arm"; PAIN (non-serious), outcome "unknown", described as "pain"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "take Ibuprofen or Tylenol".  Additional information: Reporter mentioned that he was experiencing muscle soreness at the injection arm and was asking if he can take Tylenol or ibuprofen for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cough  Shortness of Breath  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Sore throat  Congestion or running nose
Onset 7 hours post-injection; duration approx. 24 hours. fever, body aches, leg pain, chills/shivering, headache, neck soreness; maintained hydration and treated with warm bath, hot herbal tea, and alternating ibuprofen 200mg or Excedrin Migraine  every 6-8 hours.    12 hours post-injection: onset of muscle soreness around injection site; duration continues 72-hours post-injection. Treatment with hot-compress, arnica salve, and massage of area.
Around 10:30 p.m. that same day, before I went to bed, I could feel that I wasn?t gonna sleep well. I might?ve have started to get a low grade fever too. I didn?t have thermometer to check my temp but I could I felt warmer than usual. Woke up multiple times in the middle of the night with chills, body aches, headache and probably a good fever at this point. Went in to work at noon, late, the next day feeling awful. No appetite the whole day, still felt like a fever, body hurt to move, body hurt just sitting doing nothing, and body aches, headache, chills, fever, all persisted but weren?t as intense. I did take Tylenol that afternoon I think, could have maybe been ibuprofen. I did start to develop a sore throat in the evening and left work early because my fingers started to feel some numbness. That numbness did go away the next morning. It was then either night following, or of the vaccination I swear my heart was racing and I just could feel every beat of it. Like it seemed fast, but couldnt tell if it was. I can?t say Ive experienced anything like it.  The second night after the vaccination as well was aches, chills, mild fever, and it wasn?t as bad as the first night. The second day following the second was better. Was taking Tylenol too, and developed a little appetite finally. Only major thing that really stood out that day was my throat just felt raw. It looked raw too, and my sore throat did go away, but it was like I had strep. I don?t know how else to describe it. That is all I really have on this.
82-year-old male with a history of CHF, CAD, aortic stenosis status post TAVR presenting to the ED sent in by his nursing home due to a PICC line complication.  Patient states that he had a PICC line placed after his cholecystectomy about 2 weeks ago and was in the hospital and per chart review he grew Enterococcus and was placed on antibiotics.  Day of admission (3/2/22) the nurse attempted to push the Unasyn when it extravasated and the PICC line became occluded and dislodged. According to patient he has been increasingly SOB and developed cough which is new. Pt was on 2L NC From rehab but does not wear o2 at home.
mother reported child experienced "seizure" on 5/3/04@11:30 pm.& stated child's temp 101F tympanic.  Child pmh of seizures x3 @ 3months of age. CT-scan/eeg at that time negative. child taking 9mg phenobarbitol po, qd, according to mother.  No seizure activity since that one initial episode @ 3months. Child received 1st Pediarix @ 2months w/o any complications. Pt seen today @ 9am in the "outpatient" clinic dept for eval. diagnosed with URI.
pt recv vax 15JAN96 & pt devel a 3 plus local allergic rxn w/an area of erythema form shoulder to elbow;it was hot to touch & very uncomfortable;pt exp no wheezing or urticaria;tx w/ice & DPH & had some improvement;
loss of taste and small April 18 - 24, 2021 Racing heart rate, significant weight/pressure on chest, difficulty catching breath: - first episode April 24, 2021 - second episode included cold sweats May 4, 2021. I called 911 and was transported to Emergency Department. ED team diagnosed issue as atrial fibrillation.
36 hours after shot skin discoloration (brown/red flat patches) developed on both upper inner thighs and around both armpits.  Discoloration has not gone away and after about a week, the discolored areas on both thighs were 'puffy' with some edema.  These areas were not itchy nor was there a raised rash - just discoloration.  The area around the injection site has no discoloration.   For first few days also had some chills and tiredness, but these are gone.
1 week after injection started with extreme muscle and joint aches all over body which continue. Worse at night and the am. So far has lasted 18 days.
?COVID arm? with raised welt near the injection site that has spread out to 3 inches in diameter to the surrounding tissue. Similar to hives but long lasting. The welt has lasted several days with pain when the arm moves as well as painful to the touch. The area is hot to the touch. Headache the day after the injection.
I've never had adverse reaction to Flu shots. I've had before sneezing practically right away and then my nose started running. By evening I developed the worse cough I've ever had. Bronchial system all clogged up. Left ear seems stuffed up as it's harder to hear out of than usual. Woke up that next morning and my mouth and tongue had a coating. Had bad body chills for about a day and a half. Stuffed up and runny nose. No thermometer to take my temp. I'm taking Equalinetussin cough and chest, congestion DM cough syrup and Equaline allergy tablets antihistamine that my mother brough over as I am too sick to go anywhere.
I noticed pain in the bottom of several of my toes in both feet, in the middle of January 2023. I then noticed what looked like little red dots. I was worried of vasculitis and these little red dots were extremely painful. I shared a photo with my physician. I am willing to share these photos with VAERS.  The symptoms that I was experiencing were discoloration and pain in my toes. I had COVID-19 in August 2022. I saw my physician and he was concerned I might be having emboli. He ordered an abdominal ultrasound, and the study was normal. He basically said he never encountered this in people who have received the vaccine or who have had COVID. It resolved in about 3 weeks and has not returned. I am a physician and I do not believe this is related to the vaccine. Unless there are other people who have reported similar symptoms that I described. Sequela of theCOVID-19 infection that I had in August 2022.
Really bad diarrhea; Loss of appetite/did not eat for 2 days; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Really bad diarrhea), DECREASED APPETITE (Loss of appetite/did not eat for 2 days) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diarrhoea and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D NOS, CARVEDILOL, IRON, METFORMIN, LOSARTAN and ATORVASTATIN for an unknown indication.    On 09-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite/did not eat for 2 days) and FATIGUE (Fatigue). On 10-Apr-2021, the patient experienced DIARRHOEA (Really bad diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 11-Apr-2021, DIARRHOEA (Really bad diarrhea) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite/did not eat for 2 days) was resolving and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Migraine 3 days fever 102, dizziness, body aches, nausea, out of body experience. I couldn?t sleep
It's been 2 weeks and 2 days since my vaccine and I still have a peach pit-sized lump in my left arm (under the skin). It has gotten much smaller since the vaccination, but it is still there. It only hurts if pressed on. The pharmacist who have my husband his vaccine said I should report the lump in my are to the CDC.
Information has been received from a registered nurse concerning a 7 year old female who is cross sighted with estopia and who fainted previously with no other known allergies or medical history who on 02-APR-2007 in the AM was vaccinated SC in the right arm with 0.5 ML second dose of Varivax (Lot # 647532/0637R). At the time of vaccination, the patient was noted to have allergic rhinitis. There was no concomitant medication. On 02-APR-2007 the patient experienced seizure about 15 minutes after vaccination while she was sitting in the waiting room. The seizure lasted about 4 minutes. The patient hit her head on the wall without apparent injury. She was taken to the emergency room and the patient's blood glucose was42 when she was evaluated by a physician. It was reported that she only ate a small amount of "fruit loops" cereal that day. During the seizure, the patient had vomited and urinated. She had fainted on a previous occasion. As of 04-Apr-2007, the patient had recovered. Follow up information received from a physician indicated that on 02-APR-2007 in the AM the patient developed a generalized seizure in the waiting room after receiving the second dose of Varivax. The patient has head on the wall, vomiting once, and voided. The blood pressure was 60/48. The patient was awake by the time EMS transported her to the hospital. A CT of the head was normal. The patient recovered on 02-APR-2007. The reporter considered the events to be other important medical events. No additional information is expected.
Patient reported that on Saturday (day after her vaccination) her arm was sore and couldn't move it as much. Sunday she felt achy all over and she took 2 doses of TYLENOL. Monday her arm started to feel warm and still felt sore and then welts started to appear and the area was red and a little swollen. Tuesday she said some of the welts reduced in size and other started to appear and still had some arm soreness and has stayed pretty much the same in terms of soreness. Patient tried using TYLENOL but didn't help as much, patient cannot take NSAIDS due to her previous ulcers. I recommended to the patient that she seek medical attention if it's still hurting her. She hadn't seen her PCP in over a year.
shingles rash near injection site; shingles rash near injection site/this rash is consistent with shingles; shingles rash near injection site/this rash is consistent with shingles/eruptions are irregular in size and shape; this rash itches; pain associated with the rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 29Apr2022 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Drug allergy", notes: Known allergies: ampicillin; E mycin, reaction(s): "Drug allergy", notes: Known allergies: e mycin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: Jan2021, when the patient was 68 years old, for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical location: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: Mar2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset May2022, outcome "not recovered", described as "pain associated with the rash"; VACCINATION SITE RASH (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site"; HERPES ZOSTER (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site/this rash is consistent with shingles"; RASH VESICULAR (non-serious) with onset May2022, outcome "not recovered", described as "shingles rash near injection site/this rash is consistent with shingles/eruptions are irregular in size and shape"; RASH PRURITIC (non-serious) with onset May2022, outcome "not recovered", described as "this rash itches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site rash, herpes zoster, rash vesicular, rash pruritic, rash.  Additional information: It was reported that two weeks after first booster, third vaccine, patient developed a shingles rash near injection site. The patient inoculated with a shingles vaccine, but this rash is consistent with shingles in that it itches, eruptions are irregular in size and shape, and there is pain associated with the rash.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
faints on the field; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a 18 years old and unknown gender patient who faints on the field while receiving vaccine INFLUENZA VACCINE.  The patient's past , medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength, route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination. Information on lot number was requested.  On an unknown date the patient faints on the field (syncope) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  There were no lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (faints on the field).  At time of reporting, the outcome was Unknown for the event faints on the field.; Sender's Comments: Sanofi Company Comment dated 03-Feb-2022. This case involves a 18 years old and unknown gender patient who experienced faints on the field while receiving vaccine INFLUENZA VACCINE.. Based upon the reported information, the role of a vaccine cannot be assessed  Further information regarding time to onset, cause of faint,  previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Right arm swelling at site of varicella/immunization. Complained "painful and hard" raised area 6cm. Benadryl 25mg q 8 hrs prn, cold compress to site.
High fever >102F, treated with acetaminophen first 2 nights. Had irritability for 2-3 days, loss of appetite for 2-3 days, abdominal pain for 2 days, inconsolable crying for 2 nights and diarrhea for 3 days. At 8 months of age, had local swelling and irritability with 2nd DTAP and IPV vaccinations.
Almost one year after receiving the first booster of Moderna, I tested positive for Covid-19. I am a school teacher and I consistently wear my mask, but the mandate at school was dropped. I continued wearing the mask and I stopped wearing it two weeks prior to testing positive for Covid. None of my students were wearing masks any longer either. I feel that the mask was really helping with keeping me Covid free. I was Covid free for over two years and once the mask came off, I tested positive. I have noticed that I am still experiencing symptoms of being short of breath and just exhausted.
On 13Sep I started having troubles breathing- getting winded doing simple tasks. I am still having this symptom today 17Sep. Also on 13Sep I started having itchiness on and around the injection sight. This symptom is still ongoing.  On 17Sep I woke up with a rash around the injection sight. The rash started at quarter size and is now about the size of a softball.  Treatment has been a cold compress for five minutes to try and alleviate the itch and rash from spreading. Results of the treatment has lessened the irritation of the rash.
pt recv vax 17JAN96 that had been reconstituted for 48hr;
This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site swelling (developed swelling at injection site about a size of a golf ball 4 hours later) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had vaccination site swelling (developed swelling at injection site about a size of a golf ball 4 hours later). At the time of the report, vaccination site swelling (developed swelling at injection site about a size of a golf ball 4 hours later) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
She had a shingles vaccine last Thursday at facility and went to the ER yesterday evening as her upper arm around the injection site was hot and hard.  She was diagnosed with cellulitis and started on clindamycin.
Redness, warmth, and edema to site. Fever and tachycardia. Treating w/ tylenol for fever.
DIAPHORETIC, LIGHTHEADED, FLUSHED AFTER RECEIVING FIRST SHOT
Apnea episode the night of the vaccine (had not had an episode since his adenoids were removed). The episode was approximately 30 seconds (we have a monitor that begins sounding after 20 seconds of no breathing). He fully woke and began breathing approximately 10 seconds after the alarm sounded. Additionally, he is extremely irritable the day following the shot (date of this report). He has not had irritability with any prior vaccines.
Case number PHEH2012US020881 is an initial spontaneous report received from a medical assistant on 16 Oct 2012. This case refers to multiple patients. These patients were vaccinated with MENVEO (batch number: A11076) intramuscularly on unspecified dates. The reporter stated since 22 Jun 2012, the refrigerator that stores un-reconstituted MENVEO vials has reached temperature down to 0 degree C on 15 different occasions. Duration of excursions was not known. It was also not known if the vaccine froze or not. No adverse event was reported following this drug administration error.