chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Just didn't feel good; Arm was swollen to the elbow; Arm was red; Redness/swelling/lumpiness began to wrap around her arm to her armpit; Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site; Light itching all over her body; Achy Muscle and joints; Nausea; Achy Muscle and joints; Arm hurt; Migraine; Vertigo; Dizziness; Flu like; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness) and INFLUENZA LIKE ILLNESS (Flu like) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), ARTHRALGIA (Achy Muscle and joints), NAUSEA (Nausea) and MYALGIA (Achy Muscle and joints). On 19-Feb-2021, the patient experienced VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site) and PRURITUS (Light itching all over her body). On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen to the elbow), ERYTHEMA (Arm was red) and SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit). In May 2021, the patient experienced MALAISE (Just didn't feel good). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 24-Feb-2021, PAIN IN EXTREMITY (Arm hurt), MIGRAINE (Migraine), VERTIGO (Vertigo), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu like), ARTHRALGIA (Achy Muscle and joints), NAUSEA (Nausea) and MYALGIA (Achy Muscle and joints) had resolved. At the time of the report, VACCINATION SITE MASS (Lumps the size of quarters in a 4 x4 inch patch, 3 inches below injection site), PRURITUS (Light itching all over her body), MALAISE (Just didn't feel good), PERIPHERAL SWELLING (Arm was swollen to the elbow), ERYTHEMA (Arm was red) and SKIN MASS (Redness/swelling/lumpiness began to wrap around her arm to her armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.     This case was linked to MOD-2021-291127, MOD-2021-291781.
Breast pain same side as injection day of; Feelings of being hyper and lots of energy; Period unexpectedly started early 2 days later, heavy; Period unexpectedly started early 2 days later, heavy; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 14:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient's medical history reported COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took diphenhydramine hydrochloride (BENADRYL), sulfamethoxazole; trimethoprim (BACTRIM) and levofloxacin (LEVAQUIN); and experienced drug allergy. On 21Apr2021 at 18:00, the patient experienced breast pain same side as injection day of, feelings of being hyper and lots of energy and period unexpectedly started early 2 days, later heavy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events breast pain same side as injection day of, feelings of being hyper and lots of energy and period unexpectedly started early 2 days later, heavy was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning an approximately 14 year old patient who on an unspecified date was vaccinated with the first dose of GARDASIL. It was reported that after received the first dose of GARDASIL, in two instance, the patient experienced more of a general rash after getting vaccine. It was reported that the patient did not continue on with the series. So, the patient only received the first dose.  The patient's outcome was not reported. This is one of the two patients concerning the same source. Additional information has been requested.
About two days after receiving the vaccine, I woke with similar symptoms to when I had Covid (headache, body aches, nasal congestion, sore throat, severe fatigue). It was significant enough to miss two days of work. At the time of form completion it?s been 8 days and I?m still sick.
Numbness of the left arm below the elbow including the hand (same arm as injection) that started a couple minutes after the injection and lasted for about 20 to 30 minutes. Full feeling returned and no other numbness experienced since.
Two styes in my eyes, treated twice by eye doctor. Bubbles in my urine,blood in urine, more back pain and more stomach pain
Day 3 after my first dose my right arm, chest, right breast, and neck along with spots on my cheeks and my stomach,  all broke out in a red rash that was itchy and had a burning sensation to it.  I used hydrocortisone cream on it and it helped the itching but 5 days after the rash had calmed down, I started getting flare ups of the rash again. My skin would get blotchy and be itchy.
Rash/hives, itchy, hot Moved to various places over my body with each night getting worse for 3 nights. The first night I thought bug bites or maybe touched a plant and had a reaction. Went to doctor on Thursday 2/11 thought may I had may developed shingles but they said it wasn?t shingles. My husband took pictures because it would come and go.  They prescribed 25 mg of hydroxyzine and I took one pill that evening and things have been fine since then. I haven?t changed anything else.
Frequent pain (nerve related) in the right leg, especially when not moving (lying in bed, etc).
Shingrix vaccine was improperly administered via Subcutaneous route instead of IM.  Researched on CDC website that dose is still valid when given subcutaneously.
Red welt on right arm injection site that itched.  No treatment was given, event subsided
A bump on my right arm formed.  At first I thought it might be a pimple.  I don?t recall exactly when I first noticed but by 10/17 I thought perhaps it was a bug bite that I was having a reaction to, however topically applied hydrocortisone did not eliminate the issue.  Over a week the bump grew marginally.  A week later the bump began to widen with a stiff edge and squishy center that became more tender as more time passed and I suspected an infection.  After a week of topical antibiotic ointment and heat compress, no improvement.  I felt hot but did not have a fever and decided to have a physician look at it on 10/30 to decide if it was an abscess that needed to be relieved.  Physician confirmed condition..
I opted for the J&J variant and received it on Monday at 1:00 PM, mere hours before they pulled distribution of it on the national level.  I started feeling flu like fatigue, body aches, and a headache 8 hours post injection. I ran a 101+ fever Monday night and got less than 4 hours sleep due to fever and fairly intense muscle aches. On Tuesday morning the headache, fever and muscle aches persisted till the late evening accompanied by general fatigue. By 9:00 on Tuesday night I was feeling significant improvement and slept well Tuesday night with minor night sweats on and off. Wednesday morning I felt 80% back to normal. No fever, minor headache only evident when standing up quickly or sudden head movement, and continued muscles aches body wide specifically in the neck and chest as well as injection site muscle soreness. These symptoms continue to persist into Thursday at the same or perhaps slightly elevated levels. Friday 4/15 symptoms persist with generalized soreness, fatigue, headache,  injection site soreness. Not his typical self.
Tremors, chills and increased Blood pressure (190/60). No fever.  Headache and nausea.  Later in evening and overnight blood pressure low: 44/23 and 77/54 before recovering in morning to 125/86. Recommended that patient seek medical attention immediately.  Do not know outcome.
Apnea, bradycardia and seizures, approx. 24 hours, post vax. Intubated and air lifted to hospital PICU. Extubated on 2/21/01. Discharged on Phenobarbital and caffeine.
I began to get chest tightness about 25 minutes after the shot. After I got home about 40 minutes after the shot I used my albuterol rescue inhaler and my chest tightness went away.
10:02 - Vaccine given by doctor, EMT. Patient was monitored for 30 minutes after vaccine was given. After 30 minutes she stated she felt fine and left with her mother.  10:42 - Patient returned to the vaccine clinic anxious and stating that she didn't feel well and her throat was feeling tight and getting worse. She was assessed and epinephrine was administered via epi pen by  RN. Within 15-30 seconds she stated she was experiencing relief.   11:00 - Diphenhydramine 25mg was given via injection per doctor. 11:15 - Patient was transported to ambulatory, via her mother, for observation. Doctor gave a report via telephone to the facility prior to her arrival.
Patient waited to get the second dose; Left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurt) and PRODUCT ADMINISTRATION INTERRUPTED (Patient waited to get the second dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm hurt) and PRODUCT ADMINISTRATION INTERRUPTED (Patient waited to get the second dose). At the time of the report, PAIN IN EXTREMITY (Left arm hurt) and PRODUCT ADMINISTRATION INTERRUPTED (Patient waited to get the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  The patient reported that the reason behind a large gap between the first dose and the second dose was due to she had no facility close to her that supplied the Moderna vaccine.  No treatment information was provided.   This case was linked to MOD-2021-291331 (Patient Link).
bradycardia; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single, and second dose via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient reported that he had both doses of the Pfizer BioNTech Covid-19 vaccine in Mar2021, and has been experiencing bradycardia in the 30s. He stated that nothing has changed in his dietary or fitness habits, but there has been a marked change in bradycardia since the shots according to his fitness watch. Has been to his HCP and had an EKG done. Also reported that he couldn't get in to see a cardiologist until Nov2021. At times the patient's resting heart rate has dropped into the 30s. This event correlates shortly after the vaccine. The caller did not know if this is from the vaccine or not. The outcome of event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Emergency Department Note (Verified) Visit Date:  04/13/2021  CHIEF COMPLAINT: Shortness of breath.  HISTORY OF PRESENT ILLNESS: The patient is a 65-year-old male with a history of hypertension and congestive heart failure, presents with shortness of breath that started on Friday and worsened significantly this morning.  He does have some chest discomfort with this.  No fevers, chills, or other complaints.  Discharge Diagnoses   1. Hypertensive emergency, 04/13/2021  2. Chest discomfort, 04/14/2021  3. Heart failure, systolic, 04/13/2021  Assessment and Plan 65M w/ HTN and HFrEF p/w hypoxic respiratory failure i/s/o a hypertensive emergency. BP and respiratory status much improved, admitted to CCU for acute BP management and medication titration.   #HTN Emergency Likely precipitated by lack of medication non-adherence since 04/11, when he ran out of his medications. SBP approx 220 at time of presentation, good response to enalapril and nitro gtt. Decreased work of breathing with Bi-pap. MAP 130-140 on presentation, will attempt to lower by 20-25% in first 2-6hrs w/ MAP goal of approx 100, while aiming towards normotensive in next 24-48 hrs while transitioning from IV to PO meds. -TTE ordered -cont incremental BP mgmt:  -goal MAP < 110    -prn hydralazine  -gradual goal towards normotensive over next 24-48hrs thereafter -cardiac monitor -will ensure that patient has anti-hypertensives prior to DC -q4hr neuro checks  #Acute Hypoxic and Hypercapnic respiratory failure  Decreased work of breathing with Bi-pap. Likely related to HTN emergency as above in addition to moderate-severe volume overload as seen on CXR. VBG in am of 4/13 showed pH 7.17, pCO2 64, pO2 58, bicarb 24. -cont Bi-pap, will wean as tolerable  -repeat VBG this am for resp acidosis  #HFrEF w/ acute exacerbation Last echo 04/14/2017, LVEF 38%, cxr on admission shows moderate-severe volume overload. -TTE ordered on 4/13 -may consider additional diuresis, given furosemide in ED on presentation, mindful of BP -goal net negative 1-2L/24hrs as pressures permit -daily standing weights -fluid and sodium restriction when off Bi-Pap  #NSTEMI Likely type II given HTN emergency, did have chest pain on presentation which was relieved with BP control. -trend trops until flat, next at 08:00  #type II DM Hgb A1c 7.5% on 4/13, mild hyperglycemia on presentation -SSI  #polycythemia Could be indicative of undiagnosed OSA vs manifestation of heart failure. Additionally, hemoconcentration from CHF i/s/o HTN emergency is another possibility. -TTE as above -ctm w/ am labs  #lymphocytosis Afebrile, no urinary symptoms. Hypoxic on presentation, likely related to edema i/s/o HTN emergency as above. No suspicion for infectious etiology at this time, no white count. -ctm w/ am labs  #HLD -cont statin  #QTC prolongation 561 on 4/13/2021 -avoid QTc prolonging medications
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours.  Since then, I still have numbness on the right side top of head and intermittent EXTREME  tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The  right side of my head has stayed numb.   Will this go away? Should I get the 2nd dose or not?
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030871 and expiry date 10-JUN-2018) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
8 days after injection, my shoulder was sore, felt tight and was difficult moving it freely. On the 9th day, I realized the injection site was red and  6? in diameter. The area was hard and warm/hot to the touch. I went to urgent care and  was seen by a doctor. I was given cephalexin in case I developed an infection.
17 out of 50 doses are not sealed. 18 out of 50 have already been administered; No additional AEs; Caller states foil is not sealed on ODT's from two boxes; This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age or gender.  The patients' pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies were not provided.  On unknown dates, the patients were vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) whose foil was not sealed, at a dose of 2 milliliter via oral route (lot number 1707486 has been verified to be valid, expiration date reported and validated as 20-MAR-2022; vaccination scheme was not reported) as prophylaxis (poor quality product administered).  On 29-JUN-2021, the reporter identified that the foil was not sealed on ODT's from two boxes of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) with same lot number, and 17 out of 50 doses were not sealed (product container seal issue). It was also reported that 18 out of 50 doses had already been administered and 15 left out did not appear to be affected. No additional adverse event were reported.  This is a non-valid case due to the lack of patients' identifiers.  Follow up was received from medical assistant on 06-JUL-2021. Medical assistant found another doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) which were not sealed. This time the reported found 12 out of 25 pieces of vaccine ware not sealed. On an unknown dates, 3 out 25 doses were administered. Ten doses are still intact and will be returned, as all affected doses did not fit in one mailer, second mailer would be send.. All vaccines found had the same lot number 1707486. The reporter was inquiring if the not sealed vaccines ware able to be used.
Pt  started getting nauseous and did vomit a little bit after the vaccine. Her mother stated that this happens to her with every vaccine she receives.
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
1/21/2021 - 9pm, slight aches in neck muscles 1/22/2021- 3am, fever 102.8 F (forehead) and 102.1 F (ear), chills, body aches, joints achy, headache, slight sore throat, couldn't sleep.  Took 2 butalbital and drank Pedialyte; forehead temp was 100.1 F by 5 am, and 99.7 F by 6 am 7:30 am (1/22/2021) fever returned and was 102.2 F (forehead) and 101.4 in ear. All other symptoms remain the same. Took 2 butalbital and drank more Pedialyte Called doctor and left voicemail with nurse to put these notes in my chart It should be noted that I had Covid-19 from onset of symptoms on 11/13/2020 and had symptoms through 11/29/2020.  I had two visits to urgent care for fluids and medication (11/20/2020 & 11/29/2020).  Exposure came from my husband who presented  with symptoms on 11/12/2020 and contact tracing revealed his exposure was on 11/09/2020
Ears: L and R Eustachian tube swelling; distorted sounds, amplified sounds, felt muffled but loud at the same time; both eyes felt irritated; eye drops for inflammation; This is a spontaneous report from a non-contactable consumer or other non hcp. A 52-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 18Mar2021 at 13:30 (at the age of 52 years), as a single dose for covid-19 immunisation. The patient medical history included allergies of Cipro, Erythromycin and Sulfa. The patient concomitant medications were not reported. Known allergies included Cipro and Erythromycin or Sulfa. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was not received any other medications the patient received within 2 weeks of vaccination. On 20Mar2021, at 08:00 AM, the patient had experienced ears: l and r eustachian tube swelling, distorted sounds, amplified sounds, felt muffled but loud at the same time; both eyes felt irritated then left eye became swollen, red and painful to use the eye muscle. Patient received eye drops as treatment for inflammation. Patient visited to emergency room. The clinical outcome of all events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.