chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of difficulty breathing in a 5-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On 28 July 2009 the subject received 2nd dose of HAVRIX at 0.5 ml (720 elisa units). At an unspecified time after vaccination with HAVRIX, the subject was taken to the emergency room due to wheezing and difficulty breathing. The reporting nurse indicated that a small infiltrate in the right lung was noted. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The child was not hospitalized. At the time of reporting the events were resolved. It was stated that the child had no reaction following the first injection with HAVRIX.
On 5/20/00, same day as vax at 13:00, pt experienced lightheadedness, diarrhea, chills, vomiting for 16 hours. Pt also complained of chest congestion for 2 weeks post vax, still present.
Flu shot at 7:30pm. severe diarrhea onset 7:30 am next morning. vomiting and fainting spell late that nite. Went to ER for IV and nausea medicine. Fever up to 102 was dehydrated but blood Chem was ok, low salts.
about 10 min after the injection as I was sitting in the waiting area I got a hot feeling come over me and I felt the color drain from my face and I felt like I was going to "pass out" it passed after about 15 seconds and I felt fine. I waited 30 min from vaccine time to make sure I was going to be ok. At 5:30 pm on 1/6/21 I noticed I stared itching my right arm around the inside of the elbow. I noticed my vision blurring and I had a sudden onset of a Horrific headache. By 6 pm I was itching very severely. It was as if I was clawing at my skin. I called one of the dr's I  work with and he called me in a medrol dose pack. I started the dose pack at 8:30 pm on the 6th. The headache continued, I tried motrin, fiorcet, and oxycodone with no relief. I still have the headache but it is not as intense as it was. I was up all night itching and dealing with the headache by the am , my jaw was  visibly swollen and it felt like I had been in a fight. I was not able to go to work on 1/7/21 and could only work 1/2 day on 1/8/21. the itching did not subside much till sat 1/9 but is coming back as I  taper down off the steroids. My last pill was this am. The jaw pain and swelling lasted till sat night and is subsiding daily. I may have to call my pcp and be seen this week.
Breakthrough case after Covid vaccination. Dose #1 03/12/2021, dose #2 04/09/2021 C/O loss of taste/smell, SOA, and cough
Pt reported "medicine taste" in mouth within 1 minute of vaccine administration. Pt then reported nausea and dizziness within 3 minutes. Pt placed in sidelying position and allowed to rest with medical professionals immediately available. Blood glucose 184. Pt denied eating or drinking since waking. Pt reported improvement around 9:25am, orthostatics obtained - WNL. Geri-Lanta administered for nausea. Pt ambulated safely from clinic at 09:45.
Sore arm; Numbing in arm vaccine was received; Nausea; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPOAESTHESIA (Numbing in arm vaccine was received), NAUSEA (Nausea) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPOAESTHESIA (Numbing in arm vaccine was received), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPOAESTHESIA (Numbing in arm vaccine was received), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Off-label use; COVID 19; Booster; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (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: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "hypertension" (unspecified if ongoing), notes: other medical history: hypertension; "hypercholesterol" (unspecified if ongoing), notes: other medical history: hypercholesterol. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy:Codeine", notes: Known allergies: Codeine.  The following information was reported: IMMUNISATION (medically significant) with onset Apr2022, outcome "unknown", described as "Booster"; COVID-19 (medically significant) with onset Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19"; OFF LABEL USE (medically significant), outcome "unknown", described as "Off-label use". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of off label use, immunisation, covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
EAR AND LEFT SIDE SKULL PAIN STARTING 02/15/22  2/19/22 LEFT SIDE FACE PARALYSIS.  IMMEDIATE TRIP TO ER RESULTING IN BELL'S PALSY DIAGONISIS WHICH MAY LAST WEEKS, MONTHS OR YEARS IMMEDIATE TREATMENT INCLUDED ANTIVIRAL AND STERIODS FOLLOW UP TREATMENT 2/22/22 - LEFT SIDE JAW AND FACE PAIN  3/11/22 - GP PRESCRIBED GABAPENTIN FOR NERVE PAIN 3/14/22 - NUROLOGIST CONSULT  3/15/22 - OPTHOMOLIGIST FOR EYE SWELLING - BEGIN TO MONTIOR FOR EYE DAMAGE   OUTCOME STILL PARALIZED ON LEFT SIDE OF FACE
Pt. received pediatric dose of Hep B instead of adult dose. Pt. did not experience any adverse reactions.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: tingling of arms/hands
blotchy red areas on various parts of body, slightly itchy.  Resolved after a couple days
Woke up at 8am with Sudden Hearing Loss in left ear 4 days after booster. Currently being treated by Dr.
swollen lymph nodes; Compared to yesterday, It is worse, more painful; It felt very warm; I was rubbing and I noticed the node; pain in left arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FEELING HOT (It felt very warm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (It felt very warm). At the time of the report, FEELING HOT (It felt very warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
missed period 2/17/2021 with NEG urine preg test. was breastfeeding 11 month old baby.  received 2nd Pfz vacc 2/18/2021; Pos urine preg 2/22/2021. Confirmed PREG at OBGYN exam with usg and heart beat in March 2021.  No heart beat at routine exam 4/15/2021; D&C 4/16/2021. gestation 11 weeks; baby measured 9 weeks gestation. pregnancy #6. 4 healthy children. 1 previous miscarriage in 2015 after Tamiflu in the periconception time.
Patient developed a dark rash surrounding injection area of left arm on 3/22 and she went to the ER and was given Benadryl (tablet) and 3 tablets of Prednisone. After treatment condition improved.
within a few seconds of administering MMR, noted Pt. saying it was burning- noted small blistering started to appear directly below where imm was administered. Ice applied- denied initially any issues with breathing- as time progressed, states she was dizzy- laid on floor immediately and elevated feet- V/S were taken and other nurses in room to help with documentation and med administration- states B/P was on the low side, decision made to admin. 1 ml of Benadryl to help allergic reaction admin.  this was done at 11:44 AM. rash became worse- more of a " large hive", states she started hyperventilating and was having some s/s of anxiety and states it was starting to feel like " she just climbed a mountain and was having issues breathing about 12:11PM- 911 was called to be in route- prior to giving epinephrine. admin. 0.5 ml and paramedics and fire arrived to assess and decision  to transport to hospital at 12:43 PM
Patient was somewhat nervous during the immunization. Seemed ok when leaving the pharmacy, but started feeling nauseous and lost vision quickly after. Patient fainted, but immediately came to.
Weakness on the first day Diarrhea, weakness, chills, and weight loss the day after and ever since
Horrible body aches, headache and chills for 12 hours.  The following day I had  horrible and painful shingles outbreak.
15FEB pt became ill cold like sx; t103 3AM lower limbs stiffness; 1015 ER comatase, listless, tonic posturing, decerebrate posturing of fore arms; WBC 22,000; BUN 33; P202-602;
Fever, muscles aches, headache, multiple episodes of vomiting, arm pain, fatigue
Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 03/16/2021. Patient was hospitalized from 09/03/21 - 09/11/21. Below is copied from discharge summary:   Pt. is a 58 y.o. male with a history of hypertension presented to the emergency department with complaints worsening shortness of breath and hypoxia.  The patient began experiencing symptoms on August 27th and tested positive for COVID-19 August 28th.  The patient saw his personal care physician on August 31st and was given dexamethasone, albuterol and a antitussives.  The patient received Regeneron on September 1st and briefly felt better but by a early Thursday morning the patient worsened.  The patient's symptoms have included progressively worsening shortness of breath, cough with blood-tinged sputum x1 day, sharp anterior chest pain when coughing, decreased appetite, fatigue, fevers, nonbloody diarrhea.  The patient's wife had recently bought a SpO2 monitor and today the patient had home oxygen level 56 percent on room air.  Patient therefore came to this facility for further evaluation and treatment.  The patient is denying orthopnea, pedal edema, loss of taste or smell, headaches, visual disturbances, focal weakness, ataxia, myalgias, arthralgias, abdominal pain, blood in urine or stool, constipation, rashes or trauma. Patient has received the COVID-19 vaccinations.
Pt received pneumonia shot approximately 8 AM (10-13-10). In evening of same day she had large amount of soreness, redness, and swelling from shoulder down to elbow.
Pt states that within a few hours of receiving the high-dose INFLUENZA vaccine he stated having cold symptoms - cough and congestion. States it is "mild" and denies sore throat or difficulty breathing.
Patient with history of DVT and PE (2010) on chronic anticoagulation with presentation of new superficial blood clot of greater saphenous vein of left leg while on therapeutic dose of Xarelto on 4/7/2021. Was evaluated by hematologist.
I am a physician.  About 3 hours after injection of 2nd dose, I had rigors, severe upper abdominal crampy pain, severe nausea, and aches in all of my joints.  This acute phase almost took me to the ER for relief of pain and misery, and lasted about 3 days.  Subsequently, I had less nausea and abdominal pain, though the exact symptoms occur at a reduced level chronically.  My joints continued to ache, and my IP joints became very swollen, and some erythematous (3 - 5 were the worse effected).  The lateral aspects of all of my phalanges were exquisitely tender to very light touch.  I could not fully bend my fingers, and the joints became distorted.  My fingers have been the most effected, though my ankles and toes hurt also.  The pain and swelling was NOT related to the time of day.  After about 12 to 16 weeks, I tried to see a rheumatologist, but was told they have a several month wait (spoke with a doctor, and told her I am a surgeon unable to work).  I never got an appointment (there are lots of elderly).  Concerned about joint destruction, I went to an outpatient facility pain clinic.  Not ideal, but the doctor and nurse were very kind and accommodating.  I was treated with IV infusion of steroids and ketamine.  I had remarkable improvement after 1 treatment.  I had 3 additional treatments.  I still suffer from joint pain, nausea, and upper abdominal pain.  I have never had auto immune illness, and not a single person in my entire family had a joint replacement.  The first dose did not make me ill, this second dose changed my life and ability to work, so far, permanently.
minor pain / soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor pain / soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN HCL, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), FOSINOPRIL, ROSUVASTATIN, TROSPIUM CHLORIDE, SERTRALINE, ANASTROZOLE, AMLODIPINE, MAGNESIUM, ZINC, COLECALCIFEROL (D3), CYANOCOBALAMIN (B12-VITAMIIN) and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (minor pain / soreness). At the time of the report, PAIN (minor pain / soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-382531, MOD-2021-381883 (Patient Link).
Usual tiredness & adverse effect on PRN medication. I take sumatriptan for onset of migraine attacks. Ever since I received the 1st dose on 1/22/21, when I take this medication, my face starts to itch & has a tingling sensation (pins & needles feeling). I have been taking this medication for 10yrs & not once have I ever had this kind of reaction. I am a little scared.
increased joint inflation in my hands and my feet; increased joint inflation in my hands and my feet; accelerated my arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 16:15 (Lot number: ER8729) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "joint inflation in my hands and my feet" (unspecified if ongoing), notes: I have increased joint inflation in my hands and my feet.; "arthritis" (unspecified if ongoing), notes: It seems to have accelerated my arthritis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0172, Administration time: 15:45 pm, Vaccine location: Left arm), administration date: 09Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 04May2021 07:00, outcome "not recovered" and all described as "increased joint inflation in my hands and my feet"; ARTHRITIS (non-serious) with onset 04May2021 07:00, outcome "not recovered", described as "accelerated my arthritis". The events "increased joint inflation in my hands and my feet", "increased joint inflation in my hands and my feet" and "accelerated my arthritis" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthritis, condition aggravated, arthritis.  Additional information: The patient did not have any known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had increased joint inflation in his hands and his feet. It seems to have accelerated his arthritis. He didn't have these symptoms until about a week after his second Pfizer dose. The case was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Headache, fever, elevated heart rate, dizziness, nausea for 36 hours.
Within 15 minutes, the right side (the side where I got the shot) of my head started feeling mildly numb and heavy. As if I was given local anesthesia and the effects were wearing off.  Within 1 hour, I had very mild stiffness on the right side of my neck/shoulder bridge.  It's been 18 hours now since I received my booster. The symptoms persist and I am not sure if I should visit the hospital. Please let me know if I should.
Patient had received his flu shot, covered site with fingers and a drop of blood came out. Covered with bandaid. Administered Covid booster, applied bandage. Disposed of sharps and noticed patient went pale. Tonic movements and loss of consciousness noted. Patient slumped over onto his right side. Author said his name, and he woke up within 10-15 seconds. Assisted him onto bed to lie down. Monitored him for over 20 minutes, symptoms improved. Stated he has had syncopal episodes while giving blood only.
Dizzy, Faint, heart racing, tachycardia, headache. Patent says they were diagnosed with POTS or dysautonomia.
Fatigue, headache, diarrhea, arm soreness, swollen glands, ear infection, sore throat, muscle aches-- started two days after and is still occurring on day five
This was my daughters second shot. She experienced 90 minutes of uncontrollable shaking around midnight with whole body. Also, with headache and overall body aches and hot and cold spells.
pt vomited @ daycare & apparently had resp arrest; code red began in daycare & pt transported to hosp ER where resusitation was unsuccessful;
Patient requested shingles vaccine. RPH looked up pt hx and had no TDAP hx. RPH asked pt if he'd like TDAP, patient agreed. Before administering TDAP RPH again reminded patient he was getting TDAP and patient agreed. after administration patient said "I think I already got this". Checked enterprise rx software and it stated patient had in fact gotten it on 10/17/2020. explained situation to the patient and how it would not have any medical issues but to call us if they had any concerns. Patient understood and was okay.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 40 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-JUL-2021, the patient was tested positive for COVID-19 (suspected COVID-19 infection and suspected clinical vaccination failure). The patient was close to someone who had COVID-19 with mild symptoms of a runny nose and cough. The symptoms were mild and patient got tested because she had children at home.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected COVID-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738685-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 013M20A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-434942 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-434942:Female patient (Vaccination site pain) Same reporter
Light headed, at night it feels like no blood circulation in his left arm. When he stands up his heart rate goes up, he has trouble breathing and now he is having anxiety issues. Went to the ER
Pt vaccinated with DTP/MMR developed temp of 102, very sore & painful rt arm. Tired & listless.
Measles-like rash from knees to the neck. Took Benadryl and levocetirizine. Still not resolved.
Severe achy pain  in joints, head, ears, arm, neck and upper back.  Chills but no fever. Chill accompanied by waves of achy pain all night...8 hrs ...could not sleep.  Next day waves subsided but still achy all over with bad sinus headache.