chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Breakthrough Case  Pfizer Dose 1 2/10/21 (EN6201) Pfizer Dose 2 3/6/21 (EN6199) COVID Positive 9/23/21  9/28/21: Patient is an 89-year-old male with past medical history of BPH, hypertension, aortic valve replacement, and arthritis.  He presented to the emergency department on 09/20/2021 with chief complaint of fever and shortness of breath.  Patient has been vaccinated against COVID-19.  He received his 2 shots in February and March of this year. He recently attended a wedding on 09/18/2021.  He believes that he contracted COVID-19 at the event as he began experiencing symptoms 2 or 3 days after.  He was previously tested for COVID-19 and found to be positive.  The patient did receive monoclonal antibodies as an outpatient yesterday.  Following monoclonal antibody infusion, the patient began to feel worse.  He had worsening of shortness of breath and also developed a fever.  He denies any chest pain or symptoms otherwise. He denies alcohol use, tobacco use, or illicit drug use.  Family history is noncontributory.   In the emergency department, patient had a temperature as high as 102.4° F. He was tachypneic and had dyspnea in the ED.  He desatted to 89% on room air as well.  He was requiring BiPAP in order to breathe comfortably given his dyspnea.  However, he did feel that he could probably breathe okay without the BiPAP.  He elected to continue the machine for now as he felt more comfortable while on it. Chest x-ray was concerning for multifocal pneumonia.  Two sets of blood cultures were obtained.  The patient's labs revealed a sodium of 128, troponin of 0.02, hemoglobin of 11.6.  His CRP was 13.90.  He was COVID-19 positive as well.  He was admitted for further management of his COVID-19 pneumonia.  10/13/21: as noted patient required supplemental oxygen as an outpatient was fully vaccinated receive monoclonal antibodies during admission, Decadron, remdesivir, Actemra, Rocephin/azithromycin.  Along with supportive, periodic diuresis with Lasix and nebulizer treatments oxygen requirements gradually weaned down to max of OptiFlow down to 3 L prior to discharge.  Pulmonary assisted during course of admission and cleared patient for dispo to acute rehab.  Can consider anticoagulation once thrombocytopenia improves.  has had precipitous decline in platelet numbers. Lovenox held, hit panel was sent which was negative. Platelets still below 100,000 anticoagulation as noted above is being held possibly due to viral/infectious etiology.  Can consider reinitiate Ng as clinically appropriate at acute rehab.
Labelling Wrong (different strength vs. one on packaging / mispaired - primary); felt like someone punched him in the eyes; splitting headache; soreness all over; He was very sick; bad systemic reaction; Got a full 3rd dose and he is not immunocompromised; full body shivers all night long; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (He was very sick), OCULAR DISCOMFORT (felt like someone punched him in the eyes), VACCINATION COMPLICATION (bad systemic reaction), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION COMPLICATION (He was very sick), VACCINATION COMPLICATION (bad systemic reaction), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and CHILLS (full body shivers all night long). On 25-Oct-2021, the patient experienced OCULAR DISCOMFORT (felt like someone punched him in the eyes), HEADACHE (splitting headache) and MYALGIA (soreness all over). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)). On 25-Oct-2021, CHILLS (full body shivers all night long) outcome was unknown. On 26-Oct-2021, OCULAR DISCOMFORT (felt like someone punched him in the eyes), VACCINATION COMPLICATION (bad systemic reaction), HEADACHE (splitting headache) and MYALGIA (soreness all over) outcome was unknown. At the time of the report, VACCINATION COMPLICATION (He was very sick), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: followup received on 27-oct-2021 and  contains non significant information.
Warm-feeling to the touch swelling, round, red patch on area the size of a half-dollar around injection site.
upper arm itched was red & had raised welt like area the day p/& for approx a week after;
"quite a few vaccinees" experienced "non-response or low antibody titers" following the third dose in the vax series (IM Deltoid).
Rash, red "splotches", puffiness on face & neck, some on legs; fever-(not measured); sx appeared 1hr p/immun given; DPH sx subisided in 3 hrs; MD advised give DT next time;
Took vaccine on November 13th.  I am currently in menopausal.  On November 28th, my menses started again.  This occurred with first vaccine also which I have already reported.
Information has been received from a physician concerning a patient who was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck).  Subsequently the patient developed a rash all over the body.  Unspecified medical attention was sought.  The patient was told to take BENADRYL.  Subsequently, the patient recovered.  No additional information was provided.  There was no product quality complaint involved.  Additional information has been requested.  This is one of several reports from the same source.
headache; nausea; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown".  Additional information: Patient experienced nausea and headache after receiving booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, muscle pain, joint pain, bad headache, fever reaching 101 (I am usually about 97.2)
Idiopathic Thrombocytopenic Purpura, with platelet count dropping to 5k and pt with extensive bruising/petechiae. Pt currently being monitored at home.
Swelling of lips, hives, itching, rash, achy, lethargic. Pt's reaction was several hours after vaccine.
After my second dose I have tightness on the left side of my chest. It's not painful but it's persistent.This is a spontaneous report from a contactable consumer. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 at 15:30 as dose 2, single for covid-19 immunisation. The patient's medical history included asthma. Concomitant medication included escitalopram oxalate and ibuprofen taken for an unspecified indication. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0168, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 03:30 PM as dose 1, single for COVID-19 immunization. The patient had occasional heart palpitations after first dose. Doctor told him to just pay attention to it as long as that wasn't bad. After his second dose on 11May2021 11:00, the patient had tightness on the left side of his chest. That was not painful but was persistent. The outcome of event was not recovered. No follow-up attempts are required. No further information is expected.
Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up my arm .  Some pain and lumps. Fast heart rate
she has been having insomnia; "it's like deadweight; Her left arm is still achy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she has been having insomnia), LIMB DISCOMFORT ("it's like deadweight) and VACCINATION SITE PAIN (Her left arm is still achy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was reported.     On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced INSOMNIA (she has been having insomnia), LIMB DISCOMFORT ("it's like deadweight) and VACCINATION SITE PAIN (Her left arm is still achy). At the time of the report, INSOMNIA (she has been having insomnia), LIMB DISCOMFORT ("it's like deadweight) and VACCINATION SITE PAIN (Her left arm is still achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
No additional adverse events reported; administration of expired VARlVAX; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 24-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #T002848, expiration date: 23-JAN-2022 (route of administration was not provided) for prophylaxis (expired vaccine used). No additional adverse events were reported (no adverse event).
Left shoulder swollen, red with hardness. itching around injection site Taking Aleve and applying ice twice a day since 9/28/21........................as of 9/30/21  still no improvement in condition
Severe hearing loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, couple of months after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received shingrix and after couple of months, experienced severe hearing loss. The reporter mentioned that, they were looking into everything that might had caused it and his inoculations and his travelling in an airplane. The reporter did not provided full demographics or any additional information for this AE and also reported that, the man was reliable and was retired urologist. The reporter did not felt comfortable sharing and does not had AE information for this case. The reporter did not consented to follow up.
Horrible flu symptoms of: Bad Diarrhea, Shivering, Joint Pain like I've never had, odd dreams or mental thoughts, lack of appetite. I was unable to go to work or do anything for 3 full days and had diarrhea for 7 full days. I lost pounds in those 3 days.
Burning Arm pain lasting several days at first. The burning pain continues and is is present now (5 weeks after the treatment). The burning pain recurs when lifting objects above shoulder height. The objects are not heavy an may be as light as 1 Lb causing the burning pain to recur. I'm concerned that this may be permanent as it continues to recur.
Got vaccine while Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Sep-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) had resolved.        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.   Treatment medication was not reported.
The following day she was sitting on her loveseat and she just slid down to the floor, and could not get up.  She had no strength at all in  any of her extremities which lasted all day, from 10:00 AM to 6:00 PM.  Her daughter called and she informed her that she could not get up, and wiggled herself through the house and pulled herself up by the hand of her granddaughter to help her.   It then resolved and she has not had any other problems.  Her arm did hurt for about a week and sore to the touch, but wanted to report that she had the extreme weakness.  She did not consult her doctor, cannot get through to them, been trying for 3 days.
Information has been received from a registered nurse concerning a 50 year old male patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently the patient had a measles titer of 0.00.  He was given a booster of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and the level went to 0.39.  Unspecified medical attention was sought.  Additional information has been requested.
Pt has had left upper arm swelling and pain since the vaccine 7 weeks ago.  Pt is being sent for imaging of the arm.  Results not available yet.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 08-DEC-2015 at time- 04:45, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L0125738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse event were reported. The high temperature and low temperature at which the product was stored were 5.6 and 1.4 (units unspecified) for 6 hours 48 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a female patient of an unknown age 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 an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported. No treatment information was provided. Correspondence contact was ticked and narrative regenerated.
Received first covid vaccine 1/17/21 to the right deltoid (Pfizer, lot #EL3248). On 1/27/21 seen by an APNP for right arm pain and decreased mobility. Presented to EHS on 1/29/21 with pain and concern that vaccine was give posterior to the deltoid. Pt did not take pictures or get seen around the time of her vaccine. So, 12 days later, unable to verify exact placement of the vaccine back on 1/17/21.  Per the APNP's report on 1/27/21, the pt developed sharp shooting pain into the right trap/scapular area and radiation to lower arm. The pain started within a few seconds after the covid-19 vaccine was given. Feels soreness and tension in the shoulder/scapular area which has not resolved since vaccine. Pt advised continue supportive cares, trial diclofenac gel, use oral NSAIDs cautiously, apply heat. Follow up with EMG (scheduled for 4/14/21). Pt was also given a prescription for cyclobenzaprine.  Per documented telephone encounters, as of 2/26/21 pt continues to have significant pain.  Note: Pt received her second covid-19 vaccine on 2/13/21 in her left deltoid and there has been no mention of issues with pain in the left arm (Pfizer, lot #EN5318)
Pfizer Dose 1 3/5/21 (EN6206) Pfizer Dose 2 3/25/21 (ER8732) COVID Positive 1/21/22 1/21/22: Patient is a 73 year old female resident of local long-term care facility. Patient is a poor historian. History was obtained per chart review, ED staff and daughter who is at bedside. Nursing staff noticed that the patient was lethargic in her wheelchair today, unable to support her neck which was deviated to the right side. Has not been eating or drinking for the past several days. Patient's daughter stated that she has had a progressive decline in her health since her last hospital admission on 12/1. She was seen by her PCP on 01/04 with concerns of worsening confusion and disorientation. Infectious and metabolic workup was unremarkable. The patient does have a chronic meningioma, PCP ordered CT scan determine if there has been any changes, meningioma remains stable. Patient was seen and examined in ED. She responds to her name, which per family is her baseline. She is unable to follow commands or answer questions appropriately. She has a past medical history of schizophrenia, dementia, asthma/COPD, tobacco use and hyperlipidemia. On arrival to ED the patient was hypertensive 156/82. Laboratory findings were significant for hypernatremia 151. Hypokalemia 3.4. Urinalysis WBC 11-30. IV Rocephin 1 g given in ED. IV hydration given with NS 0.9% 1 L bolus. 2/9/22: Comfort measures per family's request. Will discharge to hospice facility. Discussed with care coordination
Moderna COVID-19 Vaccine  Symptons / side effects began approximately 18 hours after injection and lasted approximately 24 hours,  They included injection site tenderness and redness, fatigue, headache, chills and fever (100.6).
Nystagmus (horizontal, bilateral) noted by parents about 4 days after vaccines administered. Had son at that time on Zyrtec, scheduled for tubes (placed 08/15/2005) with no sign improvement noted after tubes put in. Has seen his ENT and Ophtro, Pedi neuro also.
Had aches, chills, low grade fever for 36 hours. Started Thursday night after the shot that morning and lasted till Saturday morning. Got up Saturday morning and felt fine.
pins and needles left side of face, pins and needles right arm and hand, pins and needled left arm and hand. Ongoing
NAUSEA STARTED WITHIN 1 OR 2 MINUTES AFTER LAST VACCINATION. THEN PT FAINTED DUE TO HYPOTENSION SECOND TO ANXIETY. HE WAS SWEATING, CLAMMY FEELING AND COLD.
The pt experienced redness, warmth, swollen and pain on right deltoid. Temp of 103.5 and pulse of 114, nausea 12 hours post vax. The pt was hospitalized for 4 days and on IV antibiotics. Per F/U 3/21/02: Admitting dx: cellulitis. Discharge dx: right upper extremity cellulitis, initially treated with IV Kefzol and she defervesced. The pt will continue on po Keflex X 14 days. The pt also had GERD. She initially complained of substernal chest pain which became epigastric in nature but it had improved with Maalox. The pt had been on Prevacid 15mg po a day but this was increased to 30mg po a day. She also was dx'd with anemia with an iron deficiency with some element of bone marrow suppression. In a pt this age, it is reasonable for her to receive a colonoscopy to rule out malignancy. We started her on iron sulfate tablets to be increased to 375mg po tid over the ensuing 2 weeks. Initially the pt was placed on Glucotrol, 10mg only while her metformin was held. Metformin was re-started on hospital day 3. Her blood sugar levels remained in the 80's to 170 range. The pt was noted to have protein in her urine. She may benefit from an Ace inhibitor.
I woke up after an hour of sleep with violent chills and shaking and an overall feeling of weakness similar to bad flu.  The 'illness' only lasted about 24 hours.  I also had an outbreak of hives for the first time in my life 1-2 months later which lasted for 2 horrible weeks.  No way to know that it was related though.  This was my first ever flu shot that I know of.
Left arm swelled & was hot around injection site that lasted for about a day. Then 2 days later patient developed nerve pain up & down her arm which she has had for 2 weeks now & is still experiencing. Dr told her she will have pain until nerve heals, could be 6 weeks. Her PCP told her to take 2 ALEVE twice a day and on 10/31 he told her to go down to 1 twice a day for 2 weeks & to call him back.