chrisvoncsefalvay/vaers-outcomes huggingface dataset:
boosted adult traveler acquired COVID-19 after returning home from traveling; boosted adult traveler acquired COVID-19 after returning home from traveling; Dose 1/Dose 2 bnt162b2, Dose 3 mRNA-1273; This is a literature report for the following literature source(s):  An adult patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; mrna 1273 (MRNA 1273), on 20Dec2021 as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Dec2021, outcome "unknown", described as "Dose 1/Dose 2 bnt162b2, Dose 3 mRNA-1273"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as " boosted adult traveler acquired COVID-19 after  returning home from traveling". Clinical courses: Boosted adult traveler acquired COVID-19 after returning home from traveling and were treated with NM/r 300/100 mg taken orally twice daily for 5 days. The patient experienced initial improvement with NM/r followed by rebounding symptoms.  Progressively worsening fatigue, sore throat, nasal congestion, and diarrhea were associated with high viral shedding (cycle threshold = 21.7) and culturable virus 5 days after the NM/r course. The patient underwent the following laboratory tests and procedures: viral shedding: high, notes: cycle threshold = 21.7; Gene sequencing: SARS-CoV2 BA.2 lineage strain PRSD01, notes: Sequence comparison to the BA.2 reference showed no amino acid differences in any coding region, including ORF1a and spike protein; Nasopharyngeal swab: isolated SARS-CoV-2; SARS-CoV-2 antibody test: evaluated the susceptibility of the viral panel to, notes: to the neutralizing antibody response in the plasma from the patient. The average half-maximal authentic virus-neutralizing antibody concentrations against BA.2 PRSD01, BA.1, and parental were 1668, 1170, and 5239, respectively; The half-maximal inhibitory concentrations (IC50), notes: of NM against BA.2 PRSD01 were 2.0-, 1.8-, 1.7-, and 2.0-fold lower than the parental, Delta, BA.1, and BA.2.3 strains, respectively. The remdesivir IC50 for BA.2 PRSD01 was 2.0, 1.8, 1.1, and 1.3 times higher than the parental, Delta, BA.1, and BA.2.3 strains, respectively; Culture: culturable virus 5 days after the NM/r course. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Patient developed hive type reaction after receiving the 2004 influenza vaccine. Seen in ER and treated with Solumedrol and Benadryl. No sequelae. Allergy updated. Dx allergic reaction possible reaction to flu vaccine.
Headache (ongoing), Muscle soreness (ongoing), Swollen lymph node in left armpit (started on 5/9), nausea (when I woke up on the 8th), chills, elevated resting heart rate (around 100 BPM)
jittery feeling in chest on and off; Nausea; Left hand tingle; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (jittery feeling in chest on and off), NAUSEA (Nausea) and PARAESTHESIA (Left hand tingle) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (jittery feeling in chest on and off), NAUSEA (Nausea) and PARAESTHESIA (Left hand tingle). At the time of the report, ANXIETY (jittery feeling in chest on and off), NAUSEA (Nausea) and PARAESTHESIA (Left hand tingle) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): increased mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   Reporter did not allow further contact
Arm felt sore and started a migraine like headache withing 30 mins Took a painkiller at the start of the next day....on the 3rd day, lymph nodes at the armpits were swollen and painful and  got numerous boils on the trunk of my body and back, that were very red, sore, sensitive to touch, and very painful(looked up the net and it resembled shingles). This was the case for about 2 weeks, and then the pain started easing and scabs started forming on the boils, still have the scars
incredible lethargic; The mole appeared about a half week after my second vaccine; site of injection on my arm was now raised and slightly discolored; site of injection on my arm was now raised and slightly discolored; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in 2021 as dose 2, single (at the age of 23-years-old) for COVID-19 immunisation. Medical history included Loeys Dietz syndrome, heart surgery 4 years ago, blind in one eye. Concomitant medications included mirtazapine, guanfacine, losartan and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), all medications received in two weeks, taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6199), via an unspecified route of administered in left arm on 10Mar2021 at 11:30 am (at the age of 23-years-old) as dose 1, single (at the age of 23-years-old) for COVID-19 immunisation and the patient had Incredibly nauseous, Throwing up and had a terrible migraine. The patient was not pregnant at time of vaccination. Th patient was not received other vaccine in four weeks. The patient was not received covid prior vaccination. The patient has not been tested covid post vaccination. It was reported that the day after her second vaccine in 2021, she was incredible lethargic. The site of injection on her arm was now raised and slightly discolored, it looks like a mole. The mole appeared about a half week after my second vaccine. No treatment was received for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About hour after injection both hands started itching and scratching wouldn't go away. I went to two different Dermatologist my skin was bubbly and super dry. I was given lotions by the doctor my skin started to peel.
8 days after receiving Pneumovax and 5 weeks after receiving flu vaccine, developed horrific pain in left upper arm. Pain was in there and continued. 1 week later developed same pain in my right arm. 1/5/03 developed wrist drop right wrist. Referred to neurosurgeon for bulging disk C-7 which he thought was causing wrist drop. 1/16/03 had cervical diskectomy with graft and plate. This surgery did not improve left wrist drop or right arm weakness. 2 months later i deveeloped severe weakness in my left arm. I was re-hospitalized and had a bone scan, MRI of brachial plexus, MRI; all of these tests were negative. The diagnosis I was given at discharge was Brachial Pleuropathy with unusual presentation. I was then referred to another clinic. I had EMG's, spinal tap, blood work. They could find no reason for the condition I was in except for a possible reaction to one of the vaccines I received. They gave me a diagnosis of Bilateral Parsonage-Turner Syndrome. In March, I was told I have a left paralyzed diaphragm. I am now facing surgery on my left shoulder for rotator cuff tear (8/18/03). Orthopedist felt was possible due to the neuritis. I had been healthy and working up until 5/03 when I developed the wrist drop and arm weakness. Medical record states degenerative jt dx, shotty nodes, atelectasis, neuropathy, numbness, spinal stenosis, and SOB.
There was no adverse reaction. Patient was just given an extra dose of MMR. Provider was notified right after incident, patient was okay. Mom was also made aware this happened right after incident.
No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe) (lot# T008698, was established as valid, with expiration date: 04-JUN-2021) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursions were reported. A digital data logger was involved. No additional adverse effects were reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA010267: US-009507513-2007USA010269: US-009507513-2007USA010268:
Tested positive for Covid on 09/08/2021. I had Coughing and congestion. The congestion started going down into chest and I did have a severe case of bronchitis that turned into walking pneumonia in 2010 due to overwork. I was concerned about the possibility of Covid influenced pneumonia. No fever, no pulse oxygenation, copious amounts of drainage were all clear, lots of congestion, gunk going down and the beginning of congestion and coughing up from the upper respiratory tract. No muscle aches. I did receive monoclonal antibodies on September 10 and symptoms started getting better.
Presents to virtual urgent care today with a macular papular rash and significant pruritus over her arms and legs.  She states this started on Sunday as some itchiness and then the rash has progressed.  Patient denies any facial swelling, tongue swelling, throat swelling, difficulty swallowing or difficulty breathing.  She has been using Claritin, Zyrtec, Benadryl, and topical cortisone cream with no significant improvement.  There is no fevers chills or body aches.   Received 2nd dose of pfizer covid vaccine on friday march 12. Advised to continue OTC treatment and monitor for improvement.
Extreme pain at injection site within 24 hours. By the next morning, my whole right arm was screaming in pain (nerve, muscular). Felt physically ill and vomitted a few times. Went back to the same urgent care and they prescribed me with prednisone 5 day treatment at 40mg. I slowly felt better over a couple of days until I felt the pain spread to my left arm, then legs, and now 4 months later, my whole body. The pain turned into joint and muscle and nerve pain, jumping around my body at different times. No pain medicines work, and steroid prednisone does not work anymore. The pain has been slowly subsiding but for these several months I have seen specialists, had a handful of blood panels done, and nothing turned up.
pt recv ax 23FEB96 & 15APR97 pt devel mild chickenpox;pt recovered from sx by 22APR97;
RIght leg pain started 7/12, swelling noted 7/15. ED visit 7/17 with hospitalization overnight for anticoagulation. Dx of large clot in right leg veins, small bilateral PEs.
pancreatitis, elevated liver enzymes, not drinker, triglycerides not elevated, no stones found
Swelling, redness of left arm, fever after IM Dtap injection. Taken to ER 5/16/06. Followed up with Dr on 5/17/06. Given cephalexin 250mg 4 x day. On 5/19/06. Grandmother says she is doing much better.
8 days after booster experienced severe hives and itching in patches all over body that would come and go. Back of the head and neck, groin, back, arms, and hips were all particularly bad. Overall worse in the evening and if something rough was rubbing/touching that area. Chronic urticaria and pruritus ever since. Mild most of the time with some bad flare-ups every few days.
Patient does not report to the pharmacy until Nov 12,2015. Patient stated that she has pain on the arms and the pain is very painful like she had never had before.
Guillain Barre Syndrome; Initial information was received on 15-Oct-2020 regarding an unsolicited valid serious social media case from the consumer (patient's wife).   This case involves a male patient (age was not reported) who had Guillain Barre syndrome, while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious Guillain Barre syndrome, (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Reporter stated that use of vaccine make person ill for several years to the point that the person wish, he/she could die to stop the constant suffering. It didn't save her husband's life, it almost killed him.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented case concerns a patient of unknown age who developed Guillain Barre syndrome, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Moderna COVID-19 Vaccine: Got vaccine 12/28/20.had some swelling at injection site. Seemed to be gone for the most part in couple of day. One week later began redness, swelling, pain, itching at injection site. Continued to increase. Today 1/6/21 site still swelling up. Site redness and swelling measures about 3 in by 3 1/2 in. Using warm compresses and icing .
Achy joints and muscles, fatigue, nausea, diarrhea, hot flashes, and headache.
On 6/29/22, staff notified from IIP that pt received 12+ dose of Pfizer vaccine instead of 5-11 year dose. At time of initial vaccination, pt was observed x15 minutes after vaccination without incident. At follow up on 6/22/22, pt reported he had no issues with first dose of vaccine. When family notified of event, dad stated that pt had no issues with vaccines and was feeling great. Dad stated that pt is large for his age and felt the larger dose of vaccine was probably more beneficial for pt.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/20/21 2nd dose01/10/21 Diagnosed covid positive:09/15/21 Symptom onset:09/13/21 Exposure:home Symptoms:cough,fatigue,muscleaches
pt recvd vax;  3 days later pt exp itching which persisted for several hrs;
Provider hospital summary "Patient is a 85-year-old male with a past medical history of coronary artery disease, heart failure with reduced ejection fraction, Parkinson's disease, hypertension admitted with respiratory failure due to COVID pneumonia.    Brief Summary of Hospital Stay:  He did require high-flow nasal cannula at 1 point he completed a course of remdesivir and Decadron.  He also developed a STEMI and was seen by Cardiology.  He had PCI with DES on 12/03.  He has been started on goal-directed therapy per cardiology's direction including beta-blocker, aspirin, Plavix, Zocor, Ranexa, nitroglycerin.  He did develop 2 episodes of atrial fibrillation which converted spontaneously, follow likely due to his acute illness COVID infection.  Cardiology never did comment on this.  At this time the risk of anticoagulation exceeds the benefit, with risks including high bleeding risk while already on Plavix, Ranexa, and aspirin, fall risk.  It is quite possible that the atrial fibrillation was transitory, nevertheless I have ordered an event monitor to be sent to his cardiologist.  I will defer further management decisions to Dr. (Privacy) and Cardiology team.   At this time the patient has been weaned to room air, a walker has been provided.  The patient has a normocytic anemia which will need to be monitored to normalization."
No adverse effects reported; improperly stored doses of VARIVAX was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 12-APR-2019, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R027993 and expiration date 01-OCT-2020)  (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA006081: US-009507513-1905USA010082: US-009507513-1905USA010080: US-009507513-1905USA010081: US-009507513-1905USA010092: US-009507513-1905USA010085:
The vial drawn from was the Pfizer bivalent booster for 6 mo. to 5 years.  0.3 ml was drawn up and administered without diluting (as you would for a child, and giving the lesser dose of 0.2 ml).  Patient notified by telephone call that this undiluted dose is adequate as a vaccination for the Pfizer bivalent booster vaccine.
left side of face swelling, especially left eye area and around left side of mouth; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EKG9231, expiration date: not reported), via an unspecified route of administration, on 12Jan2021 10:00 AM on left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at a hospital. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gerd (Gastroesophageal reflux disease) and allergy to grapefruit. Concomitant medication included esomeprazole magnesium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: Elo 140, expiration date: not reported), via an unspecified route of administration, on 23Dec2020 09:00 AM on left arm for COVID-19 immunization. The patient experienced left side of face swelling, especially left eye area and around left side of mouth, on 13Jan2021 11:00 PM. Since the vaccination, the patient has been tested for COVID-19: Nasal swab on 01Oct2020 (as reported) with negative result. The treatment received for the adverse event was Otc (over-the-counter) Benadryl. Outcome of the event was recovering.
SEVERAL DAYS AFTER RECEIVING THE FIRST DOSE OF PFIZER VACCINE I STARTED HAVING INTERMITTENT "FLUTTERING AND PRESSURE IN MY CHEST".  THIS KEPT GETTING PROGRESSIVELY WORSE UNTIL FINALLY I WENT TO AN URGENT CARE/ER FACILITY  IT IS HARD TO TELL IF THE LOT NUMBER HANDWRITTEN ON MY VACCINATION CARD STARTS WITH AN "F" OR A "T"
For 2 days I have been cramping hard enough to think Im going to start; bloating and the pains are soo bad I feel like my insides are going to fall out; bloating and the pains are soo bad I feel like my insides are going to fall out/dull full ache going from front to my back; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 4989177-06755), via an unspecified route of administration, administered in Arm Right on 21Oct2021 10:15 (at the age of 53-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ibuprofen (MOTRIN), cetirizine hydrochloride (CITIRIZINE) both taken for an unspecified indication, start and stop date were not reported. There were no known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 4978916-06755), via an unspecified route of administration, administered in Arm Right on 30Sep2021 20:45 (at the age of 53-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient stated that she has been in post menopause for 6 years with no spotting or bleeding or cramping in all this time. For 2 days (from 26Oct2021 06:00) she has been cramping hard enough to think she was going to start. No spotting or bleeding but bloating and the pains were so bad she felt like her insides were going to fall out. Motrin helped for a little bit, but the pain was still there, dull full ache going from front to her back. The patient did not receive any treatment for adverse events. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Passed out; Felt tired; A spontaneous case report was received from a consumer concerning an 80 years-old female patient who experienced passed out (MedDRA PT: loss of consciousness) and felt tired (MedDRA PT: fatigue)  The patient's medical history included cancer. Concomitant product use included chemotherapy and other medications (not specified).   The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on an unknown date. On 16 Feb 2021, approximately one day prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #011M20A) intramuscularly in an unspecified site for prophylaxis of COVID-19 infection.  On 17 Feb 2021, one day after receiving the vaccination, the patient felt tired and passed out. The patient inquired if this was a normal side effect.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events passed out and felt tired is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.