chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1615  vaccine given Patient and guardian came in as a walk-in patient for 1st dose. Patient is 4yrs old. This nurse notified pharmacy what available vaccine we have for a 4yrs old with no prior dose of covid vaccine. Moderna bivalent vaccine is available. Pharmacist came in to the vaccine room and handed over moderna bivalent pink cap and this nurse, verified if it?s the right one.  I specified it is the first vaccine of the patient and no prior history of other doses. After giving 0.2ML moderna bivalent pink cap to patient.  The Pharmacist reached out to me saying she is on the phone with other Pharmacist, and that the vaccine that I gave was wrong and it should be moderna bivalent blue cap 0.25ML and patient would come back 4-8wks for 2nd dose. PCP provider notified by Pharmacist. Pharmacist, also mentioned that other Pharmacist. will be calling moderna to clarify the moderna mis- dose plan and what would be the next step. Patient is not having a reaction, no side effects.
Swollen area around tetanus injection site.  Area grew to 5 inches in dia.
blood clots in her lungs; getting out of breath; couldn't walk very far; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far). On 01-Apr-2021, the patient experienced PULMONARY EMBOLISM (blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Apr-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clots in her lungs), DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown unknown. On an unknown date, Computerised tomogram: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown unknown.         No concomitant medications were reported. She was admitted to the hospital on 01/Apr/2021 and had many tests which included bloodwork and a magnetic resonance imaging scan (MRI) or computed tomography (CAT) scan. They found blood clots in her lungs.  Company Comment: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Flu-like symptoms - fever, body aches/pain, nausea and vomiting for 2 days.
Patient complained of bruising around injection site, moving to side of left arm, about baseball size blue/purple color. No pain or inflammation.
Pt. states that after receiving the 3rd dose of Phizer 12/07/2021, started experiencing symptoms 12/08/2021 of swelling in the (Left) lymphnoid and slight pain. Primary visit 12/13/2021 Blood Work = Anemia. Ultrasound Appt. 12/31/2021. Pt. still continuing to experience symptoms.
Fever inj site pain, fever, aches, chills, fatigue x 2 days Narrative:
Large welts throughout torso. Diagnosed as Pityriasis Rosea by Dermatologist.
Narrative: Patient sent to emergency room for cardiac workup. In the ER, patient states all symptoms resolved prior to any intervention. Patient left AMA after 1st troponin was negative, provider wanting a second troponin but patient refused.
Pt recv vax on 12/5/97; on 12/6/97 pt exp pain, tenderness &swelling in her left cheek;trouble opening mouth &obscuring angle of jaw.  M.D. reported pt looked to have mumps parotitis; pt quarantined for 9 day.
patient reported tightness/stiffness in neck region, tingling tongue, discomfort in back of throat that progressed over course of 30 minutes, administered 50mg diphenhydramine 10 minutes post vaccination, alerted EMS to have patient checked out
HIGHER THAN RECOMMENDED DOSE OF VACCINE WAS ADMINISTERED PATIENT HAD RECEPIVED UPTO 180MCG DOSE INSTEAD OF 30MCG. VIAL DILUTION WAS NOT DONE
Initial report received from a health care professional on 23 October 2012. A 53-year-old female patient with no relevant medical history and no illness at the time of vaccination, had received an intramuscular dose of FLUZONE in left deltoid on 03 October 2012 (Lot number UH732AA). On 03 October 2012 i.e. 03 hours after receiving vaccine the patient had developed "body wide pruritus" which was without rash. At the time of report laboratory investigations were unknown. As corrective medication the patient received BENADRYL orally on unspecified date. The patient was recovered on the same day i.e. on 03 October 2012. Documents held by sender: None.
Information has been received from a pharmacy technician concerning a female patient, "in her mid-50's", who was vaccinated at a pharmacy, with a dose of Pneumovax 23 (lot #651322/1044P).  Three days later she returned to the pharmacy with a swollen and red injection site reaction.  The area below the injection site was red and "lifted" but not sore.  Unspecified medical attention was sought.  It was unknown if this was a revaccination.  At the time of report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
"Uncontrollable shaking and tenseness"; "Uncontrollable shaking and tenseness"; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included calcium carbonate, magnesium carbonate (TUMS) and paracetamol (TYLENOL). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, the patient experienced uncontrollable shaking and tenseness and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL. The clinical outcome of the events "uncontrollable shaking and tenseness" and chills were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Swelling of the left arm associated with pain/tenderness. Swelling with erythema is about 5x3in in size, slight left sided chest discomfort. Treatment, antihistamine, ibuprofen and prednisone.
Fever, body aches, headache, chills, fatigue, don?t feel well, joint pain
Unable to raise my arm by evening, very painful and couldn't sleep on that side. It's a lot better but still difficult to raise in certain positions, seems to be in the joint??
Gave immunization too early. No adverse event took place. 2nd Hep A dose was received 3 months too early.
Patient came in with father to receive first dose of COVID 19 vaccine (Moderna) this morning. While screening the patient, patient mentioned that she gets flu vaccines each year but this past year her arm had severe swelling after a flu vaccination where she was placed on steroid therapy. Pharmacist suggested that patient receive vaccination in the opposite arm and that she should wait around for 30 minutes for observation instead of 15 minutes. Patient received vaccination at approximately 10:25am. At 5:30pm, patient called back to the pharmacy saying that she had a swollen and bruised arm around the injection site area and underneath the inject-safe bandage. Patient came to the pharmacy at 5:45 pm with the bandage removed where the pharmacist was able to see the arm and both patient and pharmacist agreed that the swollen area appeared as though it was going down. Patient was advised to use a cool compress for the swelling and bruising and that we would follow up with each other on Monday.
Left arm was swollen, red, and stinging, with a red stripe down her arm (reported by patient). At visit on 10/18/16: left upper arm is tender to palpation, near axilla. Resolving barely noticeable erythema from mid biceps to proximal forearm. Circumference is 39 cm and equal to right arm.
red welp, that itches, warm to touch,  increasing in size as the morning continues.  approximately 6 x 8 mm
PM 6 hours after the shot. Shaking chills. Burning feeling in hands turned into complete numbness in fingers and toes. That lasted 3-4 hrs. Next day sweats on and off I broke out in bumps on my face and scalp. Did not feels normal for about 10 days.
Fever 101.8 within 9 hours of vaccine; chills; fatigue; nausea; dry heaving; diarrhea; arm pain; loss of appetite; This is a spontaneous report from a non-contactable other hcp (health care professional). A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 17:15 pm (Batch/Lot Number: EN5318) as dose number unknown, single for covid-19 immunization (at the age of 30-years-old). Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included spironolactone (100 mg) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to augmentin and azithromycin. It was reported that after receiving the dose of vaccine 03Feb2021 at 17:15 pm and on 04Feb2021 at 02:00 am the patient experienced fever 101.8 within 9 hours of vaccination and also experienced chills, fatigue, nausea, dry heaving, diarrhea, arm pain-all lasting 48-72 hours. 6 days later-still have nausea, loss of appetite, diarrhea, fatigue. Therapeutic measures were taken with Tylenol as a result of adverse events. The patient underwent lab tests and procedures which included body temperature: 101.8 on 03Feb2021 and sars-cov-2 test (nasal swab): negative on 10Feb2021. The outcome of the event fever was reported as recovered with Sequel on an unspecified date in 2021 and patient was recovering from the events of chills, dry heaves and pain in arm and was not recovered from the events of fatigue, nausea, diarrhea and appetite lost.
Severe pain in the Left shoulder consisting of dull pain, throbbing, stabbing pain, sharp pain, burning; weakness, difficulty moving. At this time 2 week duration. Affects sleep and ability to fully use arm.
Fever; Chills; Body aches; Headache; Neck pain; Weakness; Loss of appetite; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Aug2021 at 17:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Jul2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 11Aug2021, the patient underwent COVID-19 test and the result was negative. On 13Aug2021 at 06:00, the patient experienced fever, chills, body aches, headache, neck pain, weakness and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, headache, neck pain, weakness and loss of appetite was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed 1cm X 2cm area of erythema overlying 2cm X 3cm area of induration on anterio-lateral aspect of right thigh at site of Hep/Hib vaccine injection.
Information has been received from a licensed practical nurse concerning a 4 year old male patient with no allergies and no pertinent medical history who on 8/3/99 was vaccinated with a dose of varicella virus vaccine live. According to the mother, on approximately 9/20/03, the patient developed a fever for a couple of days and then broke out in spots. On 9/27/03, the patient presented to the medical office with approximately 15 lesions. The reporter stated this was a mild case of chicken pox breakthrough. The patient was treated with diphenhydramine hydrochloride and calamine (+) camphor (+) pramoxine hydrochloride. A product quality complaint was not involved. Additional information is not expected.
8/5/19 Pneumovax. 8/6/19 rash to buttocks 8/28/19 rash worse on buttocks- reached out to Dr by text and Keesler cream started. 9/5/19 appointment for diaper rash continued Keesler cream. 9/16/19 appointment for diaper rash and treated for folliculitis. 9/20/19 saw dermatologist and culture of lesions was inconclusive. 11/20/19 rash now on anterior thighs. 2/2020 saw pulmonologist who noted rash in his notes 5/14/20 Saw ENT who documented rash and felt too inflammed to be keratosis pilaris. 6/16/2020 saw Dermatology who stated diagnosis of keratosis pilaris verses folliculitis 7/22/20 saw MD with documented rash unclear etiology on arms and legs. 8/24/20 Dermatologist again says keratosis pilaris verses folliculitis. Rash is  papular and  angry red homogenous on dorsal surface of thighs and upper arms
Narrative: 78yo male home hospice pt with Hospice Diagnosis:Chronic Systolic (Congestive) Heart Failure died at home on 8/21/2021. Pt had received covid vaccines on 1/29/2021 & 3/1/2021. Death is not related to vaccines
She did not need a DR appt. but had a large round red circle that was warm to touch and about the size of a small pancake. She did not present with a fever or headache. She did take Tylenol and used ice. We explained this may possibly be a common localized reaction when getting any vaccine.
Headaches  Body aches  Low-grade fevers  involuntary body movements  Confusions
A 13month old was inadvertently given a higher than recommended dose of 3mcg  for 6month to < 5years. The nurse did not dilute the vial at all and drew up 0.2mL of vaccine and administered it to patient. We realized the mistake within the 15min that the patient was here waiting. We reached out to VAERS, Pfizer Medical information, and ED on what we needed to next for patient. Dr. went into and told the mom that she received a higher than recommended dose. She discussed possible side effects and signs and symptoms to look out for. Gave her her personal number and advised to go directly to ED or call 911 if any symptoms develop.
fever, stomach upset, lightheaded & pain in lt axilla; pt is 5"11" & weighs 160lbs;
Headache  Acute onset of a throbbing frontal headache and sensation of lightheadedness  Narrative:  37 yo MALE with pmh of migraines for which he intermittently takes  sumatriptan presenting with possible covid vaccine reaction. Patient received his second COVID-19 vaccination approximately 30 minutes ago. Patient does report relatively acute onset of a throbbing frontal headache and a sensation of  lightheadedness. He denies any changes in vision or speech. No numbness, weakness or tingling of extremities. No rash, fevers, nausea or vomiting. No history of prior vaccine reactions. Patient states does not feel like a typical migraine. Given tylenol and ibuprofen, and discharged from ED.
pt recv vax 24OCT95 & w/in 12-24 hrs devel in inj site rxn characterized as red, hard, & warm;f/u info was recv on 7MAR96;sx lasted 2-3 days & resolved
Few hours after vaccine, developed chills, body aches, fever, dizziness and light headedness x 5 days. Day 6 (10/5/16) - woke up with slight left droop - went to ED.
Right upper arm where vaccination was placed is warm to touch and slightly swollen. Temperature was taken - 98.2F. Reported to RN Manager. Doctor was called to assess, and she advised patient to put ice and to observe for fever and other worsening symptoms. Also made a follow-up appointment with patient's primary care provider on Aug 3, 2006 @ 10:45AM. Patient is aware of his appointment.
yesterday pfizer covid-19 vaccine. Lot 32030BD. he and wife got vaccine from the same lot. last night developed severe myalgia, chest pain - intermittent stabbing left chest reproducible worse with lying flat especially with the shortness of breath, cough is productive - phlegm - clear,  some shortness of breath  no leg swelling  arm where got the vaccine minimally red  not taking meds for the cough
This spontaneous report as received from a pharmacist via a company representative refers to a 70 year old female patient. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history and concomitant medication. On an unknown date in approximately 2013 (reporter as "5 years ago"), the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed a chronic condition. It was unknown if the chronic condition occurred before or after administration of PNEUMOVAX 23. Furthermore, was unknown by the reporter if any treatment was given for the adverse event or if any laboratories diagnostics or studies were performed. The outcome of chronic disease was reported as not recovered. The causal relationship between chronic disease and PNEUMOVAX 23 was not reported.
posterior vitreous detachment of both eyes; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 18-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered blurry vision and was diagnosed with posterior vitreous detachment of both eyes (vitreous detachment). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for the event was not recovered. The reported considered the vitreous detachment was related to zoster vaccine live (ZOSTAVAX).  It was considered that the vitreous detachment was a disabling event.  Upon internal review, the vitreous detachment was a medically significant event.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # M000442 with expiry date 31-MAR-2018 (exact dose and route of administration were not reported). The doses were exposed to the temperature of 46.8 degrees Fahrenheit for 13 hours. Previous temperature excursions included 48.2 degrees Fahrenheit for 13 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter.  Additional information has been requested.
Ear ache and pressure behind eardrum, tenderness in ear canal, minor sinus congestion
Pt described cough and wheezing, mild throat swelling and itchiness s/p injection lasting several hours. Did not seek medical care. Resolved within 8 hrs. No h/o prev Flu vax. h/o Td 2005. NKDA, no h/o of vax Rxns.
RIGHT ARM WEAKNESS AND EPISTAXIS. EPISTAXIS RESOLVED AFTER 2-3 MINUTES. RIGHT UPPER EXTREMITY EXAM WNL. VITAL SIGNS WNL. REPEAT HGB WNL.
I woke up the morning after the shot, and my right shoulder and arm were very sore. As the days proceeded, the arm & shoulder became very painful. Couldn't raise my arm and can't reach for anything without great pain. 18 days has gone by and still very painful.
Pt recvd vax 17NOV92 & 2 hrs p/vax pt stated entire arm hurt & devel a severe h/a; had msucle spasms & contractions all noc; next day had difficulty breathing & stated that heart was beating very hard; also had nausea & insomnia;
On 09/21/17, pt received an influenza virus vaccine injection in an undesignated arm. Immediately after the injection, pt reported pruritus that extended from injection site to the elbow area. Pt then developed a 3 x 3 red firm area that was warm to the touch. No report of interventions. No documentation of lot number. RN self-reported event. No further information available.
This spontaneous report was received from a mother referring to her daughter, 21 year old female patient. The patient had no concomitant medications and pertinent medical history. The patient was allergic to amoxicillin. In June 2018, the patient was vaccinated with GARDASIL 9 one injection (lot #, expiration date, dose, strength and route of administration were not provided) for HPV prevention. On an unknown date in June or July of 2018 (reported as one day following administration), the patient experienced night sweats, dizziness, lethargy, fatigue and nausea for one month after getting the first dose of GARDASIL 9 vaccination. The patient sought medical attention by speaking with physician. The patient had no laboratory tests performed and no treatment was administered for the events. The outcome of night sweats, nausea, fatigue, lethargy and dizziness was reported as recovered in approximately July 2018. The causal relationship between the events and therapy with GARDASIL 9 was not provided by the reporter.
Moderate pain at the injection site. Mild Nausea, Moderate Fatigue.