chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 20 year old female with no pertinent medical history or drug allergies or drug reactions, who on 16-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no. 660391/0063X). On 16-MAY-2008 the patient experienced white circle at the injection site that eventually went away. There was no concomitant therapy. On 17-JUL-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) and the white circle at the injection site reappeared and it was still there. The patient sought unspecified medical attention. Additional information has been requested.
Individual received wrong dosage of vaccine.  Diluent used for reconstitution was not full amount.
some of the vaccine run out down arm; some of the vaccine run out down arm; the vaccine to run out and down the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number D4CZ3, expiry date 10th April 2023) for prophylaxis.   On 14th January 2022, the patient received the 1st dose of Shingrix. On 14th January 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were reported as follows: The pharmacist reported that during administration of first dose of Shingrix series to the patient by a student, the seal between the needle and syringe leaked, causing some of the vaccine to run out and down the patient's arm, which led to accidental underdose, exposure via skin contact and accidental exposure to vaccine. The amount of product patient actually received was unknown. Till the time of reporting, the patient was not re-dosed. Consent to follow up was granted.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that the patient received a dose of (Oka/Merck) PROQUAD (dose and route of administration unknown) and a dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneous) during the same visit on 30-JUL-2014. Pertinent medical history and concomitant medications were unspecified. No symptoms reported. The outcome of event was unknown. No further details was provided. Additional information has been requested.
Sept 7, began having increasing head, chest, & extremity pain which strongly increased if lying down.  3 episodes over the next month required ER visits because the chest pain was radiating strongly into arms. Also had periodic pain behind knees, groin, and abdomen.  EKGs, stress test,  CT for head, legs, and cardioangiogram were eventually given and returned normal.  Over time symptoms are declining significantly, although they have not completely resolved as of today, 11/19.
Fainted; Mom thought maybe dehydration; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Leg Right on 06Jun2021 10:30 (at the age of 16 years old, not pregnant) (Lot Number: Ew0191) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: Ew0185) in Right arm on 16May2021 10:30 (at the age of 15 years old) for Covid-19 immunization and no events reported. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. On 08Jun2021 at 18:30, the patient fainted in kitchen at night on day 3 after second dose, over 48 hrs after shot. Mom and dad caught her and put her on floor until she came back. Mom thought maybe dehydration so gave pedialyte but didn't know if that was reason. She slowly felt better. No treatment for fainted. The reporter considered the report as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Numbness of left foot, skin on toes, instep, medial aspect of foot and arch, extending up shin about half way. Also rapid burning sensation of skin, itching, (severe) on skin on chest and back.
About 2 weeks later, I started to feel "off" . Just not right. Brain Fog along with Short term memory impairment; About 2 weeks later, I started to feel "off" . Just not right. Brain Fog along with Short term memory impairment; Blurry vision; Difficulty Driving; light Headed; Ringing in the Right Ear; Shortness of Breath; No attention Span; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 07Jun2021 at 11:00 (at the age of 54-year-old) as dose 1, single for COVID-19 immunization at Public Health Clinic/Veterans Administration facility. Patient had no medical history. Concomitant medication in two weeks included levothyroxine sodium and hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient took first dose of Pfizer on 07Jun2021 at 11:00 am. She did not notice any immediate side effects. About 2 weeks later on 21Jun2021, she started to feel off. Just not right. Brain Fog along with Short term memory impairment. She did not think too much off it then, but the symptoms became gradually worse. Other symptoms started to appear blurry Vision, difficulty driving, light headed, no attention span, ringing in the right ear and shortness of breath. Patient reported that the symptoms did not seem to be going away. She had an appointment with her PCP next day at the time of reporting. No treatment received for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Pain, fatigue. "Aerobic capacity has severely diminished" "chronic state of ill healthy".
Patient came into clinic 3 days after recieving the injection. Right arm was swollen and red, tender and itchy. The Erythema spread 2-3 inches from the injection site. Injection site was warm and tender to the touch. Patient had a hard lump at the injection site. Advised on warm compress and tylenol.
Patient developed right sided unilateral swelling of tongue on the morning of 9/17/21. Presented to the emergency department. Received IV steroids, benadryl, and pepcid with improvement of symptoms. Discharged on 9/18/21 with diagnosis of angioedema (secondary to flu vaccination on 9/15 or long standing losartan prescription). Prescribed prednisone 5mg PO for 4 days. Discontinued patient's losartan prescription, as well.
allergic reaction; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of allergic reaction in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-FEB-2023, the patient received the 1st dose of Shingrix. On 30-MAR-2023, 32 days after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date: 23-Oct-2023 The patient received a dose of Shingrix and reported that had allergic reaction. No additional information was provided. The reporter consented to follow-up.
administered the liquid component of the Pentacel to a patient without diluting the lyophilized component (with no reported adverse event); Initial information received 19-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 weeks old male patient who experienced administered the liquid component of the pentacel to a patient without diluting the lyophilized component (with no reported adverse event) while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for prophylactic vaccination, pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for prophylactic vaccination and rotavirus vaccine for Prophylactic vaccination.  On 06-May-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (strength, formulation: unknown) (lot UJ531AAA; expiry date: 22-Jul-202) via intramuscular route in right thigh for prophylactic vaccination.  On 06-May-2022 (latency: same day) the patient experienced administered the liquid component of the pentacel to a patient without diluting the lyophilized component (with no reported adverse event) (product preparation error) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken; not applicable.  At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red and itchy face; Red and itchy face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jun2021 15:15 (Lot number: EW0186) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Epinephrine (may be), reaction(s): "Known allergies: Epinephrine (may be)", notes: Known allergies: Epinephrine (may be). The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 23Jun2021, outcome "unknown" and all described as "Red and itchy face".  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
On 7/28/03 pt seen for check up found normal 5 mos development doing fine at home except on Sunday 7/27/03 one night prior, one episode of arm extension and eye staring, parent did not notify physician. Baby shots were given on 7/28/03 (DTaP, IPV, Hib Titer and Prevnar). Following day of 7/30/03 several episodes of body stiffness and eye staring, without fever. Parent brought to clinic and sent to ER. Lab and CT scan normal, pt transferred to hospital. MRI of skull normal EEG abnormal. Neuro impression partial-seizure disorder or r/o early infantile spasm. No tonic or clinic spells reported or noted. Pt treated with phenobarbital and discharged from hospital Sat. 8/2/03. Information from Discharge summary, medical records states irritability, eyes rolled up, seizure disorder. msv
Raised , hard red lump on upper arm appearing 1 week after shot.  Itchy
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/13/21 (EM9809) Pfizer Dose 2 4/3/21 (ER8729) COVID Positive 12/2/21  12/2/21: 71-year-old female with past medical history of COPD, CAD with quadruple bypass in 2005, hypertension, hyperlipidemia, chronic venous stasis presents after experiencing worsening shortness of breath.  Patient described starting to have shortness of breath states about a week ago after she inhaled some burning leaves. Progressively worsened and today she felt like she could not get any air in.  Patient is not oxygen dependent at baseline.  Patient is a former smoker.  Patient is vaccinated for COVID.  Patient tested for COVID in the ED and is positive.  12/4/21: 2019 novel coronavirus detected. Bilateral pneumonia. COPD exacerbation. Make note of changes to medications. Start taking Levaquin on 12/6/21. Use home oxygen as directed. Quarantine 10 days from positive COVID test.
Swelling in axilla, left arm, left side of chest and face, left thigh.  Burning sensation / irriation of skin.  Tightness in chest.  Rash (diffuse macular), headache, dyspnea (mild), irritability and fatigue.
Within five minutes after receiving FLUVIRIN patient had tingling in left arm (site of shot). Patient did not report till morning of 9/24/11. Morning of 9/24 patient also noticed tingling on (L) back side and still in left arm.
Injection site soreness began within 15 minutes and worsened through the day and night. Sore to lift arm Headache and back ache began about 2 hours after the injection  Fatigue  Entire body aches and headache upon waking the next day Used Tylenol and Ibuprofen to lessen the pain
tested positive for coronavirus; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program COVAX support. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, the patient tested positive for coronavirus. The patient underwent lab test which included SARS-CoV-2 test: Positive on 14Apr2021. The second dose of the vaccine was scheduled on 05May2021 and patient was asking if this was okay. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pain in the arm; anxious; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced pain in the arm, anxious. It was reported that a local Pharmacist recommended to take 220 mg of Aleve, an NSAID, for any pain in the arm. She was asking if it was okay that she took Aleve since they usually recommend Tylenol for Moderna COVID shots. They noted that she was fine and only took the medicine because she was anxious and wanted to take it just in case. They were asking if this could weaken the shot or the vaccine. Reporter stated, She just had a question she got Pfizer vaccine (Unspecified vaccine) the first dose today and she is doing fine. Reported that one of her friend recommended that she take an Aleve to help with any arm pain or anything like that and then the local pharmacist said that they don't recommend to take Aleve, just take Tylenol. If she took an Aleve is that a problem or not. The outcome of events was unknown.  Information about lot/batch number has been requested.
swollen lymph nodes on the left side, including above her clavicle; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and LYMPHADENOPATHY (swollen lymph nodes on the left side, including above her clavicle) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on the left side, including above her clavicle). At the time of the report, PAIN IN EXTREMITY (Sore arm) and LYMPHADENOPATHY (swollen lymph nodes on the left side, including above her clavicle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
I developed a rash approximately 3" long and 2" wide at the injection site. This did not concern me. However, the next morning I realized my armpit was sore (on the same side as the injection). When I looked at my armpit it appeared as though there was a pool of fluid under the skin of my armpit about 4" long and 2" wide. The skin on this area also had a rash. Before I called our doctor, I checked on line and learned that about 1% of people who received COVID vaccine (not sure if was Pfizer)  had this same reaction. Since the website suggested the fluid build-up and rash in that area were part of the body's reaction to the vaccine, I decided not to call the doctor. These reactions took about 5 days to completely resolve, but they did resolve.
Bradycardia, Left Atrial Enlargement on EKG, Chest Pain
Nasal Swab: positive; covid test date=04/Jan/2022; Nasal Swab: positive; covid test date=04Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 (Lot number: EW0185) at the age of 41 years as dose 2, single and administered in arm left, administration date 29Apr2021 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothryoid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient did not received any other Vaccine in four weeks. Patient did not have covid prior vaccination and post vaccination the patient tested for covid. Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Jan2022, outcome "unknown", described as "Nasal Swab: positive; covid test date=04/Jan/2022"; COVID-19 (medically significant) with onset 04Jan2022, outcome "unknown", described as "Nasal Swab: positive; covid test date=04Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.  Follow-up attempts are completed. No further information is expected.
10 mins after receiving Hep B vaccine #2, left deltoid swollen, red, warm to touch. Dr was notified when Benadryl 25mg every 4 hrs for couple of days if tolerated if not Claritin 10mg OTC. Apply ice to L arm. No systemic sx noted at this time. Swelling decreased after taking dose of Claritin.
Prevnar 15 given- total of 5 doses   pt is an 18 month old who received Prevnar 13 on 1/27/23 (Pneueme 15), 10/18/2022 (Prevnar 13), 1/7/2022 (Prevnar 13), 11/12/2022 Prevnar 13, 9/9/2021 Prevnar 13
pt recv vax 28AUG95 & 14MAR97 pt devel varicella-like rash w/hundreds of spots;it was noted that pt was not febrile & returned to school in 1wk;
Rash raised rounded erythematous papules of various sizes. Some exonated areas of face, hair line no fever.
approx 2 hrs p/receiving immun started to cry high pitched screaming lasting 4 hrs inconsolable; gave APAP mom called family MD did not visit MD office;
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 32 year old male of unspecified race and ethnicity. Initial information was processed along with additional information on 21-JUL-2022 The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered at right arm on 09-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 31 years old. The batch number was not reported and has been requested. No concomitant medications were reported. The patient additionally received non-company suspect vaccine elasomeran (moderna) (dose number in series 2) (form of admin and route of admin not reported, batch number: unknown expiry date : unknown) dose was not reported, administered at right arm on 05-NOV-2021 for covid-19 prophylaxis.   On an unspecified date in JUN-2022 patient had COVID-19 (confirmed covid-19 infection) (dose number in series 2). The patient received non-company suspect drug paxlovid (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered from 29-JUN-2022 to 04-JUL-2022 for covid-19 treatment. On 11-JUL-2022, the patient experienced rebound COVID symptoms (dose number in series 2). On 12-JUL-2022 patient tested positive with antigen test eight days after finishing paxlovid regiment which resulted to confirmed vaccination failure (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000243191.; Sender's Comments: V0-20220737632-COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Breakthrough  case admission after 2 vaccines Moderna 8/26/21 lot# 052E;  Moderna 9/25/21 lot# 066D
This spontaneous report as received from a 65 year old male consumer reporting on himself. Approximately in February 2014 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported). Concomitant therapies included amlodipine strength: 10mg, omeprazole (manufacturer unknown) strength 40 mg and oxycodone. Approximately on 03-FEB-2016 (reported as approximately 7 days ago), the patient experienced "shingle like symptoms but no rash" and pain "2 inches into to the left of his belly button" (also reported as adverse event experienced while using ZOSTAVAX). The patient sought medical attention. On an unknown date, unspecified blood work and urinalysis was performed (results not provided). At the time of the report, the outcome of herpes zoster and abdominal pain was unknown. Relatedness between the therapy with ZOSTAVAX and the events was not reported. Additional information has been requested.