chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Glaucoma as a result of detachted retina, several years ago; "spinal fusion" (unspecified if ongoing), notes: Recent spinal fusion; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Glaucoma as a result of detachted retina" (unspecified if ongoing), notes: Glaucoma as a result of detachted retina, several years ago.; "Mold" (unspecified if ongoing); "allergy to certain eye drops" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flomax, notes: Use flomax. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (09Sep2022) Positive, notes: Restested on 09Sep with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if the patient took other medication in last 2 weeks. Patient took Paxlovid as a treatment from Sep2022 to Sep2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a back office lead and refers to a currently 36 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L004658, expiration date: 11-FEB-2017, 0.5 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 2 year old male who on approximately 25-SEP-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). It was reported that on 22-SEP-2007 he developed a rash on his left upper chest, neck, and upper back and was diagnosed with herpes zoster. On 25-SEP-2007, a five day course of therapy with acyclovir, 1.5 teaspoons four times a day was instituted. No fever was reported. It was reported that on 29-OCT-2007, a specimen for varicella zoster virus identification was obtained (results not reported). Current patient status was not reported. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
A report has been received from a Health Professional concerning a 15 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 24-Sep-2014. The patient experienced tested positive for flu which started on 24-Nov-2014, fever and sore throat. The outcome of the event of fever and sore throat is unknown and at the time of reporting, the event of tested positive for flu was ongoing. The report was considered to be non-serious.
elevated temp 2 hrs p/vax; sz 6 hrs p/vax; eyes roll back 6 hrs p/vax; hospitalized till 2300 11JAN94
Location: left mid/upper chest. Status: no change. Denies aggravating factors. Denies relieving factors. Associated symptoms include upper ant. shoulder felt warm. Denies: numbness, tingling, pain with arm movement, tenderness, GI and resp sx.Pt reports that she had chest pain on Sunday that lasted less than a minute. Describes pain as being very sharp and she felt a warm sensation in L shoulder. Pt denies SOB. Pt feels fine today just wants to get this checked out and make sure everything is okay. Got covid vaccine (2nd shot) on 4/10. After the eps it felt like heart was racing a bit, not irregular, lasted < 1 min. Denies GI, Resp sx associated. Occurred in the middle of church, not exerting herself. Occurred once a few days before, very brief and not as strong. No hx of cardiac issues. No assoc. breast sx, axillary swelling.  Referred to cardiology for abnormal EKG
Stayed for 15 minutes after the vaccine given and no reaction was noted and she left.  States she got into her car about 20 minutes after the vaccine and started to "itch" all over and noted "red bumps" on the back of her neck.  She had a flushed face by the time she arrived home but remained afebrile.  Her itchiness is better but only concentrated on the back of her neck on 12/17/20 when she reported the reaction to Employee Health Services.  She denied any further issues today.
Had a sore arm.; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021298895.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (Batch/Lot number: unknown, Expiration Date: 30Jun2021) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had a sore arm."; PAIN (non-serious), outcome "unknown", described as "soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pain.  Additional information: She stated that she got the first dose and got no problems or side effects, just took an Ibuprofen for the soreness. and sore arm. She also mentioned that she went to get a MRI because she was having shoulder soreness in between of the 2 doses of the covid vaccine and no one told her that she should not because of the vaccine. She was in this study to discover if her soreness was frozen shoulder, but it was not. She stated does having a lab work have anything to do with it because she has a 'frozen shoulder test' to see if she qualified for it because she was a writer, and her shoulder was bothering her and got to do the test to see what it was.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe anxiety and panic attacks not able to be controlled with medication wondering if its taking the same pathway as my medication because this exact thing happens if I use terbinafine in any form. Its like my prozac got turned off. I'm not sure if I should take more or back off.
urticaria react to Hep B per MD; rash on legs & back mostly on leg inject was given in; given PDH for itching; 10FEB94 rash on face only;
Sore arm lasting for three days. Lymph Node swelling left axillary region.
pt inadvertantly recvd DTP instead of Td; 24 hrs later had fever, swollen arm, knot @ inject site & achy all over;
4-23-21 Discomfort at injection site, otherwise feeling very good.   4-25-21  At approx. 10 PM experienced rapid onset of acute nausea and mild vertigo.    4-26-21 After a sound night's sleep by 7 AM, the above (4-25) symptoms diminished.  However, by        10 AM nausea symptoms became acute AND vertigo symptoms markedly increased, making the room look like it was spinning. Patient was able to bed rest until 1 pm and felt much better with symptoms markedly diminishing to low level 'dull nausea'.   4-27-21 After sound sleep, all above symptoms tapered off, leaving patient with very low energy level, yet able to perform ADLs--and feeling more homeostasis by 8 PM.
flu symptoms; arm pain; BP elevated; pulse increased; not sleep; Very sick; This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness. On an unknown date, the outcome of the flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness were unknown.   It was unknown if the reporter considered the flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness to be related to Shingrix.  Additional details were provided as follows: The patient experienced flu symptoms, pain in arm, increased blood pressure, pulse increased and was not able to sleep. The patient's blood pressure was elevated 144/88 mmhg and pulse rate was 101 per min. The patient was very sick.
patient was given an expired MENACTRA injection with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient and it was reported patient was given an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] injection with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-JUN-2023, patient was given 0.5 mL of expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] Solution for injection (batch/lot number: U6824AA; expiry date: 01-jun-2023; strength: standard; frequency: once; 1X) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (latency: same day).  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.
AFTER THE INJECTION REPORTED BEING LIGHT HEADED/DIZZINESS FOR 15 MINUTES. THAT EVENING INTERMITTITENT CHEST PAIN FOR 4 DAYS.
I developed severe tinnitus after receiving the second Moderna vaccine and it has not subsided. It's interfering with my daily life and has adversely affected the quality of my life. Today I'm going to see an ENT doctor for evaluation. Now I see and hear that many people are experiencing the same loud ringing tinnitus after receiving the Moderna vaccine.  I can only make the correlation that the loud ringing that goes on 24/7 began after getting the vaccinations.
extreme rash, itching covering 7 x 3" area on upper left arm since 2/21.
This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to a 68 years old male patient with asthma, diabetes, hypertension and hyperlipidemia. The patient's medical history included anemia. The patient had none drug allergies. On 17-SEP-2012 the patient was vaccinated with a single dose of ZOSTAVAX (lot # 673029/0616AE, expiration date 28-JUN-2013) subcutaneously. Concomitant medications included multiple unspecified medications. On 18-SEP-2012 the patient developed lesions on one side of his chest and back. The patient sought for medical attention by coming to the office on 18-SEP-2012 and was diagnosed with shingles. Lab diagnostics studies performed were reported as none. The outcome of shingles was reported as not recovered. Additional information has been requested.
Resident tested positive for Covid 19  with symptoms of nasal congestion , headache , and poor appetite
VACCINE WAS  GIVEN TO A 16 YEAR OLD MALE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced vaccine was given to a 16 year old male. On 12-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was given to a 16 year old male was not reported. This report was non-serious.
Diffuse urticaric rash over torso, starting on abdomen and spreading to back, breasts, neck, and thighs.  Rash is mildly itchy that worsens with heat.  Unimproved with OTC Benadryl or Zyrtec.  No other known cause of rash, including changes in detergents/soaps, foods, or other exposures.
bell's palsy; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In 2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions.  On an unknown date, the patient experienced bell's palsy. The outcome of the event was unknown. As per the reporter, the patient has suffered and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The event of bell's palsy was determined to be disabling and medically significant. The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
red rash to inner thigh regions, back, close to both armpits, mostly in areas where sweat a lot, rash is red and slightly bumpy, no pain or itch
Right shoulder tightness, pinching sensation when lifting arm above head and rotating backwards and limited range of motion.  Unresponsive to application of cold and heat, elevation of affected limb, topical over the counter medications, and acetaminophen and ibuprofen.
Vomiting, constant headache, vision changes, seizures, numbness/tingling in hands and feet, brain fog
Vaccinator mistaken they were providing Moderna booster doses but she was administering primary series Moderna.  Pt was incorrectly given 2 full doses of Moderna for dose 2.  No ADRs reports to writer at time of this report.
Had flu shot, throat started to tickle, started coughing-felt throat thickening, had shortness of breath, difficulty breathing, called 911 and gave EPI. Transported to hospital. Husband present- Observed her for several hours gave a breathing treatment and sent her home.
Rash appeared on trunk; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared on trunk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced RASH (Rash appeared on trunk). At the time of the report, RASH (Rash appeared on trunk) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Cholesterol high.    On 09-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a monovalent doses instead of a bivalent dose).    Patient had no allergies.  No concomitant medications were reported. No treatment medications were reported.
Case number PHEH2015US021674, is an initial spontaneous report from a health care professional received on 22 Oct 2015. This report refers to a 13-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX (batch number: 173989) intramuscularly on 22 Oct 2015. No adverse event was reported.
patient received expired Menactra, no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA244698 (same reporter).  This case involves a 15 years old male patient who received an expired 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5835AA, Exp. Date 27-Feb-2019) via intramuscular route in the right arm, on 25-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was reported that there were three different patients total who received expired doses of vaccines. Two patients received expired Menactra and one patient received expired ActHIB.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.   Documents held by the sender: none.
Pain at the injection site for one week, had to takes aleve twice a day.  For 24 hrs had chills, body aches, sore joints, and nausea.
pt recv vax & 1wk post vax pt exp itching & dry, scaly skin @ the inj site;sx resolved p/ 1 1/2 wk w/o tx;
Woke up with stabbing central anterior chest pain.  worse with sitting up better with laying down.  Similar to patient's prior episodes of pericarditis.  Patient called triage nurse advised ED evaluation for chest pain.  has not taken any medication for pain. Patient Reevaluation: Likely pericardidtis by hx.  EKG normal. Check trop to r/o myocarditis.  Pt written for one dose of IM toradol.
Arm hot red & swollen (right arm) child crying c/o pain 8/12/12 - saw Dr. 8/13/12.
they had the flu for a couple of days after which they felt fine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they had the flu for a couple of days after which they felt fine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (they had the flu for a couple of days after which they felt fine). At the time of the report, INFLUENZA LIKE ILLNESS (they had the flu for a couple of days after which they felt fine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
1) On 8/29/08 described the following TWINRIX #2 had 2 "episodes" of lack of upper body strength (from collarbone to nipple line) lasting several minutes saw his physician. 2) Phoned office 9/25/08. Had two more "episodes" following TWINRIX #3 on 9/25/08. First episode on 9/13 lasting 2-3 min, 9/16 lasting 5 min. States as if "somebody pulled a switch".
Pulled a muscle when out in the yard doing work; Hurts when he walks; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (Pulled a muscle when out in the yard doing work) and MYALGIA (Hurts when he walks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE STRAIN (Pulled a muscle when out in the yard doing work) and MYALGIA (Hurts when he walks). At the time of the report, MUSCLE STRAIN (Pulled a muscle when out in the yard doing work) and MYALGIA (Hurts when he walks) outcome was unknown.            No concomitant product use was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR received on 28-APR-2021 and does not any new information
Information has been received from a physician concerning a 12 month old female twin who on 6/13/03, two weeks ago, was exposed to her mother who had herpes zoster. On 6/17/03 the patient was vaccinated IM with a dose of varicella virus vaccine live. On 6/26/03 the patient started to developed generalized vesicles all over her body with at least 50 lesions. The physician was going to speak to the parents to see if they wished to pursue a lab culture of the vesicle. No additional information was available. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. It was also reported that the patient's twin sister was vaccinated with a dose of varicella vaccine live and developed the same reaction. Additional information has been requested.
Had DTAP-IPV yesterday. Starting during the night, vomiting and temperature 101 degrees. Vomited x1 this AM, placed on BRAT diet.