chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of dizziness in a female patient who received BEXSERO. On 10th January 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 10th January 2018, less than a day after receiving BEXSERO, the patient experienced dizziness, confusion, tremor, nausea, facial swelling, red face and facial pain. On 11th January 2018, the patient experienced swallowing difficult and hives. In January 2018, the outcome of the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain and swallowing difficult were recovered/resolved. On an unknown date, the outcome of the hives was unknown. The reporter considered the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain, swallowing difficult and hives to be probably related to BEXSERO. Additional details were provided as follows: Medical Science liaison reported on behalf of health care professional. The patient was administered BEXSERO in the morning. Later in day, patient experienced dizziness, confusion, shakiness and nausea, followed by red swollen and painful cheeks. On 11th January 2018 in the morning, one day after receiving vaccination, the patient experienced hives on chest, shoulder and legs appeared along with difficulty swallowing (no respiratory distress). The patient reached out to facility in afternoon. The patient told to be seen immediately. When the patient was seen at 5pm on only remaining event was hives. The Medical Assistant (not reporter) noted hives as itchy and painful on right hand which spread to left shoulder and left side of chest; no mention of hive on legs.
Apx 10 minutes after vaccine administration, Patient became non-responsive, his eyes rolled back in his head, and appeared tonic. His mother said this has never happened to him before. When he recovered he was disorientated and complained of blurred vision. He later said he thought he fell asleep. It is unknown if this is related to the vaccine. We took his pulse (apx 50 bpm) and gave him water. We called 911 and the paramedics evaluated him in the ambulance.
Patient started to experience pain in right arm on morning of 10/21/20.  The pain is radiating to the right hand side of her back.  Patient will follow  up with her doctor if she does not improve.
Severe pain in the knee and ankle, tremor throughout the body that made it impossible for him to walk, inflammation of all joints. Presented high blood pressure for the next 3 months.
Started with headache the night after vaccination and then 12 hours after vaccination, woke up with chills, nausea, and extreme dizziness. I was unable to walk around my house without having to lie down to avoid fainting. These continued overnight. Next day, on/off fevers, headaches, fatigue, and dizziness continued. Symptoms were gone by 3/31/21.
This spontaneous report as received from a pharmacist via field representative refers to 3 anonymous patients (demographics unknown). On an un unknown date in 2013, a few months ago, the 3 anonymous patients was vaccinated with ZOSTAVAX vial single dose of unknown lot and expiry date via unknown route in the arm for prevention of herpes zoster. All the patients had developed swelling under the arm below injection site after receiving the ZOSTAVAX. The outcome of swelling under the arms below injections site was reported as resolving. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 5 year old female patient with no pre-existing medical conditions who on 8/13/99 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 630409/0297J). Concomitant vaccine therapy administered on the same day included a SC first dose of MMR (lot # 631645/0921J). The patient was not ill at the time of vaccination. On 5/22/04, the patient developed varicella. The licensed practical nurse reported that the patient recovered. No laboratory or diagnostic test was performed. Additional information has been requested.
left supraclavicular (above the collar bone) lymph node is swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (left supraclavicular (above the collar bone) lymph node is swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 930676 and 067F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (left supraclavicular (above the collar bone) lymph node is swollen). At the time of the report, LYMPHADENOPATHY (left supraclavicular (above the collar bone) lymph node is swollen) had not resolved.            Concomitant medications include Synthroid for unknown indication  Company Comment : This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of supraclavicular lymphadenopathy. The event supraclavicular lymphadenopathy occurred 1 day after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of supraclavicular lymphadenopathy. The event supraclavicular lymphadenopathy occurred 1 day after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
2/4/21-chills, fever, abdominal pain, body aches, sore arm; 2/8/21-asthma flare up, chest pain and tightness, rash on legs, bruised injection site.
The morning after receiving immunizations, pt awoke with erythematous, raised area at site on right thigh, also with hives on trunks, arms, legs.  ER visit then seen in our office on same day.  We saw 3x3 inch indurated, erythematous area on right thigh with erythematous, urticarial lesions on trunk, face, lower back, some on arms and neck.  Did well on Benadryl. Resolved by 2 days later.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 86-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 10th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th August 2018, several hours after receiving SHINGRIX, the patient experienced fatigue, muscle weakness, nausea and muscle pain. On an unknown date, the outcome of the fatigue, muscle weakness, nausea and muscle pain were recovered/resolved. It was unknown if the reporter considered the fatigue, muscle weakness, nausea and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist called on behalf of a patient. Few hours after receiving SHINGRIX, the patient experienced fatigue, nausea, muscle aches and muscle weakness.
Pt vaccinated with DTP/OPV dev local swelling at site of injection Lt leg; unusual crying for more than 5 hrs w/in lst 24 hrs.
did not feel great" the day afterwards.; soreness in his left arm.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in his left arm.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in his left arm.). At the time of the report, FEELING ABNORMAL (did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in his left arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-404030, MOD-2021-404031 (Patient Link).
Whelts developed within 4 minutes of vaccine administration. Whelts concentrated on R thigh with exception of one whelt on L cheek; whelts closest to varicella site-only site to also have edema/erythema. Benadryl 10mg IM 24 minutes after vaccinations; Benadyrl 12.5mg po q 6h prn whelts.
Received vaccine @0635, during  observation period developed rash on left arm and neck, patient transported to ED after receiving Epi and Benadryl at vaccine clinic. While in ED, received IV decadron and Famotidine.
patiet did not experience any reaction; his son (the patient)was administered his first MMR-II shot"five months ago at 15 months of age and was accidently given another shot today 4/17/2019; This spontaneous report as received from a consumer (patient's father) regarding to a 20 month old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter described that, on an unspecified date in (approximately) November 2018, five months ago at 15 months of age, his son was administered his first measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and was accidentally given another dose today on 17-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose 2 (strength, dose, frequency, route lot# and expiry were not reported) for prophylaxis (inappropriate schedule of product administration). The patient father stated that his son did not experience any reaction (no adverse event). The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Arm swollen and itchy 1.5 weeks later. Still feeling dizzy, light headed occasionally and difficulty breathing at times
Pt. developed generalized itching after injection.   Treated with Zyrtec 10mg PO x 1 with resolution of symptoms.
pt admitted to hospital with SOB; pneumonia; positive for COVID; septic shock and sepsis; AHRF; transferred to ICU; pt's condition worsened requiring intubation; ABX given; condition continued to deteriorate; transitioned to in-patient hospice care where she passed away
Patient presented to our clinic site for her 2nd COVID19 vaccine.  It had originally been scheduled at that location but then moved nearby, as this site was now a site for a 5-11yo COVID19 vaccine clinic.  The child was first given a 10mcg dose of the Pfizer vaccine by accident.  Then, per the CDC guidelines at the time, she was immediately given the full 30mcg dose.  Patient and mom were made aware of the mistake, counseled on the plan and recommendations, agreed with plan, and have reported no side effects to us.  Of note, our clinical team have completed a causal analysis to identify many systemic changes we can make to avoid wrong dosing.
This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. There was no information about the patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with the first GARDASIL 9 (dose, strength, route, lot# and expiry date were not reported). On an unknown date (also reported as "after receiving the GARDASIL 9)"), the patient experienced a knot on her arm. The knot went away after one week on an unknown date. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 dose: 0.5 ml, intramuscularly in the arm (strength, lot# and expiry date were not reported) for protecting patient against HPV and cancers. On an unknown date, the patient experienced a "knot" around the injection site on her arm and the "knot" was still appearing on her arm "3 weeks" after being vaccinated. The "knot" was similar to the "knot" which the patient experienced after first dose of GARDASIL 9. The "knot" on her arm was tender to the touch and she had a "tingling" sensation down her arm as well. No treatment was given for the events. The outcome of the events was unknown. The patient sought the medical attention by calling the doctor. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as the physician did not want tot be contacted regarding this adverse events.
Left forearm/thumb rash with mild pain. Seen for evaluation on 11/5/12 by physician and advised to start Valtrex if symptoms worsened.
October 22  - I was coerced into getting vax under threat of termination of employment.   October 27 - I received first vax at local Medical clinic and documented my concerns on the intake form. November 13 - I started getting sick with first virus I have had in years; ran fever, congestion, body aches, extreme fatigue, etc. November 15 - visited doctor in my medical group (GP was not available); was told to get the second shot if I was not running fever November 17 - still miserable from virus, but no fever; concerns document on intake form;  got second shot by "pharmacist"; within two hours was running a high fever and had textbook side effects until November 19, PM.   November 18 - took band aid off injection site and had a huge bruise; took pictures for at least 21 days of my entire upper arm as black and blue November 22 - visited functional medicine doctor and shared symptoms; indicated some sort of autoimmune response to this and expressed that this was unusual, including the massive bruise on my arm; gave me Vitamin C and immune boost supplements to help my immune system start to recover December 1 - went to doctor in medical group, seeking relief from cough from virus noted earlier; was told I am clearly responding in an inappropriate way to virus; nurse indicated I was not supposed to bruise from injection and that it was administered in the incorrect location December 3 - started having abdominal pain December 5 - abdominal pain was significant and struggled to walk December 6 - spent 11 hours in ER and was admitted to hospital with inflammation and infection associated with diverticulitis (new diagnosis); given heavy duty antibiotics and morphine for pain December 8 - released from hospital; given two antibiotics (cipro and flagyl); extreme exhaustion, disorientation, nausea, sweats, shakiness, shortness of breath, "brain fog"; was told diverticulitis is "inflammation," and multiple forms of inflammation are associated with this vaccine December 15/16 - self-determined to stop taking 10 day antibiotic treatment due to side effects December 20 - follow-up with functional medical doctor; I indicated I was not taking supplements because I was clearing my system of all drugs and supplements, to let it rest December 21 - follow-up with general surgeon from ER regarding diverticulitis diagnosis; wants me to get a colonoscopy; indicated that I am having clear adverse reaction to the vaccine, but cannot confirm it's all related to vaccine; suggested I talk to GP regarding any waiver for future mandates January 1 - started getting sick; noticed sore throat January 2- congested, fever, extreme exhaustion Presently - still have cold-like symptoms.  I have not been able to overcome the "brain fog," lack of focus, extreme exhaustion, some nausea, shakiness, occasional shortness of breath, and other symptoms I have had since getting this experimental drug.
No adverse Event; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
having to stay in bed; Aches; Chills; being very tired for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (being very tired for 3 days), VACCINATION COMPLICATION (having to stay in bed), CHILLS (Chills) and PAIN (Aches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 002B21A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high and Arthritis. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (being very tired for 3 days), VACCINATION COMPLICATION (having to stay in bed), CHILLS (Chills) and PAIN (Aches). At the time of the report, FATIGUE (being very tired for 3 days) had resolved and VACCINATION COMPLICATION (having to stay in bed), CHILLS (Chills) and PAIN (Aches) outcome was unknown.            concomitant medication include high blood pressure pills. Patient took some relief pills that she used for arthritis.
Initial pregnancy information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 32 years old female patient who received extra dose of ADACEL while she was pregnant. Gestation period: first dose at 27.2 weeks pregnant (6 months) and second dose again 4 weeks later at 31.2 weeks (7 months) pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 29-Jun-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5798AB. On an unknown date she also received a 0.5 ml dose of the same vaccine lot 5N2YG. It was a case of actual medication error due to extra dose administered and Vaccine exposure during pregnancy. ADACEL was given twice in 4 weeks. No AE symptoms stated or known. 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 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.
Patient noticed symptoms on 8/15/16. Patient has increasing red bumps that are itchy and painful. Patient was directed to use over-the-counter antihistamine, take 2 BENADRYLS at night, cooler baths/showers, no work until cleared at follow up office visit.
Initial report received from a health care professional (nurse) on 18 Mar 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: M100031) 0.5 ml dose intramuscularly on 18Mar 2011. The patient received only the Men conjugate component of MENVEO that was reconstituted with another diluent. No adverse events were noted following this medication error.
80 doses administered after the 30 day expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (80 doses administered after the 30 day expiration) 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 EXPIRED PRODUCT ADMINISTERED (80 doses administered after the 30 day expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (80 doses administered after the 30 day expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Two lot number involved: lot number: 022C21A expiry date:  23-Oct-2021 and 035C21A expiry date: 30-Oct-2021, neither have experience an excurtion prior this. No concomitant medications were reported. No treatment information was reported.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 2 (booster), single (Lot number: FF8841) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 09Apr2021 as dose 1, single (Lot number: 201A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Dec2021, outcome "unknown"; 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: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (COVID 19 Treatment) from 22Feb2023 to 27Feb2023.  No follow-up attempts are possible. No further information is expected.
Febrile to 39.4 was unable to work s/t work exclusion algorithm for one shift. Myalgias consistent with fever, relived by 600mg Motrin and sleep.