chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sinus and lung congestion; Backache; Sinus and lung congestion; Scratchy throat; Sneezing; Mild cough; offlabel; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 10:00 as dose 5 (booster), single (Lot number: OH9694) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TELMISARTAN; AMLODIPINE; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose number: 1, product: COVID 19, brand: Pfizer, lot number: EL1283, administration date: 16Jan2021, administration time: 08:00 PM, vaccine location: Right arm), administration date: 16Jan2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 2, product: COVID 19, brand: Pfizer, lot number: EL9265, administration date: 15Feb2021, Administration time: 08:30 PM, vaccine location: Left arm), administration date: 15Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 3, product: COVID 19, brand: Pfizer, lot number: FD8448, administration date: 31Aug2021, administration time: 09:30 AM, vaccine location: Right arm), administration date: 31Aug2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 4, product: COVID 19, brand: Pfizer, lot number: FJ1615, administration date: 30Jan2022, administration time: 10:00 AM), administration date: 30Jan2022, when the patient was 74-year-old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 10Sep2022 at 10:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 10Sep2022 at 10:00, outcome "unknown", described as "offlabel"; BACK PAIN (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Backache"; COUGH (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Mild cough"; THROAT IRRITATION (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Scratchy throat"; PULMONARY CONGESTION (medically significant), SINUS CONGESTION (non-serious) all with onset 11Sep2022, outcome "not recovered" and all described as "Sinus and lung congestion"; SNEEZING (non-serious) with onset 11Sep2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pulmonary congestion, back pain, sinus congestion, throat irritation, sneezing, cough. Clinical information: Received other vaccine same date vaccine on 10Sep2022 (dose number: 2 and dose number: 3). Other vaccine in four weeks was no. Other medications in two weeks were daily Vitamin v. No covid prior vaccination.
Patient presented the day following the vaccination with an inflamed and blistered administration site. Patient then received LEVAQUIN therapy from another pharmacy.
Left arm swelling, high fever, leukocytosis, pain, c/w SIRS/sepsis failed initial ROCEPHIN, admitted treated then with Vancomycin with improvement suspect cellulitis and localized reaction.
Local induration and arm swelling x4d; fever and malaise x5d; arm itching (ongoing) Advised tylenol, oral antihistamine.
Chills, fever, joint pain in all joints, full body muscle aches, nausea, vomiting.
Father requested findings be reported: 2 weeks after the vaccine, a CBC showed echinocytes, basophilic stippling and polychromasia. The follow up received on 11/5/02 states, "9/11/02-lethargy, loss of appetite, fever of 102 F, duration 12 hrs. 9/13/02-pre-op CBC for cochlear implant showed echimocytes basophilic stippling and polychromasia. 10/9/02-Dr calls with results, suspects lead poisoning. 10/11/02-lead test and CBC slides showed no lead and blood abnormalities disappeared."
Coughing, malaise, difficulty sleeping, has visited Dr. twice, no treatment recommended by them.
COVID-19; received a vaccine that was past the use by date by two days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine that was past the use by date by two days) and COVID-19 (COVID-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 010A21A and 032L20A) for COVID-19 vaccination.     She had no allergies to medications, food and other products. No medical history relating to mentioned adverse event was reported. She did not had any acute or chronic illnesses at the time of vaccination. She did not received any other manufacturer vaccine one month prior of receiving Moderna Covid-19 vaccine.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine that was past the use by date by two days). On 01-Jan-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine that was past the use by date by two days) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, COVID-19: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.  Patient did not seek medical care (office visit, urgent care, ER or hospitalization) for adverse event.  Company comment- This spontaneous case concerns a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 25 days after receiving the third dose of mRNA-1273 Vaccine.  Expired product administered was also reported in the case. No further information was provided. Outcome of the events was recovered at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 25 days after receiving the third dose of mRNA-1273 Vaccine.  Expired product administered was also reported in the case. No further information was provided. Outcome of the events was recovered at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
The vaccine that was administered was expired. RN, failed to waste/discard of the unused vaccines from Monday 08/23/21.
Per patient, she got dizziness, neck pain, fever, muscle aches, and shivering about 8 hours after receiving the immunization
Left shoulder injection, Swollen/red/painful injection site nausea headache fatigue body soreness
DIED; This spontaneous report received from a consumer via Communication concerned a 32 year old male of an unspecified race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death after receiving the vaccine. It was unspecified if an autopsy was performed or not. It was reported as "(32 years old) died less than 24 hours after receiving the Johnson and Johnson vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221106251- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Day 11 post vaccines - rash on L thigh. Day 12 post vaccines - rash enlarging. RX Clindamycin for possible cellulitis.
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. On 28-Dec-2011, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 19-Mar-2012: reporter's information and it was reported that the patient did not have any adverse events.
Client presented for 1st dose Pfizer vaccination. 10 minutes after vaccination reported tingling tongue and "medicnal taste" in mouth. Lips felt "strange". BP176/81;P 67. Able to swallow. Respirations regular at 16. History of allergy to pain meds and coumadin. Repeat BP 153/69.  Still felt symptoms but no worsening. No visible swelling of tongue or lips. Third BP 20 minutes after initial onset was 138/67. Two family members present agreed to take client to nearby Urgent Care for further evaluation.
Pt recvd 1st dose of vax 3MAR92 & next day devel soreness @ inject site; 4 to 5 days p/vax exp aching sensation & stiffness of knee joints & lethargic & tired;
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 43 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 12Sep2023 to 16Sep2023.
syncope about 3 minutes after dose administered.  Patient was in reclined chair and recovered quickly.  Paramedics were called and they assessed her in the store.  Patient declined further treatment, walked out of the store on her own, and a relative drove her home.
On 03-14-2021; I was heavily medicated and did a lot of preventative treatment at the time I received my second vaccine. This time my symptoms were mild although I still had itchiness to my skin, had a rash and hives. Since I was already on mediation my symptoms only lasted for one day or two then my symptoms went away.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 26 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2021 as dose 1, single (Lot number: 027B21A), in left arm and on 04May2021 as dose 2, single (Lot number: 017C21A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: Sep2022, stop date: May2023; TRAZODONE, start date: Sep2022, stop date: May2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jan2022, outcome "recovered with sequelae"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered with sequelae" (May2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 28Apr2023 to 02May2023.
GROGGINESS; FELT SOME SHIVERS; SLIGHT ARM PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced grogginess, felt some shivers, slight arm pain, fever, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt some shivers, fever, fatigue, grogginess and slight arm pain was not reported. This report was non-serious.
Information has been received from a physician who received an e-mail that was addressed to all physicians from another physician, a pediatric neurologist. He stated in e-mail that one of his patients experienced seizures after GARDASIL. The patient outcome was not reported. Upon internal review, seizures were considered to be an other important event. Additional information has been requested. This is one of several reports received from the same source.
Feels awful all over; Achy all over; Pain at injection site; Redness at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels awful all over), MYALGIA (achy all over), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 22-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced FEELING ABNORMAL (Feels awful all over), MYALGIA (achy all over), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (Feels awful all over), MYALGIA (achy all over), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and HEADACHE (headache) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported. The patient was treated with ibuprofen.
About a day after vaccination, patient had bruise-like marking on her left arm at injection site. Looked bruised bluish/purple/reddish colored. But patient states she has no pain, no soreness, no swelling. Pt saw Dr and was told it's a bruise from vaccination but no infection. Everything is fine. Just wait for it to go away.
Sore throat and fatigue for a couple of hours, a couple brief feelings of nausea, red eyes with a heavy discharge (phlegm) a for approximately 12 hours, headache which lasted for approximately 10 hours.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 31-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
This serious initial spontaneous case initially received on 29-Mar-2017 was reported by other health professional (nurse) and concerns a 26-year-old adult female patient. The patient had received flu shot (name of vaccine unspecified) which was given long ago. It was reported that prior to vaccination patient's immune status was normal. On 08-Oct-2016, the patient was administered with FLUCELVAX QIV (dosage: 0.5ml, form: solution, batch number: 185327, route of administration: intramuscular, expiration date: 30-Apr-2017). On 24-Mar-2017 after administration of FLUCELVAX QIV, the patient being diagnosed with Influenza Type A (Vaccination failure) and on an unspecified date patient experienced fever and chills. Relevant tests included nasal swab test, positive for influenza A. Batch review report (reference number: 1021160 received from quality assurance department on [02-Jun-2017]: Based on the document review, it was stated that the concerned [FLUCELVAX QIV] batch number [185327] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Outcome of the event influenza Type A was recovered / resolved on 29-Mar-2017. The reporter assessed the "lack of efficacy" and "Influenza Type A as non-serious. The reporter assessed the causality of the events as related. Follow-up report received on 25-Apr-2017: Patients age at vaccination was updated, relevant tests include nasal swab (positive for influenza A), fever and chills were added as symptoms. Follow up report received on 02-Jun-2017: Vaccine administered date was updated from 28-Sep-2016 to 08-Oct-2016. Expiration date was added as 30-Apr-2017, Batch review report was added. Follow up report received on 07-Jun-2017: Added historical vaccine details. Significant case correction received on 20 Jun 2017: Added follow up justification, coded flu shot as historical drug, lack of efficacy was coded to vaccination failure, first reference number added, confirmation of receipt was attached in additional information.
I received the Hep A and Hep B vaccine around 5pm. Hep A was in the Right arm and Hep B was in the left arm. Also got a PPD in left forearm.The nurse who gave me the vaccines was very thorough - I commented on it to her - she checked and rechecked the vaccine bottles before drawing them up and administering them to me. I did not feel good after the vaccines, but that was to be expected. Wed (next day) I just did not feel good at all. That afternoon I started having bad aches on and off, but I just ignored them. Wed nite between 12am and 3am, I had a horrific pain to my mid spine area (like I had never had before- it woke me up) and it radiated around to my belly button and I had horrible abdominal pain in that area of my abdomen.  I remember thinking to myself - "Every fiber of my being hurts." AND, it was not like the flu, it was different, but hard to describe. I continued feeling very bad on Thursday and called out of work for the first 12 hrs of my shift. I was hoping to get better and go in the last 12 hrs.  Again, I cannot describe how horrible I Felt. Thursday nite about 4am, I got out of the bed to go to the bathroom and could not stand up. At first my head spun a little bit, but then stopped. (Note - I am used to getting up quickly and abruptly out of bed ALL the time with my job.) As I tried to walk, I fell to the left and could not walk. My husband heard me banging around falling on things and woke up. I said I cant walk right. He had to help me to the bathroom and back. I was concerned that I might be having a stroke and did the stroke scale tests. I passed them, but was still concerned what if this was just the early stages and I didnt want to miss that 3-4 hr window of getting to the hospital. I consulted a friend, an NP and she suggested I go to the hospital. I told her I owed the hospital enough and unless I was sure I was having a stroke I would rather not go. We talked about it more and decided it was not a stroke. I kept watch and tried to walk after that and it got better. I still could not walk straight. I felt sure it wasnt a stroke and therefore went to sleep. I woke up the next morning and a small amount of it was still there and called out the last 12 hrs of my shift. I was told I could take a benedryl and it may help, so I did and went bk to sleep. By the next morning I was doing much better all the way around.  I noticed I was a little weak when I tried to do alot, but otherwise I was ok.  NOTE: A co-worker of mine, who is in school stated he also has taken the Hep B vaccine a couple of times and he had the same horrific pains that I did. He did not have the Vertigo or inability to walk that I did.
Developed vesicular eruption in crops one day after 2nd dose of VZV. No sick contacts. No complications.
4/30/04 Site tender, hot, welt forming. Fever onset 6:00 PM (102 degrees). 5/1/04 Welt enlarging, swelling of arm to the elbow, fever, continuing. Use of ice packs and Ibuprofen. Welt enlarging. Call ER and was told to use 20mg of Prednisone for 3 days. 5/2/04 Welt enlarged to 11.5cm, fever continues. 5/3/04 Fever was down, swelling continues but I went to work. Became weak, dizzy, short of breath. Was seen by doctor and given steroids by IV. No improvement so was put in extended observation for 24 hours. Treated with IV steroids every 4 hours. Welt was going down as was swelling. BP elevated and severe headaches. 5/4/04 Released from hospital; improving by the hour. 5/5/04 Returned to work.  Nurse follow up on 06/21/04 states: "Review of discharge summary indicates allergic reaction to vaccine  systemic and serum sickness-like reaction."
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 3 (booster), single (Lot number: gh9693) at the age of 69 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
lEFT THIGH AT IZ SITE SWOLLEN AND RASH DEVELOPED AT SITE. RASH THEN SPREAD THROUGHOUT BODY.