chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. Mild headache  2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the location of the shot (left upper arm) muscles are very  tender. It hurts when I put pressure. Unable to sleeping on my left side. 4. Mild stomach pain - typical feeling when I am having an allergic reaction.
Fever 100.1; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.1) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030214) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Fever 100.1) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever 100.1) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive (Positive) Positive. On 18-Mar-2021, Body temperature: 100.1 (Inconclusive) Inconclusive.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; Refrigeration excursions identified; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The patient received three doses of Moderna Covid 19 vaccine (Dose1, dose2 and dose3) on an unknown date intramuscularly in deltoid.  No treatment medication information was reported.  Refrigeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation. No adverse reactions reported to our knowledge for any of these patients.  The nurse reported a temperature excursion that had occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines had undergone several temperature excursions and may had been administered to patients.
1st shot given on 2/24 at 1400 second shot given 3/25 at 1110. Fever of 101, chills, body aches and a headache. Taken otc analgesics: Tylenol and Ibuprofen.
Bell's Palsy symptoms developed next day.  Seen on 3/9/2021 and prescribed steroid and antiviral.  Outcome is TBD.
developed a rash on her side; This is a spontaneous report from a contactable Pharmacist. An 82-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),  via an unspecified route of administration on an unspecified date, as first dose ,single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Pharmacist called on behalf of an 82-year-old female patient and reported that the patient received her first Pfizer BioNTech COVID 19 vaccine 21 days ago and developed a rash on her side. Pharmacist was now seeking information if it was ok for the patient to receive the second dose of the vaccine today. In response pharmacist was instructed that Pfizer was unable to make treatment recommendations for patients up to HCP decision. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829772 similar report from same reporter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "obese" (unspecified if ongoing); "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti-viral product Paxlovid for COVID 19 Treatment from 17Jan2023 till 21Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had 12 mo vaccines on 9-3-15. Tongue swelling (mild per mom) and hives following morning.
Constant low grade fever with production of green thick mucus discharge. No treatment other than albuterol nebulizer for asthma.
RECONSTITUDED WITH BACTERIOSTATIC SODIUM CHLORIDE 0.9% CUSTOMER DID NOT EXPERIENCE ADVERSE EVENTS
patient had been inadvertently vaccinated with an expired dose of 05ml of ActHib with no adverse event; patient had been inadvertently vaccinated with an expired dose of 05ml of ActHib with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Global Medical Information (Reference number: 00721637) and transmitted to Sanofi on 12-Aug-2021.  This case involves a 05-months old female patient had been inadvertently vaccinated with an expired dose of 05 ml of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered and overdose).  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 10-Aug-2021, the patient received 05 ml (once) dose of suspect HIB (PRP/T) VACCINE (lot number: UJ351AA and expiration date: 09-Aug-2021) via unknown route in the unknown site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used and overdose (latency: same day).  No adverse events were reported at the time of this report.  At the time of this report, outcome of the event was reported as unknown.  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.
Left arm hurt all night long on 10/17/05. On 10/18/05, had swelling, redness to elbow. Felt hot to touch and had redness. Went to ER evening of 10/18/05. Received IV antibiotics, Clindamycin, then orally.
Moderna COVID-19 Vaccine EUA Headache, slight fever, trouble breathing.   3/02, 3/03.  3/14, 3/18  fighting something very briefly; slight chills. 3/27 feel flush, sore throat for 3 days.  Took echinacea and sore throat gone in morning.
Redness and warm to the touch at the vaccine site two days after the vaccine was given.  The patient is using a cold compress.
Presented to ED approximately 4 hours after vaccination reporting throat tightness, chest heaviness, and red itchy eyes. She was given 4mg Decadron and 50mg Diphenhydramine IM. Slight improvement in ER. Sent home with prednisone.
Got COVID; Got COVID; Previous dose brand: Moderna; Previous dose administration date: 11Dec2021; Previous dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EL3247) and on 21Apr2021 as dose 2, single (Lot number: EL3247) at the age of 21 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Dec2021 as dose 3 (booster), single (Lot number: 060H21A) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 01Oct2022 as dose 4 (booster), single (Lot number: A3716313) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Dec2021, outcome "unknown", described as "Previous dose brand: Moderna; Previous dose administration date: 11Dec2021; Previous dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2023, outcome "unknown" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2023) Positive.
Pt recv vax on 11/18/98; on 11/19/98 pt exp erythema, warmth, tenderness at LA vax site
No adverse events reported. ERROR on administering a vaccine past beyond used date of 4/14/2022 on 4/18/2022 Patient was informed of error. Pfizer vaccine was re-administered on 4/20/22 @5:58pm.
Fatigue, muscle ache,headache, shortness of breath, chest pain,sore forearm,redness and knot at injection site
This spontaneous report was received on 17-MAR-2017 from a Registered Nurse referring to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On an unspecified dates, an unspecified number of unspecified patients were vaccinated with improperly stored doses of ROTATEQ lot # M025565 expiration 06-NOV-2017  (strength, dose number, dosage and route were unspecified. The vaccine was exposed to temperature of 49 °F; for time frame of 64 hours. There was no previous temperature excursion. No adverse effect was reported.   Additional information was received on 20-MAR-2017  from  a registered nurse  who reported some additional improperly stored  doses might have been given to unknown number of patients. No adverse effect reported. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1704USA004411:
Information has been received from a nurse practitioner concerning a male infant who on an unspecified date was vaccinated with Hep B (manufacturer unknown). On an unspecified date, the patient experienced an allergic reaction to the "hepatitis B vaccine". It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. No further information is available.
Client admitted to hospital for respiratory symptoms. Diagnosis - pneumonia - diagnosed with viral pneumonia. Cause or type unknown at time of death.  12/23/09 Discharge summary, hospital records received. Service dates 12/5/09 to 12/11/09. Assessment: Bilateral extensive pneumonia/acute respiratory distress syndrome. Acute hypoxia, respiratory failure. Anxiety/depression. Chronic anemia. Pulmonary hypertension. Right ventricular dysfunction.  Patient developed acute onset of fevers, chills, shortness of breath, productive cough. Decreased breath sounds. Patient admitted to ICU. On ventilator. Acute renal failure. Discharged to higher level facility.      12/23/09 Discharge Summary, hospital records received. Service dates 12/11/2009. Assessment: ARDS, multiorgan failure, thrombocytopenia, multiple arterial and deep venous clots right upper and left upper extremities, right-sided pneumothorax, hemodynamic instability, possible heparin-induced thrombocytopenia. Patient transferred from another facility intubated with left lower lobe pneumonia. Small pupils, nonreactive.  Crackles left chest. Hypotension. Bladder infection. Developed shock liver and acute renal failure with oliguria. Patient expired.
Suspected vaccination failure; shingles; Very painful.; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient got the vaccine and 2 years later hot shingles. The patient mentioned that, it did not always work but very painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Rash an body noted by mother the evening of 08/07/2006.  Rash was itchy.  BENADRYL with effect
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient was administered ZOSTAVAX (lot#, dose and route unknown) and BOOSTRIX on the same day in different arms on an unspecified date in February 2014. There was no concomitant medication reported. On an unspecified date, after the administration of ZOSTAVAX and BOOSTRIX, the patient sought medical attention at an unspecified physician. The patient reported to pharmacist that physician told her that she had swollen lymph nodes on both sides of her body on an unspecified date in February 2014. Treatment reported was that physician "bandaged arm" in which the ZOSTAVAX was administered. The outcome of the events was unknown. Additional information has been requested.
Chills and fever, headache and cold symptoms morning after. No symptoms after day 2 morning.
Pt experienced pain with the injection and continues to have ongoing pain in left deltoid where injection was given. Ibuprofen relieves it, but it comes back as that wears off and continues to be very painful.
Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  Excursion about a month ago was observed where excursion duration was found to be approximately 7 hours. HCP also mentioned that the excursion duration was 7 hours instead 5 min (previously stated). The vial was refrigerated at the time of excursion. Maximum temperature reached was 64 degree fahrenheit. There were no changes in vaccine state on visual inspection. It was reported in pertinent detail that at the time vials were unpunctured.  Patients have been administered from these vaccines but patient experienced no adverse events post injection.
Afternoon of shot arm got more & more swollen so went to ER & got shot of morphine & told to go home & ice it. Called in morning complained of area 4"x6" hard hot & extremely painful prevented sleep even with morphine. Saw Dr & had X-ray of site which was Neg. also did blood cultures that were negative. Spoke to her 11-29-12 said she remains on BENADRYL, PEPCID and NORCO but it is getting better.
Immediately following vax, the pt broke out in a rash on her butt. She then developed red, itchy bumps on her legs and arms. The pt was seen in the hospital and was said to have molluscum contagioscum. The hospital stated that she was contagious and that the rash would go away on its own. The pts condition persisted. No further information is available.
Covid Positive on 02Aug2021; Covid Positive on 02Aug2021; Colleague developed sore throat; runny nose; This is a spontaneous report from a contactable Nurse. A 44-year-old female patient (pregnant: unknown) received second dose bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Lot Number: EN6199), via intramuscular on an unspecified date as DOSE 2, SINGLE and first dose bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route on 24Feb2021 as DOSE 1, SINGLE for COVID-19 Immunization (at the age of 44 years). Medical history and concomitant medications were not reported. It was reported unknown if other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient on 02Aug2021 experienced Positive on 02Aug2021 and colleague developed sore throat, runny nose. The patient underwent lab tests included SARS-CoV-2 test: positive on 02Aug2021. The patient received any treatment for adverse event as unknown. The patient adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were recovering.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
1/16 initial redness at injection site, headache, fatigue- resolved by 1/19  1/24 injection site itching 1/25 injection site bright red across and up arm toward shoulder, hot, experienced dizziness, may pass out, diarrhea, nausea, severe headache  - not a normal local reaction at injection site  1/29 area still red, itching other symptoms have resolved
Stomach cramps, back ache, fever, fatigue,.  Urgent care prescribed cirproflaxin and tylenol
patient was around 69 years old or 70 years old when patient received menactra dose with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a physician  This case involves Elderly (74-75 years of age) and unknown gender patient who received Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] dose when patient was around 69 years old or 70 years old with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (lot number, expiry date, dosage- not reported) via unknown route in unknown administration site for Immunization, when patient was around 69 years old or 70 years old with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Information on the batch number was requested  Reportedly, Doctor asking if MENACTRA is a life-long meningococcal vaccine? Doctor also asked if a patient received MENACTRA before, does the patient still need to get it or not? He also asked if less than 4 years have elapsed since the prior dose, can the patient still get another dose?  Action taken was 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 guidelines. 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.
6-30-09 4:45 pm pt. c/o tingling in arms after injections of MENACTRA and HPV. Pt also given Tdap. Pt asked to wait twenty minutes to make sure she had no adverse reaction. Pt getting ready to leave at 5:30 and almost fainted. Pt placed in wheelchair given ammonia inhalant and taken to the hospital ER by wheelchair.
Pt stated she had not received ZOSTAVAX before. No adverse reaction. Once patient was informed of 2nd dose, she still believed she hadn't received the first dose.
Pt recvd vax on 25MAR92 & 2 days p/vax exp fever, h/a, knee & elbow pain; 3 days later pt recovered; No further details were provided;