chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure running low in morning; coughing up clear or white mucus; coughing up clear or white mucus; lost her voice; congested,getting more congested; dry cough; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested,getting more congested), COUGH (dry cough), COUGH (coughing up clear or white mucus), APHONIA (lost her voice) and SECRETION DISCHARGE (coughing up clear or white mucus) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (every year). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Pneumonia and Atrial fibrillation. Concomitant products included LEVOTHYROXINE, AMIODARONE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), APIXABAN (ELIQUIS), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), METOPROLOL SUCCINATE and COLESTYRAMINE (CHOLESTYRAMINE) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced COUGH (dry cough). On 02-Dec-2021, the patient experienced NASAL CONGESTION (congested,getting more congested) and APHONIA (lost her voice). On 03-Dec-2021, the patient experienced COUGH (coughing up clear or white mucus) and SECRETION DISCHARGE (coughing up clear or white mucus). On an unknown date, the patient experienced HYPOTENSION (blood pressure running low in morning). At the time of the report, NASAL CONGESTION (congested,getting more congested) had not resolved and COUGH (dry cough), COUGH (coughing up clear or white mucus), APHONIA (lost her voice), SECRETION DISCHARGE (coughing up clear or white mucus) and HYPOTENSION (blood pressure running low in morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) blood pressure has been running low in the morning.         Patient stated she had no drug of food allergies and took other vaccines too.  Treatment medications reported that going to use Mucinex EX and cough drops.
headache; tiredness; muscle pain; chills; decresed appetite; fever; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2021 08:15 (Lot number: EN6203) at the age of 78 years as dose 2, single and intramuscular, administered in arm left, administration date 04Feb2021 08:30 (Lot number: EM9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hyperparathyroid", start date: 1954 (ongoing), notes: Age 12; "polycystic ovary syndrome", start date: 1954 (ongoing), notes: Age 12. Concomitant medication(s) included: SPIRONOLACTONE taken for polycystic ovaries, start date: Jul2021 (ongoing); INFLUENZA VACCINE, administration date 20Oct2021. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "tiredness"; MYALGIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "muscle pain"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "chills"; APPETITE DISORDER (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "decresed appetite"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "fever"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "joint pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Symptoms occurred within 12hours after vaccine administered. The symptoms lasted between 24 and 48 hours without recurring symptoms afterwards. patient did not report symptoms to her doctor nor to the hospital that administered since she was sure that they would stop. Blood type was reported as A-. family medical history relevant to AE was reported as unknown. relevant history reported as none. specific relevant test for thromboembolic with thrombocytopenia was reported as none. autopsy information reported as NA.it was unknown whether patient received any prior vaccination(within 4 weeks).Patients medical history (including any illness at time of vaccination) were reported as None.  No follow-up attempts are possible. No further information is expected.
Itchy rash all over body 1 day after vaccination, advised to give Benadryl and Aveeno or baking soda bath
classic hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (classic hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BUPROPION from 12-Jan-2021 to an unknown date for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced URTICARIA (classic hives). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (classic hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Hospitalization for heart failure exacerbation, with incidental COVID-19 on dates 9/13/22-9/16/22. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Dull headache behind the right eye; Dull headache behind the right eye; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HEADACHE (Dull headache behind the right eye) and the second episode of HEADACHE (Dull headache behind the right eye) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis, Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Rheumatoid arthritis, Ankylosing spondylitis and Ulcerative colitis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK. On 31-Jul-2021, the patient experienced the first episode of HEADACHE (Dull headache behind the right eye). On an unknown date, the patient experienced the second episode of HEADACHE (Dull headache behind the right eye). At the time of the report, last episode of HEADACHE (Dull headache behind the right eye) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624118 (Patient Link).
Pt to ED for Respiratory Distress, COVID Test Resulted + CT: Pulmonary pleural findings persist at right base with interval improvement. Pt intubated and in ICU: Sepsis with UTI with pneumonia
This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route were not reported) lot # reported as N0003826 with expiration date of 14-OCT-2019, for prophylaxis. The temperature of the GARDASIL 9 was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002251: US-009507513-1705USA003154: US-009507513-1705USA003157: US-009507513-1705USA003150:
Information has been received from a pharmacist with follow-up from an RN concerning a female pt who was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L) at 09:00 on approx. 1/7/02. Subsequently, within 3 hours of vaccination, the pt developed an allergic reaction and complained that the site of injection was sore and red. The pt was seen and given Benadryl. The pt was kept in the office for several hours for observation. The injection site appeared to be getting worse, so the physician ordered that pt to receive a dose of epinephrine. It was reported that the pt has not had any more problems and subsequently recovered. The reporter indicated that this was the 2nd person to experience reaction in this fashion to this vaccine from this vial. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was reported that 2 or 3 people received doses without incident. Another pt (WAES 0201USA00515) had a similar reaction following receipt of this vaccine. Upon internal review, the pt's events were considered to be "Other Important Medical Events". Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 at 13:00 as dose 4 (booster), single (Lot number: G51514) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 13:00 as dose 1, single (Lot number: EN6Z08), in left arm, on 31Mar2021 at 18:00 as dose 2, single (Lot number: ER8734), in left arm and on 03Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FE3594), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 26Apr2023 to 30Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182689 Same patient, Same reporter, Different product, Different events;
Patient took 1st dose of Covid Vaccine and started to feel light-headed, nauseous, and blood pressure was low. We called EMT's and after they evaluated her and patient refused any further services.
COVID arm (as described by medical professionals) large raised lump in injection area, swelling, pain, itchiness
I experienced diarrhea which is the result of a trip, I had weight loss and it was all because of a parasite.
Had arm pain when got vaccine; Pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Had arm pain when got vaccine) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included LORATADINE for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Sep-2020 and the estimated date of delivery was 27-Jun-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On an unknown date, the patient experienced VACCINATION SITE PAIN (Had arm pain when got vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 26-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Had arm pain when got vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 31 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her second dose of mRNA-1273 vaccine 3 months after she had a positive pregnancy test. Also, she experienced an event of arm pain (vaccination site pain). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: This case concerns a 31 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her second dose of mRNA-1273 vaccine 3 months after she had a positive pregnancy test. Also, she experienced an event of arm pain (vaccination site pain). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
16-year-old child was incorrectly given the moderna vaccine; Eczema has flared; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old child was incorrectly given the moderna vaccine) and ECZEMA (Eczema has flared) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced ECZEMA (Eczema has flared). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old child was incorrectly given the moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old child was incorrectly given the moderna vaccine) had resolved and ECZEMA (Eczema has flared) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up information received on 09-Apr-2021 included batch number of vaccine and contact information of reporter updated. On 25-May-2021: Follow-up information received on 25-May-2021 included second dose details, new event added and action taken with suspect updated.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 01-OCT-2013 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # 0491AE, EXP date 15-SEP-2013, dose and route was not reported). No adverse effects were reported. It was unknown if patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
Received Pfizer covid 5-11year vaccine as dose 2. Dose 1 was Moderna 6mo-5yr.
Days after getting Hep A and Tdap in left arm.  Red rash 9 x 9 cm with mild warmth.  Resulted in a followup visit to doctor on 7-6-10.  Antibiotics were rx if worsening symptoms to start and finish (Bactrim).
Post vax, the physician reported that on 10/10/00, the pt just wasn't himself. Pt claimed it was the Flu shot that made him ill, however, the doctor believes pt was passing a gallstone. The pt was hospitalized on 10/11/00, for acute hepatic injury, gallstones is the dx. Additional information received on 10/16/00, states that the reporting physician reaffirmed his belief that pt's symptoms were secondary to passage of a gallstone.
Triggered an asthmatic response, restricting breathing. Occurred 9 hours after vaccine administration. Solved with prescribed Albuterol inhaler, two puffs of 90mcg spaced 1 minute apart.; Triggered an asthmatic response, restricting breathing. Occurred 9 hours after vaccine administration. Solved with prescribed Albuterol inhaler, two puffs of 90mcg spaced 1 minute apart.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 23-year-old male patient received first dose of BNT162B2 (PFIZER BioNTech COVID 19 Vaccine, Solution for Injection, Lot number: EP7533), via an unspecified route in the right arm on 31Mar2021 at 09:15, as a single dose for covid-19 immunization. Medical history included asthma and allergies. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient has not been tested for COVID-19. On 31Mar2021 at 18:15, 9 hours after vaccine administration, patient experienced an asthmatic response and restricting breathing. Therapeutic measures taken as a result of the events included albuterol inhaler, two puffs of 90mcg spaced 1 minute apart. The clinical outcome of the events was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
suspected vaccination failure/shingles on face, had the shot; shingles on face; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a shot several years ago and had shingles on his/her face. The patient stated that he/she did not knew that he/she needed another one after so long but he/she would be getting one as soon as he/she can. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.  The follow-up could not be possible as no contact details were available.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient (age and gender was not reported) and reported where you screw the needle on, there is a circular plastic piece, separate from the syringe itself that is very loose, while he/she received vaccine TYPHIM VI (lot number: N1K81 and expiry date: 19-Oct-2019) (dose, dose in series, route and site of administration was not reported). It was case of potential medication error due to needle issue. 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. List of documents held by sender: none.
Chest pains, whole body muscle pain, fever,  severe fatigue, nausea, lack of appetite, migraine, & chills and sweats
Bruise about the size of a quarter at injection site; Bruise about the size of a quarter at injection site and very painful still after 4 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration in the right arm on 18May2021 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included GERD (Gastroesophageal reflux disease) and gastritis. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included lansoprazole (PREVACID), diphenhydramine hydrochloride (BENADRYL) and vitamins nos (DAILY VITAMIN) all for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021, the patient experienced bruise about the size of a quarter at injection site and very painful still after 4 days. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the events bruise about the size of a quarter at injection site and very painful still after 4 days was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Per patient had episode where she felt light headed and "blacked out" but remained conscious. Noted left arm was twitching uncontrollably. Had abnormal sensation on left side for several minutes after with confusion for at least 1 hour after completion of episode.
Pt recvd 1st dose of Hep B vax on 23AUG91 & 2 days later exp severe pain in lt shoulder which radiated down into thoracic nerve into back; 1 wk p/vax pt devel a low grade fever 99.6;
pt recv vax & exp inj site redness;this is one of ten pt from this site who exp the above rxn;
pt recv vax 19DEC90 & devel a fever; 20DEC90 devel a swollen rt knee on the same side as the anterior lateral thigh where inj was given; MD dx pauciarticular JRA; lab eval in 1991 revealed ESR 15, IgA less than 6.7 (deficiency), ANA pos;