chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anxiety attack, nightmares 2 hours after SPV. Aggravated by epinephrine. Vital signs, exam: no suggestion of anaphylaxis.
Swelling below the injection site; Itching below the injection site; Redness below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling below the injection site), VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling below the injection site), VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling below the injection site), VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) outcome was unknown.            No Concomitant Medications were provided. No Treatment history was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Non significant follow up appended.
After first day:  Muscle aches, headache, feeling cold, temperature at 99.5 degrees, tired.
This spontaneous report as received from a physical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of GARDASIL. Approximately on 06-NOV-2015, reported as "is currently in the office", the patient received a second dose of GARDASIL 9. No adverse effects reported. Additional information has been requested.
Pregnant; This case was initially received via Agency (Reference number: US-irms-MOD21-126767) on 06-Apr-2021. The most recent information was received on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Aug-2020 and the estimated date of delivery was 08-May-2021. On 05-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 05-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. On an unknown date, the patient received a positive pregnancy test and date of conception was not provided.  On 05 Apr 2021, the pregnant patient was exposed to the mRNA -1273 vaccine. Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Patient route of administration added
I HAVEN'T BEEN TREATED ! .. ONE OF THE DRS TOLD ME THEY DONT KNOW WHAT TO DO.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, 1 total administered on 08-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-JAN-2022, the patient started to experience cough, sore throat, nasal congestion, light headedness and fatigue and later that same day tested positive using the Bi Nax covid-19 antigen test (suspected clinical vaccination failure, and suspected covid-19 infection). Symptoms had peaked but were still there as of 27-JAN-2022.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000214161.; Sender's Comments: V0:20220152330-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Initial and follow-up information has been received from a physician and nurse concerning a patient who in November 2007, was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot# 658395/0966U).  In November 2007 "within the last month," the patient developed a localized injection site reaction.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
FEVER, CHILLS  AND 48 HOURS OF MISERY  THEN 6 DAYS LATER PLEURISY
55 year old male with history rash following Smallpox vaccination and concern for adverse vaccine reaction presents for initial consultation. On 5 March of this year patient received Meningococcal conjugate and Typhoid killed injected vaccines. On 6 March he received Anthrax (dose #5) and ACAM2000 (re-vaccination; dose #2). Approximately 48 hours later he developed scattered vesicles (3-4) and pustules (2-3) over his forehead, chest, hip and back. Mild subjective fever. Denies arthralgias/myalgias and headache. Five days later he presented to Immunizations clinic where he was noted to have a major take at the vaccination site. His symptoms resolved over the course of the next 10-14 days without treatment; he feels that he has had continued recurrence of the lesions but admits that he has a history of chronic acneiform rash over his back. Denies residual scarring but notes some skin pigment changes at affected sites. He notes a linear "blister" over the right side of his waist that developed this weekend.
Redness & swelling (L) thigh - 3 cms. Redness & swelling (R) thigh - 1 cm.
Her legs are not wobbly but they do not feel strong; She feels warm; Where she got the inoculation (arm) is sore; 102 fever/ She feels feverish; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Her legs are not wobbly but they do not feel strong), FEELING HOT (She feels warm), VACCINATION SITE PAIN (Where she got the inoculation (arm) is sore) and PYREXIA (102 fever/ She feels feverish) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 032L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Her legs are not wobbly but they do not feel strong), FEELING HOT (She feels warm), VACCINATION SITE PAIN (Where she got the inoculation (arm) is sore) and PYREXIA (102 fever/ She feels feverish). At the time of the report, MUSCULAR WEAKNESS (Her legs are not wobbly but they do not feel strong), FEELING HOT (She feels warm), VACCINATION SITE PAIN (Where she got the inoculation (arm) is sore) and PYREXIA (102 fever/ She feels feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 102 (High) 102 fever.         The patient was taking Diabetic medication. Treatment information was not provided.
localized rxn @ site of inj p/4th dose in series;scratched by rabid cat;
Patient was given vaccine that had been stored in the refrigerator for greater than the recommended 30 days. The product was placed in the refrigerator on 4/13/2021 and the vaccine given 6/1/21, so after 47 days in the refrigerator. Moderna was contacted, but no further stability information was given or recommendations given by them. There are press releases from end of April that Moderna has stability data for storage under refrigeration for up to 90 days. Patient was notified, issue discussed, and pharmacists recommended she not repeat the vaccine.
Vaccinated on 10/9/07. One day after patient had soreness at the site and down into armpit area with swelling in front of armpit area. Patient taking IBU, is better, patient notified us this date, 10/12/07.
after 1st booster had  a bad reaction with 101 temp, lack of appetite, temperamental, fatigue, weak felt these symptoms for about 2.5 weeks. Saw my PCP, ran some tests which showed normal. Dr. stated it was a reaction from the 1st booster. After the 2.5 weeks or so started to feel normal again.
Left arm where vaccine administered and approximately 6 inches below vaccine site, with warmth, mild edema and erythema without clear demarcation, tense, not TTP; no skin breakage, fluctuance or drainage.
1hr p/vax pt exp tenderness @ inj site;p/a couple of hr pt devel h/a, malaise, & nausea which persisted @ the date of this report;
Itching reported 15-20min after injection no rash seen. IM Benadryl given. 15 min after Benadryl reported chills. Sent home. Took more Benadryl. Slept. Awoke at 4PM. Reported chest tightness. Unable to take deep breath. Sent to ER.
3/14/21 8am noted bruising and pain at injection site; caller reports she was not happy with the person who provided the vaccination; she feels the injection was given improperly
Presented on 6/21/2022 with chills and SOB; also reports cough, myalgias, nausea, vomiting, fatigue, congestion, and rhinorrhea. Breakthrough COVID infection.
Had a procedure done the same day, it hurt; 21YO received pediatric dose; 21YO received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of pain in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 16th December 2022, less than a day after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced pain, underdose and adult use of a child product. On an unknown date, the outcome of the pain, underdose and adult use of a child product were unknown.   The reporter considered the pain to be unrelated to Engerix B pediatric and Engerix B Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Dec-2022  Reporter's comment: The reporter said that the patient also had a procedure done on the same day and it hurt but clarified that this was not due to the vaccine but to the procedure. The reporter consented to follow-up. Additional supportive information: The patient inadvertently received a pediatric dose of Engerix B, which led to underdose and adult use of a child product. As per reported information the event pain was coded conservatively with causality no and for the further clarification query was raised.
Headache; Fatigue; muscle aches and severe body aches; massive migraine; felt like she had COVID19; extreme chills/freezing; fever; tenderness at injection site/same site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection site/same site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia in November 2020. Concurrent medical conditions included Drug allergy (Zithromax.), Breathing difficult (Only needed inhalers once in a while. Patient use them much more often.), Asthma and Heart disorder. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, QUINAPRIL for Blood pressure management, ROSUVASTATIN and METOPROLOL for Heart disease, unspecified, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at injection site/same site pain). On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (muscle aches and severe body aches). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency and IBUPROFEN for Migraine, at an unspecified dose and frequency. On 09-Apr-2021, VACCINATION SITE PAIN (tenderness at injection site/same site pain) and HEADACHE (Headache) had resolved. At the time of the report, MIGRAINE (massive migraine), FEELING ABNORMAL (felt like she had COVID19), CHILLS (extreme chills/freezing), PYREXIA (fever), FATIGUE (Fatigue) and MYALGIA (muscle aches and severe body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 102 (High) went up quickly and ran 102-104 for the next 48 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Current condition also included blood pressure NOS.  The patient stated that she felt up to starting work in about 4 days but was totally wiped out.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: The patient information, events, event outcomes and concomitant medications were updated.
pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045421A and 037A21B.) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown.            No treatment related information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-098384 (E2B Linked Report). This case was linked to MOD-2021-098353 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098384:Co-worker's case
pneumonia caused by covid-19; Galbladder issues; Inappropriate schedule of vaccine administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (pneumonia caused by covid-19) and GALLBLADDER DISORDER (Galbladder issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (pneumonia caused by covid-19) (seriousness criterion hospitalization), GALLBLADDER DISORDER (Galbladder issues) (seriousness criterion hospitalization prolonged) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 PNEUMONIA (pneumonia caused by covid-19) and GALLBLADDER DISORDER (Galbladder issues) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided.  It was reported that the patient is currently residing in a nursing facility and was informed by his nurse that on 26Apr2021 or 27Apr2021 he would be taken to get the second dose of the vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse referring to a 12 year old patient of unknown gender. On 06-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 3/16/98; post vax pt exp urticaria x24 hr
This is a spontaneous report from a contactable pharmacist based on information received by Pfizer from Merck & Co., Inc. (manufacturer control number 00219802). A patient of unspecified age, ethnicity and gender received PREVNAR (lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date as single dose for immunization. The patients medical history and concomitant medications were not reported. The patient experienced Wegener's disease on an unspecified date. Details were as follows: pharmacist reported that a patient who received a dose of PREVNAR "about a year ago" was diagnosed with Wegener's disease on an unspecified date after receiving the vaccine. No further information provided. The action taken with pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. The outcome of Wegener's disease was unknown. No follow-up attempts are possible. No further information is expected. Company clinical evaluation comments Current information is limited for full medical assessment, especially lack of complete medical history and concomitant medications. Based on the information available, the reported event of Wegener's disease more likely represents an inter-current medical condition that is unlikely related to the vaccination with PREVENAR. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Sender's Comments: Current information is limited for full medical assessment, especially lack of complete medical history and concomitant medications. Based on the information available, the reported event of Wegener's disease more likely represents an inter-current medical condition that is unlikely related to the vaccination with PREVENAR. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I had stomach pain, diarrhea, rectal bleeding. I went to the emergency room, where they ran a complete blood panel, CAT scan. The CAT scan came showing for colitis and my blood work came back for slight anemia. They sent me home with two antibiotics Flagyl and Cipro, advised that I follow up with my PCP and have a colonoscopy. I did have a colonoscopy in March, that came positive for polyps, bloating, residual irritation from the colitis attack. My doctor advised me that I may have another colitis flare.
Flue like symptoms; Aching and hurting of the whole body; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN (Aching and hurting of the whole body) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus, Hypertension and Cholesterol. Concomitant products included INSULIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN (Aching and hurting of the whole body) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN (Aching and hurting of the whole body) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included unspecified medication for blood pressure, cholesterol and vitamins.
Tinnitus  Pressure in head/headaches/swelling  Body Tremors  Blurry vision  Nausea  Vertigo Chest pain, heart burn, stomach pain Dry Cough
Injection site pain- first dose and second dose  Second dose only: Significant body aches for 24 hours (started at 3:30 am after 1:30 pm vaccine given)  Low grade fever Reduced appetite Nausea (started at 5 am on 1/29/2021)
Patient received Pfizer bivalent,  grey cap (booster dose), as a primary dose. Patient reported no side effects other than minor soreness at injection site.
08/01-Patient arrives to ED with c/o productive cough, fever, nasal congestion, fatigue, nausea without vomiting, and diarrhea beginning this morning at 0800.