chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eczema; Lost 30 pounds; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) and WEIGHT DECREASED (Lost 30 pounds) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Stress.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-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 ECZEMA (Eczema) and WEIGHT DECREASED (Lost 30 pounds). At the time of the report, ECZEMA (Eczema) had not resolved and WEIGHT DECREASED (Lost 30 pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ECZEMA (Eczema) and WEIGHT DECREASED (Lost 30 pounds) to be not related.    Patient reported that he searched it and found out that the eczema that he has been experiencing after the vaccine is from stress and lost 30 pounds going through all the stress with his wife.  No relevant concomitant medications were reported.  Treatment information included unspecified Cream.
Patient inadvertently administered 1st dose of Covid 19 vaccine to person under the age of 18. Patient administered 2nd dose of Covid-19 vaccine on 3/4/2021 with approval of medical providers.
Temp 102  10:00pm thru next day. Woke up with nausea in a.m.   1:30 a.m.36 hrs after injection woke up and was very dizzy and still dealing with dizziness. Buzzing in ears continual since
Presented  with feeling sick X 1 week, wife is also positive.  Dx with Covid PNA, no hypoxia.  Treated with abx and steroids.  Discharge home
Patient developed a right facial never palsy (Bell's palsy) one day after vaccination (first dose of Pfizer). Her symptoms are now resolving.
I was infected with COVID-19 as confirmed by a home administered Antigen test and administered PCR test; I was infected with COVID-19 as confirmed by a home administered Antigen test and administered PCR test; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Oct2021 07:00 (Lot number: FF8839) at the age of 35 years as dose 3 (booster), single, administered in arm right, administration date 18Feb2021 13:45 (Lot number: EL3247) as dose 2, single and administered in arm right, administration date 28Jan2021 13:45 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SUPER B COMPLEX [VITAMIN B COMPLEX]; MAGNESIUM. The following information was reported: IMMUNISATION (medically significant) with onset 28Oct2021 07:00, outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 12Jan2022 12:00, outcome "recovering" and all described as "I was infected with COVID-19 as confirmed by a home administered Antigen test and administered PCR test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Nasal Swab; (14Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Other medication in two weeks was reported as Multivitamin. Patient had no other vaccine in four weeks. Patient did not have covid prior vaccination. It was reported that patient was infected with COVID-19 as confirmed by a home administered. Antigen test and a (place)administered PCR test. The only symptom patient displayed was fatigue. Otherwise, patient would not have known patient had COVID-19.  No follow-up attempts are needed. No further information is expected.
Vaccine was given to patient that is 16 years of age - outside of manufacturer recommendation. No reaction noted. Call to Medical made, advised it is ok to administer "off label" and patient can obtain second dose.
Fever, body aches, headache since 11 p.m. on 1/27/21.  Continue to have symptoms as of 0830 a.m. 1/28/21.  Resting in bed.  Notified employee health office & will contact pcp & employee health if symptoms worsen.
bump on arm; bump on arm and it was hurting; arm hot; arm hurting-same side of injection; left arm - Vaccination site sore; Red at injection site; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (bump on arm and it was hurting), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE INDURATION (bump on arm), INJECTION SITE PAIN (left arm - Vaccination site sore) and INJECTION SITE ERYTHEMA (Red at injection site) in a 70-year-old female patient 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) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (left arm - Vaccination site sore), INJECTION SITE ERYTHEMA (Red at injection site) and INJECTION SITE SWELLING (swollen at injection site). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm hot) and AXILLARY PAIN (arm hurting-same side of injection). On 23-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (bump on arm and it was hurting) and VACCINATION SITE INDURATION (bump on arm). On 25-Jan-2021, INJECTION SITE INFLAMMATION (bump on arm and it was hurting), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE INDURATION (bump on arm), INJECTION SITE PAIN (left arm - Vaccination site sore), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE SWELLING (swollen at injection site) and AXILLARY PAIN (arm hurting-same side of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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.
headaches; fatigues; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and FATIGUE (fatigues) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and FATIGUE (fatigues). At the time of the report, HEADACHE (headaches) and FATIGUE (fatigues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided Concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non Significant Follow up received on 12-JUL-2021 contains confirmation as 10-JUL-2021 from query to safety.
Flare up of his Still's disease; This spontaneous case was reported by a consumer and describes the occurrence of STILL'S DISEASE (Flare up of his Still's disease) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Still's disease.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced STILL'S DISEASE (Flare up of his Still's disease) (seriousness criterion medically significant). At the time of the report, STILL'S DISEASE (Flare up of his Still's disease) outcome was unknown.            No concomitant medication provided.  Treatment information was included steroids.  Patient hasn't had a flare up since August of 2018.  Action taken with mRNA-1273 in response to the event was not applicable.  Company comment: 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.A; Sender's Comments: 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.A
Initial solicited report received on 12DEC2017  from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the above mentioned trial. This is a 21 year old male who received immunization with ACAM2000 03JUN2017. The patient had no prior cardiac or other relevant medical history. Other vaccines received within 30 days included immunization with BIOTHRAX on 21MAY2017. On 16JUN2016 (13 days after smallpox vaccine) the patient had an abnormal electrocardiogram, echocardiogram and troponin I (1.5). On 16JUN2017, he was diagnosed with acute pericarditis and heart failure. On 19JUN2017 he was diagnosed with myocarditis. No further information was provided.
pain; Knee replacement; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KNEE ARTHROPLASTY (Knee replacement) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced KNEE ARTHROPLASTY (Knee replacement). On an unknown date, the patient experienced PAIN (pain). On 29-Mar-2021, KNEE ARTHROPLASTY (Knee replacement) had resolved. At the time of the report, PAIN (pain) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Treatment medication was not provided. concomitant product was not provided
8 x 10 cm. area of redness and swelling left upper arm which had onset one day after he received BOOSTRIX and VARIVAX in that site. Assessment: Typical local reaction.
Mother states child developed rash on hands and feet. Pt was referred to a dermatologist. The child was dx with erythema multiforme. Treated with Diprednisone and Erythromycin. MD told mom condition due to Hep B vaccine.
got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A child female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Dec2021 (Lot number: FK5618) as dose 1 (tris), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: They got their Covid shot on 02Dec2021 and then they were due for their second dose but then they got Covid, tested positive for Covid on 03Jan2022. When they got Covid they did had headache and coughing (for clarification).  Investigation results were received for PFIZER-BIONTECH COVID-19 VACCINE. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111074 same product and event, different patients
Increased tinnitus ringing in ears - constant ringing since approx. 7 days after receiving vaccine
Persistent soreness at administration site with periods of intense pain. Limited range of motion associated with pain of lifting arm past a certain position. Currently being treated by methocarbamol with reported relief.
Initial case of medication error was received from a healthcare professional on 10 Feb 2014. A 2 month old infant whose demographics details, medical history and concomitant medication were not reported received, a dose of DAPTACEL vaccine on an unspecified date (Batch number not reported). It was reported that on an unspecified date patient received extra dose of DAPTACEL vaccine on 7 Feb 2014 and then another dose on 10 Feb 2014. No Adverse event was reported. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of event was unknown. List of documents held by sender: None.
It began to itch and became swollen and red. When I woke up this morning, there was no change in size or color, and it was still itchy.
Acute onset of neurological symptoms, occurred late evening immediately before emergency room visit.  Sitting at rest when left side of face went numb, severe tinnitus left side, dizziness, inability to walk straight, general feeling of anxiety - something very wrong.  Contacted nurse-assist line through medical insurer who directed me to emergency room care.  I was driven to emergency room where I was worked up for stroke. CAT scan done negative result. EKG non-ischemic. Treated with fluids and meclizine. Dr. attending- released after several hours as symptoms reduced, disequilibrium resolved. Directed to have MRI done to follow up. This was scheduled by PCP on 08/01/2022 and reviewed by Dr. on 08/11/2022.  He concluded that there were no residual areas of concern - negative result.  He stated due to symptoms that event was small ischemic stroke or TIA of brain stem.
He was put to bed but did not awaken at the usual time (about 2 AM) for feeding. It was then that mother found him in his bed,child was transported to the hospital.
This spontaneous report was received from a consumer refers to his son as approximately 12 year old male patient. Medical history and concomitant medications were not reported. On an unknown date in March 2016 the patient was vaccinated with first dose of GARDASIL (Lot, dose and route were not reported). On an unknown date in 2016, the patient experienced night terrors, sleepwalking an hour into each night and no awareness of why he was upset. On an unknown date, the patient sought medical attention. The patient did not had any laboratory tests performed. The patient did not received any treatment for the events. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 year old male pt who received Infanrix. On 6/10/04, the pt received the 1st dose of Infanrix, but dose number 5 in the DTP immunization series, in the left arm. On 6/10/04, the pt also received an injection of IPOL in the left arm. Approximately 1 day post immunization, on 6/11/04, the pt experienced an injection site reaction characterized as swelling, redness and warmth "in the arm". The pt was seen at a physician's office and was treated with ibuprofen (Motrin). The event "resolved in one week" on an unspecified date in 6/04. The nurse considered the events to be related to vaccination with Infanrix.
This spontaneous report as received from a 50 years old female consumer with no pertinent medical history and no drug reactions or allergies refers to herself. 3 weeks ago on approximately 20-NOV-2012 the patient was vaccinated with ZOSTAVAX (lot # not reported intramuscularly not subcutaneously prevention of shingles. Concomitant medications included AMBIZ, CELEXA and multiple vitamins. It was reported 3 weeks ago on approximately 20-NOV-2012 the patient felt an immediate shot pain from the injection site up to her neck area. She stated her arm and neck area felt as though it was frozen in position and it was hard and painful to move her left arm. No lab diagnostics studies were performed. The patient sought medical attention through office visit. At the time of report, the outcome of the events was unknown. Additional information has been requested.
This solicited report was received from the mother of a 15 year old male patient who enrolled in a Market Research study. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1 (strength, dose details, lot/batch #: unspecified). The patient's mother told that "I heard he may only need 2 shots instead of 3. I was waiting to hear from the Doctor what it would be and when we would get the second shot". Action taken was not applicable. Outcome was unknown. Causality was reported as related. Additional information has been requested.
Information has been received from a medical assistant concerning a female who on 08-JUL-2008 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck) (lot # 662294/0715X). On 15-JUL-2008 the patient developed a mild case of chicken pox. The patient's body became itchy with blotches on her legs and red spots on her face. Her chest was itchy but there was no rash on her chest. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient given IM doses of PENTACEL and PREVNAR 13, oral ROTATEQ, fol. well at exam. Three hours later developed diffuse and signif urticaria. No other significant symptoms, no vomit, no fever, no resp. sx.
Starting about 6 hours after vaccination, loud buzzing noise that appears to be in top of head and ringing in left ear. This has been consistent to this date since the first vaccine.
Generalized sz lasting approx 20min on 7MAY91 in AM seen in ER; very irritable normal neuro exam admitted for observation;
Facial swelling, eyes swollen, mouth dry, coughing lips swollen, rash on abd - ambulance called -> ER - Reaction happened within 1 hour of administration - BENADRYL, Epipen - Rx for steroids.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: PATIENT HAS A HISTORY OF DIZZINESS/FAINTING POST VACCINATION.  PATIENT BEGAN TO EXPERIENCE DIZZINESS APPROXIMATELY 5 MINUTES POST VACCINATION.  PT DID NOT FAINT, PT LAID ON FLOOR AND LEGS WERE ELEVATED. DIZZINESS RESOLVED WITHIN 5 MINUTES.
pain in your ears; long term headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of EAR PAIN (pain in your ears) and HEADACHE (long term headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (pain in your ears) and HEADACHE (long term headaches). At the time of the report, EAR PAIN (pain in your ears) and HEADACHE (long term headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs are not given. Treatment information not provided.   Reporter did not allow further contact
Moderna COVID-19 Vaccine   High fever - 101.2 Body aches Chills - body shivering   Took x2 Advil/Tylenol combo pills every 8 hours
Redness and swelling of right deltoid. Exam reveals 8 cm x 10 cm swelling - erythemia, and enduration. No fever.
Had pneumonia Vaccine about 5 years ago and arm swelled up for almost 6 months and was red; Had pneumonia Vaccine about 5 years ago and arm swelled up for almost 6 months and was red; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), MANUFACTURER UNKNOWN, Lot number not reported), via an unspecified route of administration on and unspecified date in 2016 as single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient had pneumonia vaccine about 5 years ago and arm swelled up for almost 6 months and was red on an unspecified date in 2016. Patient mentioned she that never received second pneumonia vaccine. Outcome of the events was unknown.   Pfizer is a marketing authorization holder of [pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] has submitted the same report to the regulatory authorities.  Follow-up (18Oct2021): Follow-up attempts are completed. No further information is expected.