chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; it makes me a little tired; dizziness; diarrhea; second dose greater than 36 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (it makes me a little tired), DIZZINESS (dizziness), DIARRHOEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip replacement. Concurrent medical conditions included Glaucoma (In the left eye), Blood pressure high and Drug allergy (codeine). Concomitant products included DORZOLAMIDE, LATANOPROST and LORATADINE for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose). On 28-Jan-2022, the patient experienced HEADACHE (headache), FATIGUE (it makes me a little tired), DIZZINESS (dizziness) and DIARRHOEA (diarrhea). At the time of the report, HEADACHE (headache) and DIZZINESS (dizziness) had not resolved and FATIGUE (it makes me a little tired), DIARRHOEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose) outcome was unknown.            Patient stated that the headache still comes and goes and still has a little dizziness.  The patient denied taking any medications for her symptoms.   This case was linked to MOD-2022-476120 (Patient Link).
Sore arm initially. After 12-15 hours, developed dizziness, nausea, muscle aches, drop in blood pressure to 57/43 (BP returned to normal within an hour with hydration and putting feet up). Muscle aches and chills followed, peaking at 20-hour point. Relieved by ibuprofen and a nap. Recovered and nearly back to normal 24 hours after injection. Minor arm soreness on day 2 but not bothersome; able to perform normal activities.
Auto immune response; Joint pain/Pain in shoulders; neck pain; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received for the tolerance of the 1st dose, refer linked case US2022AMR130563).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant), joint pain and neck pain. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the autoimmune disorder, joint pain and neck pain were not recovered/not resolved.   The reporter considered the autoimmune disorder, joint pain and neck pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR130563   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received second dose of Shingles vaccine. The reporter stated that after received Shingles vaccine the patient experienced pain in every joint in body, pain in neck and pain in shoulder. The reporter stated that it was took several months to determine that the vaccine had give patient an auto immune response. The patient received Steroid as treatment, steroid relieve the pain but as long as patient continue to use. Patient told that this was only happen to one in a million people. The reporter stated that the patient was off the steroid but still had the pain in neck and shoulder. Patient told to everyone that if you had strange symptoms after first dose please does not receive the second dose. Follow-up would not possible as no contact details were available. Additional supportive information: For the tolerance of the 1st dose, refer linked case US2022AMR130563, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR130563:Same reporter
Patient received vaccine on Saturday morning. On Sunday morning, he experienced chest tightness that resolved with no treatment. On Monday evening, he fainted walking to the bathroom. Wife states that patient regained consciousness within a few seconds.  EMS was called and arrived about 2 minutes after the episode. Wife reports all vitals and EKG were normal when paramedics checked patient out.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. 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 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started from 02Oct2023 to 06Oct2023..; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328745 same reporter/patient, different product/AE;
The mother states the child was crying around 2 am on 11/10/00. She placed him in his bed and found him unresponsive and not breathing at 6:00 am. Child was pronounced DOA. Autopsy states sudden infant death syndrome. Also shows pulmonary congetsion, liver congestion
Mastitis in size of "egg" and "hot"; Lipoma; turned to brown like sun burn; Received antibiotics and she had harsh reaction to it; Itchy arm; "ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"; This spontaneous case was reported by a consumer and describes the occurrence of MASTITIS (Mastitis in size of "egg" and "hot") in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to Celebrex), Drug allergy (Allergy to Codeine), Allergy to antibiotic (Allergy to Erythromycin), Drug allergy (Allergy to Viax), Allergy to antibiotic (Allergy to Cefoxitin), Drug allergy (Allergy to Valdecoxib) and Infection. Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR), VALSARTAN (DIOVAN), HYDROCHLOROTHIAZIDE, METFORMIN, TRIAMCINOLONE and AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVUNATE POTASSIUM) for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-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 experienced MASTITIS (Mastitis in size of "egg" and "hot") (seriousness criterion medically significant), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn"). At the time of the report, MASTITIS (Mastitis in size of "egg" and "hot"), LIPOMA (Lipoma), SKIN DISCOLOURATION (turned to brown like sun burn), ADVERSE DRUG REACTION (Received antibiotics and she had harsh reaction to it), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA ("ed and itchy little dots" at the site of the injection which also relocated on her arm and turned to brown like "sun burn") outcome was unknown.            No relevant concomitant medications were reported. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.   This case was linked to MOD-2021-214864 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
TDaP not recommended to be given before seven years of age or as the 5th dose in the initial DTaP series. No complaints from the patient. No signs and symptoms of an adverse reaction.
Dizziness, nausea, disorientation onset 10-15 min after vaccine - informed official at vaccination site & monitored me (took blood pressure, heart rate, listened to lungs)   Symptoms became worse 30 minutes after vaccine - severe nausea and dizziness, very disoriented, feverish, throat started to swell - nurse had me lay in a comfortable reclining chair, put a fan on me and continued to monitor/take vitals   Called the paramedics due to throat swelling becoming worse   Paramedics assessed me again, vitals were normal, but took me to the hospital to be checked further   Received 25mg of Benadryl once admitted to emergency - PA assessed me and gave me 3 prednisone to stop and further reaction   Prescribed the Benadryl and prednisone , was discharged
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.38. Concomitant products were not provided. On 27-Feb-2021, Excursion time was 09 AM,11 AM,12 PM,1 PM,2 PM,3 PM, 4 PM and 5 PM, temperature were 33,35,35,35,35,34,34 and 35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 PM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35. On 27-Mar-2021, Excursion time was 09 AM,10 AM, temperature were 35 and 35, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
thinks he has COVID 19 now; Fever; Headache; muscle aches; Chills; Sore throat; Runny nose; Upset stomach; This is a spontaneous report from a contactable consumer. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 16Mar2021 (at the age of 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient had no medical history. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. The patient experienced thinks he has covid 19 now on an unspecified date. On 19Mar2021, he started to have a fever, headache, muscle aches, chills, sore throat, runny nose and an upset stomach that are still persisting today. The patient experienced thinks he has covid 19 now on an unspecified date, Adds the patient is really concerned, and thinks he has COVID 19 now. He even went so far as to get an appointment for the test. It was reported that he got the first dose of the Pfizer COVID 19 vaccine on Tuesday 16MAR2021 at unknown time in an unknown arm. Caller added they were wondered with all of these symptoms should he get a COVID 19 test as suggested to call Pfizer. Patient had not visited physician office. Time the vaccination was given was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The outcome of thinks he has covid was unknown and other events were not recovered.
This spontaneous report as received from a healthcare worker refers to a 29 years old patient (gender unknown). On 13-MAY-2014, the patient was vaccinated with GARDASIL injection, 0.5 ml (milliliter), intramuscularly. No concomitants were reported. The healthcare worker reported that a patient was accidentally administered GARDASIL instead of TDAP. No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of was unknown. No further information was provided. Additional information has been requested.
Difficulty to lift right arm; Stiffness in right arm; Pain in right arm; This is a spontaneous case, initially received from other health professional (pharmacist) via Med Communications (reference number: SEQ20-00692) on 19-Feb-2020, concerning a 71-year-old, female patient.   The patient's medical history included that the patient received unspecified flu vaccine, Prevnar 13 (pneumococcal 13v conjugate vaccine) and Zostavax (varicella zoster vaccine live) in 2018 and no adverse events were reported after vaccines.  The patient's concomitant medications were not provided.   On 12-May-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, route of administration: intramuscularly (IM), anatomical location: left arm (LA), batch number: P100112490, expiry date: 11-Jun-2020 and dose: not reported) for unknown indication.  On the same day, the patient was administered Pneumovax 23 [pneumococcal vaccine polysacch 23v, route of administration: intramuscularly (IM), anatomical location: right arm (RA), batch number: R034248, expiry date and dose: not reported) to complete the pneumonia series recommendation.  On the same day, the patient experienced pain and stiffness in her arm. Patient was advised to use ice and take ibuprofen for the pain.   On unspecified date, the patient's pain subsided, but the arm was stiff, and it was difficult to move arm, two months later.   On unspecified day in Feb-2020, the patient visited physician who ordered physical therapy.  On 19-Feb-2020, the physician stated pain and stiffness were in the right arm.  On unspecified date, the outcome of event 'pain in arm' was resolved.  At the time of this report, the outcome of events 'stiffness' and 'mobility decreased' was not resolved.  The reporter did not provide the causality assessment to Afluria Quadrivalent.  Company comment: The patient experienced mobility decreased, musculoskeletal stiffness and pain in extremity after vaccination with the suspect product, Afluria Quadrivalent given in the left arm. Chronology is plausible. Non-company co-suspect vaccine Pneumovax 23 (pneumococcal vaccine polysacch 23v) was given in the right arm and on that arm, events appeared. Since these were localised events, causality between suspect product and the events is assessed as not related.; Sender's Comments: The patient experienced mobility decreased, musculoskeletal stiffness and pain in extremity after vaccination with the suspect product, Afluria Quadrivalent given in the left arm. Chronology is plausible. Non-company co-suspect vaccine Pneumovax 23 (pneumococcal vaccine polysacch 23v) was given in the right arm and on that arm, events appeared. Since these were localised events, causality between suspect product and the events is assessed as not related.
allergies have been way out of control; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (allergies have been way out of control) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (allergies have been way out of control). At the time of the report, CONDITION AGGRAVATED (allergies have been way out of control) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided. patient had allergies is of  entire life. Since patient received  first Moderna COVID shot,  allergies  of the patient have been way out of control.   Reporter did not allow further contact
Shortness of breath x 12hrs, chest pain x 5-6 hrs.  Transferred to Hospital where he was asymptomatic.  Troponin peaked at 12 with EKG changes suggestive of pericarditis.  Diagnosed with myopericarditis likely secondary to smallpox vaccine.  Admitted to ICU, then evacuated to another hospital the following morning on first available flight.
pt recv vax 3MAR95 & devel t101-temp varied w/reading of 102.9-105-102; pt given APAP; pt was sleeping when let out 2 screams & was found convulsing x 30-45sec; later pt was rigid; taken to ER-t106 6MAR had ear infect & was adm to hosp
Concern - left side facial paralysis  Onset: 3/26/21 - pt received first COVID vaccine (moderna) into the left arm; pt  is concerned about bell's palsy Description: left side facial paralysis/pain, left ear pain - pt says things sound different/louder   Intensity: mild Progression of Symptoms:  worsening Accompanying Signs & Symptoms: trouble talking, minor trouble swallowing/eating Previous history of similar problem: none Precipitating factors:       Worsened by: lying down on left side Alleviating factors:       Improved by: none Therapies tried and outcome: aspirin, heat packs - not helpful This previously healthy 60-year-old female presents to the clinic to be evaluated for left facial drooping and numbness sensation that started after she received her first Covid vaccine on 3/26/2021.  She denies any weakness in her upper or lower extremities.  She is not feeling ill or having fevers.  She is unable to blink the left eye and the left side of her mouth droops downward. Symptoms are consistent with left sided Bell's palsy.  There are some reports of this occurring after the Moderna Covid vaccine, but not clear causal evidence at this time.  She was given a prescription for prednisone and I am contacting MDH to file a report.  I recommended against starting an antiviral
chills; body aches; headache all day; Feeling very tired; A spontaneous  report  was received from a  consumer concerning an male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced Head ache, chills, fatigue, body aches.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications were not reported.  On Un known date the patient received their   second   of two planned doses of mRNA-1273 (lot number  Unknown)  for prophylaxis of COVID-19 infection.  On Unknown date  the patient experienced  events chills, body aches, head ache and fatigue.   Treatment information  provided was Advil and Dayquil.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events   Head ache and chills were Resolved. and Fatigue and body aches were not Resolved.
I contracted COVID-19 with symptoms of body aches, sore throat, cough, congestion, headache, and fever of 101. I was prescribed PAXLOVID, and BREO ELLIPTA inhaler, albuterol inhaler, and benzonatate on 10/17/22. I was ill for 4 days before my symptoms began to improve. My cough lingered until 10/31/22. I am now fully recovered with no lingering symptoms.
Soreness at injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955), via an unspecified route of administration in left arm on 23Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications received within two weeks of vaccination included multivitamin (MANUFACTURER UNKNOWN), vitamin d supplement (MANUFACTURER UNKNOWN), docosahexaenoic acid (DHA) (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN) from an unknown date for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had not tested for COVID-19 since the vaccination. On 24Mar2021, the patient experienced soreness at injection site and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site pain and fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1.Patient initials updated as UNKNOWN.
On 10/07 in morning, red, hot, swollen, and sore and nausea. Pt took BENADRYL Sunday. Temp 101.6 F on Sat, no temp now.
Pt. reports pain in rt. leg from time vaccine was administered to present. Pt. reports feeling a sensation "like lightening" going down her leg when she received her pneumonia vaccine. Pt. states the injection was administered with great speed and pt. suspects nerve involvement. Pt gets relief with ALEVE. Pain increases with activity.