chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myalgia; Not Hungry; slept a lot; thirst; tiredness; headache; chills; light fever; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst) and FATIGUE (tiredness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Heart rate variability increased since an unknown date. Concomitant products included ATORVASTATIN, METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN ACTIVE WOMAN for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-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 MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst), FATIGUE (tiredness), HEADACHE (headache), CHILLS (chills), PYREXIA (light fever) and VACCINATION SITE PAIN (vaccination site pain). On 09-May-2021, MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst), FATIGUE (tiredness), HEADACHE (headache), CHILLS (chills), PYREXIA (light fever) and VACCINATION SITE PAIN (vaccination site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: not provided (High) High Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.   This case was linked to MOD-2021-073059, MOD-2021-125294, MOD-2021-073059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: ADR: reporter info, pt info, hcp info, vaccine info, AE progress, etc.
Breakthrough case admission after 2 vaccines Pfizer 5/27/21 Lot# EW0186;  Pfizer 6/17/21 Lot# EW0191
Pt's injection site and entire upper thigh red and swollen. Pt developed welts on right side of face, several raised areas on back.
I took the shot and suffered for about a year with shingles, Suspected vaccination failure; I took the shot and suffered for about a year with shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 was unknown and the outcome of the shingles was recovered/resolved.   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 case was reported by the patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received the shingles shot and suffered for about a year with shingles.  The patient had planned not to take the shot again. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
High pulse rate of 139 bpm, cold sweats, severe fatigue/muscle aches, severe headache, dizzy.
Vaccine error occurred in office where MA was unaware of multidose vial and patient received 3 doses (1.5 mL) of Janssen vaccine. Patient was observed for 25-30 minutes without any adverse affects. Will be monitored closely with phone call next day and in office evaluation in 2 days.  No rash, swelling, or signs of allergic reaction.
10x10cm induration tense painful @ site of inj;swelling began 10 days p/vax;no fever;mild pale pink color skin;delayed hypersensitivity;hosp for abscess @ inj site;
Dose 1 04/22/2021 Lot # EW0172 Pfizer   Pt died on 9/30/2021 in the ED from complications with her end stage adenocarcinoma. This was not a Covid illness related death
Pt came in the morning on 10/30/17 complaining of upper right arm soreness, said he got the flu shot in 10/11/17 and has been really sore and is unable to move his right arm above his head. Contacted his Primary care MD Dr 10:48am.
Systemic: Death. Unknow cause as of reporting date. -Severe, Additional Details: PT caregiver called to report that the Pt passed away on 3/8/21 2 days post vaccince, Caregiver was distrot and not very able to provided more details due to reccent nature of report.
Severe headaches; Tired; Muscle and joint pain; Muscle and joint pain; Nausea; Stomach pain; Fever; Chills; was really tired/had muscle and joint pain/nausea/Stomach pain was reported as worsened/it is probably the worst her fibromyalgia has been in several years; Cellulitis that she had return on her leg so she wasn't sure if that was related to the Pfizer COVID Vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 70 year old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0172)(At the age of 70-years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from 2001 and ongoing  diagnosed over 20 years ago, fibromyalgia from 2011 and ongoing diagnosed over 10 years ago. The patient's concomitant medications were not reported. The patient who has received both doses of the Pfizer-BioNTech Covid19 vaccine, with her second dose being administered on 18May2021 Batch/Lot Number: EW0182). After her first dose, she experienced, "severe headaches, was really tired, muscle and joint pain, nausea, and stomach pain".  She notes that her symptoms "amped up" after the second dose.  She reports that she is still experiencing headaches (>1 month after vaccination) but they have "lessened in intensity" and reports, "in the beginning, her hair hurt to touch". She has a history of fibromyalgia and would like to know if this is contributing to her intensity and duration of symptoms. The patient experienced cellulitis that she had return on her leg so she wasn't sure if that was related to the pfizer covid vaccine on 2021,On 28Apr2021 Patient experienced severe headaches,  tiredness, muscle and joint pain , nausea , stomach pain , fever , chills , was really tired and had muscle and joint pain with nausea and stomach pain was reported as worsened/it is probably the worst her fibromyalgia has been in several years leading to condition aggravated on 28Apr2021 . Patient stated that after the reported symptoms she did follow up with her family physician and that was part of the reason for seeing her physician but she also saw the HCP for cellulitis that she had return on her leg so she wasn't sure if that was related to the Pfizer COVID Vaccine; states the cellulitis returned and probably started out as a red area so she would say the cellulitis returned maybe a week or two after the 1st dose of the vaccine and she had been treated for the cellulitis earlier in the year and started to see it in the same location which was a redness in the area and then it began to grow in size .Therapeutic measures were taken as a result of cellulitis with Cephalexin 500mg capsules by mouth and it was four times per day and filled on 16Jun2021 .The outcome of events fever and chills were recovered on unknown date in Apr2021and all other events were not recovered .  Upon Follow up (15Jul2021): additional information about lot number and patient details with adverse events were added   Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
pt recv vax 15AUG97 & exp loss of all hair on the scalp, as well as the loss of eyebrows & longer eyelashes;
chills - only the night of vaccine headache, fatigue - started 2/20/21 and lasted 2 days stiff sore arm, large knot just below injection site, site very hot to touch - started 2/20/21 and lasted for 3 days
mom reports day of vax 8/13/99 child stopped smiling, interacting;8/21/99 mom noted episode wehre eyes roll back, upper extremities jerk & chest lunges forward for 1min;
very mild pain, as if poked hard in the arm; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and vertigo. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, on the first day of vaccination, the patient did not feel the injection and had no side-effects. On an unknown date in 2021, day 2 (within 24 hours) of vaccination, the patient experienced very mild pain, as if poked hard in the arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event very mild pain in the arm was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
upper part of deltoid got red; very hot to touch; a little bit swollen; injection site swelling; itching; little bit of redness; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of LIGAMENT SPRAIN (upper part of deltoid got red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (little bit of redness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN, AMLODIPINE, PANTOPRAZOLE, MULTIVITAMIN MULTIMINERAL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (little bit of redness). On 15-Jan-2021, the patient experienced LIGAMENT SPRAIN (upper part of deltoid got red), VACCINATION SITE WARMTH (very hot to touch) and VACCINATION SITE SWELLING (a little bit swollen). On 11-Jan-2021, VACCINATION SITE PRURITUS (itching) was resolving. At the time of the report, LIGAMENT SPRAIN (upper part of deltoid got red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (little bit of redness) and VACCINATION SITE SWELLING (a little bit swollen) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Febrile convulsion within 24 hrs after DTAP shot. Temperature 104.
PT. REC'D #2 HPV 11-9-07 L DELTOID IM. NO SWELLING REDNESS, OR OTHER REACTION NOTED. THEN ON 11-28-07 STARTED HAVING L DELTOID SWELLING & PAIN. WAS SEEN IN CLINIC 11-29-07, NOTED TO HAVE 1 1/2 - 2 CM HARDENED AREA L DELTOID TENDER TO TOUCH
2DEC93 pt had cried hard, rolled eyes back, gasped for breath; mom to contact MD immed; pt hospitalized;
PT CALLED 4/6/19 6:30p TO REPORT "A PAINFUL RED SPOT THE SIZE OF A PIECE OF BREAD" AT THE SITE OF INJECTION OF HER SHINGRIX AND PNEUMOVAX 23 SHE RECEIVED 4/4/19. NO FEVER. PT USED ARM EXTENSIVELY YESTERDAY (WASHED WINDOWS). ADVISED HER TO DRAW A DOTTED OUTLINE OF THE REDNESS WITH A PEN TO MONITOR SIZE. ADVISED TO GIVE IT 1-2 DAYS. IF NO IMPROVEMENT, SEE A PHYSICIAN FOR POSSIBLE CELLULITIS. OFFERED TO CALL TO CHECK ON PATIENT 4/7, HOWEVER PATIENT "DID NOT WANT TO RUIN MY SUNDAY." SHE SAID SHE WILL CALL US 4/7 IF ANY PROBLEMS. OTHERWISE, WILL CALL HER MONDAY TO CHECK ON HER.
Patient felt dizzy after vaccine administration. Reports this happens to her often with blood draws. Patient given ice pack for forehead and cold water, she reclined in chair for approximately 10 mins. No loss of consciousness. Vital signs checked WNL and patient feeling back to normal.  Disposition home
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 88.75. No concomitant medications were reported.  It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 03-Nov-2021, Excursion time was 10 AM, temp was 35, total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vial was moved to clinic. Vaccine BUD date was 05-Nov-2021.  Vials only punctured right before administration.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
2hr p/vax the site became very itchy & red & began to fell nauseated & lightheaded;pt very anxious ;pt slept;
Symptoms: hives, swelling of the face and throat. Difficulty breathing, fast heartbeat, weakness, no feelings in feet and hands, fatigue, fever, muscle aches, headache, nausea, shot area-swelling and redness at site of injection.
very itchy left arm; symptoms appeared again, i have swollen, red arm; symptoms appeared again, i have swollen, red arm; Hurted really really bad; Swollen left arm; Red left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE PAIN (Hurted really really bad), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE ERYTHEMA (Red left arm) and VACCINATION SITE SWELLING (symptoms appeared again, i have swollen, red arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O32L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Hurted really really bad), VACCINATION SITE SWELLING (Swollen left arm) and VACCINATION SITE ERYTHEMA (Red left arm). On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE SWELLING (symptoms appeared again, i have swollen, red arm) and VACCINATION SITE ERYTHEMA (symptoms appeared again, i have swollen, red arm). On 25-Jan-2021, VACCINATION SITE PAIN (Hurted really really bad), VACCINATION SITE SWELLING (Swollen left arm) and VACCINATION SITE ERYTHEMA (Red left arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (very itchy left arm), VACCINATION SITE SWELLING (symptoms appeared again, i have swollen, red arm) and VACCINATION SITE ERYTHEMA (symptoms appeared again, i have swollen, red arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included Thyroid medication for unknown indication.  The patient not taking any medication as a corrective treatment.  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.   Reporter did not allow further contact; 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.
Pt has a PMH of COPD and presented to the ER with shortness of breath.  Prior to intubation, patient denied fevers, chills, or productive cough.  Pt is not on home oxygen.  Pt was admitted for acute hypercarbic hypoxic respiratory failure, COPD exacerbation, COVID-19 positivity, and NSTEMI.
Woke up to rapid heartbeat and pulsatile tinnitus at 3:30 a.m. (day after injection). Had an elevated blood pressure at 9 a.m. (I have normal blood pressure.) Played tennis at 10:30 a.m. until 12:30 p.m. and felt fine. Still had rapid heartbeat that evening. By next morning I was back to normal.
severe L axillary swelling such that couldn't rest arm at side.  swelling has now improved but not resolved, still with some L axillary, chest wall pain, and some pain radiating down ulnar side of arm. L upper outer quadrant breast tenderness and swelling
Treatment of COVID-19; Treatment of COVID-19; Rebound 5 days after treatment and return to test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac issues. Took 1/2 dosing" (unspecified if ongoing), notes: Cardiac issues. Took 1/2 dosing. The patient's concomitant medications were not reported. Past drug history included: O, reaction(s): "known allergies: O". The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "Rebound 5 days after treatment and return to test positive"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: COVID 19 Treatment from 11Aug2022 to 11Aug2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Event: Rebound 5 days after treatment and return to test positive, adverse event start date: 24Aug2022, adverse event start time: 06:00 AM. Patient recovered. No treatment ae.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had Pfizer vaccination around 1:30pm . On drive back to work she started feeling "foggy". around 3:00pm and started to get a headache and blurred vision. Patient stated never feeling this way in past. She then began to feel like she was going to pass out. Still had blurred vision and headache. Recommended she go to the ER since she felt like she was going to pass out each time she tried to stand. Patient wen to the ER at 4pm. Patient received shot in the Left arm
On the morning of day 8 post-vaccine, I developed what is coming to be known as ?Covid Arm?.  Symptoms consisted of a red, raised rash; swelling in the arm; slight soreness; itching; warmth to the touch.
On the night of 01/23/2023, around 10:00PM, my son suddenly vomited. Over the course of the next five hours, he vomited a few more times for a total of four instances. The morning of 01/24/2023, we measured a fever of around 102 degrees Fahrenheit. Over the course of the following six days, through 01/30/2023, we took his temperature regularly and it was around 101 and 103 degrees. We alternated ibuprofen and acetaminophen which controlled the fever. The only other symptoms he experienced during this time were lethargy and lack of appetite. On 01/31/2023, we took him to a local urgent care clinic. That morning, his temperature was normal, but the doctor explained that he had an ear infection in his right ear. She prescribed amoxicillin which we began that night. On 02/01/2023, we flew home and continued his treatment for seven days. On Tuesday, 02/07/2023, we went to his pediatrician who confirmed that the ear infection had cleared up. Other members of the family and close contacts did develop colds both before and after these events. They experienced fever and coughs.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.   The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5/9. Patient does not plan to get revaccinated at this time.