chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 50-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The treatment information was unknown.
Can't even let anything touch that; Today I have two isolated hives; Raised; Severe reaction that day; Itchy; Red; Injection  site was hurting; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives), SWELLING (Raised), ADVERSE REACTION (Severe reaction that day) and VACCINATION SITE PRURITUS (Itchy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ETHINYLESTRADIOL, SEGESTERONE ACETATE (ANNOVERA) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ADVERSE REACTION (Severe reaction that day), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and INJECTION SITE PAIN (Injection  site was hurting). On 29-Mar-2021, the patient experienced SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives) and SWELLING (Raised). At the time of the report, SKIN SENSITISATION (Can't even let anything touch that), URTICARIA (Today I have two isolated hives), SWELLING (Raised), ADVERSE REACTION (Severe reaction that day), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and INJECTION SITE PAIN (Injection  site was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication Annovera ring  was reported.   Treatment for the itchy, injection site burning included Steroid cream.  Action taken with mRNA-1273 in response to the event was unknown
Client become sweaty and light headed approx. 15 mins after receiving HPV9, flu and Pfizer covid vaccines. Client was lowered to the floor by mom. Client was provided with cold washcloth for forehead by nurse and nurse stayed with client and mom in the lobby. Client started feeling better within approx. 3 mins and was able to sit up. Client was provided water, an apple and granola bar, per mom's consent. Client was able to consume all 3 and reported feeling better, at baseline, before leaving clinic with mom. Mom reported that client was seeing his PCP for a well child check later that day and would inform them of the event as well.
2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported; No adverse event; Received expired monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported).    Concomitant medication was not reported.  Patient received Monovalent vaccine on 13-May-2022 Lot 046L21A which was shipped on 02-MAR-2022 and thawed in a cooler while being transported. Vial did not undergo any temperature excursions.   Treatment medication was not reported.  This case is for patient 1 from 2 adult patients who received vaccine on 13-May-2022 from vial shipped in 02-Mar-2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176, US-MODERNATX, INC.-MOD-2022-682173 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow up received. Contain no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682173:Patient 2 from 2 Adult patients received Monovalent shots on 13MAY2022, master case
Day 2: soreness under right arm in arm pit  blood pressure rise, from 110/70 to 135/89 (hypertension pre-existing)
slept a lot; whole rainbow of symptoms; fever; chills; exhausted; body aches; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever) and CHILLS (chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Mar-2021, the patient experienced SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and MYALGIA (body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Events recovered in 3-4 days.   This case was linked to US-MODERNATX, INC.-MOD-2021-132183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132183:Dose 2
nausea; Fatigue/tired easily with activity; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (COMIRNATY), 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (1st booster dose, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue/tired easily with activity".  Additional information: The patient received Comirnaty second booster. Event took place after use of product. No additional history. No underlying conditions known.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills, temp of 101.8, malaise, aches and pain, pain in right arm down to fingertips. Benadryl, Loratidine daily.
Felt lots of pain in my arm at injection site. Intensified back pain! Achey ! It seemed to attack all my usual pain sites with a vengeance.  I applied ice to arm and back and neck and got some relief. It was much better in a couple of days.
Woke at 12:30 am with severe shaking and chills, Also experienced uncontrollable muscle contraction and release, repetitive movement of feet and legs, uncontrolled. Weak and dizzy,  Took Tylenol for fever, found more blankets, used breathing to try and control shaking . lasted for30-60 minutes. Live alone so do not really know how long, was shaking the king size bed with my shaking, teeth chattering, muscles contracting and releasing.
Mother noted child's eyes began shifting to the right, then back to the center. This symptom persisting to this date. Saw MD on 5/4/00 and testing is ordered. Child had no fever, no change in consciousness or any change in activity or responsiveness. Shifting occurs up to 5 times in an hour.
Pat. received H1N1 shot. 5 min later got dizzy, and vision blurred. Layed patient down and monitored BP and HR till ambulance arrived. Approximately 10 min after patient was layed down, Paramedics took vitals, all ok. Patient symptoms continued to get better, and Paramedics released her.
Delayed reaction. Circular mark at the site of the shot (hadn't shown up till now). Arm red, hot, swollen, itchy, uncomfortable.
Patient was given 4 vaccines on 2/17/09 afternoon (menactra, varivax, gardasil, adacel).  Late that evening note redness and soreness to the back of her left arm.  Mom treated with cold compress, but soreness and redness did not resolve.  Seen her on 2/19/09; teen has circumscribed area of pink inflammation to back of left upper arm.  Approximately the size of 1/2 dollar coin.  No induration or fluctuance.  This site is consistent with where varivax vaccine was given, both per record and per LPN who gave vaccine.  Due to teen's hx of eczema and cannot absolutlely r/o secondary infection, was placed on Amoxicillin.
High fever, muscle and joint severe pain, shortness of breath, fatigue, dizziness, swelling, redness
It started with a few welts - raised - same color as rest of my skin (about 3 or 4 hours after vaccine) and then started red by that night and kept getting redder and broader. By second day, there was a solid lump under the injection site as well. It started getting itchy. I saw the doctor for it but I couldn't remember the day. Benadryl was recommended for me. (I took Tylenol that night of the vaccine.) I took Benadryl for four or five days and by then it wasn't growing anymore - it wasn't getting bigger. I took one pill each time. By second week, color was starting to fade. There is no longer a lump under the injection site.
Shot administered 3/9/2021; side effects started 3/11/2021.  Patient states she had chills, muscle pain/spasms.  Mostly in her legs.  Her feet still hurt and she states her walking ability has declined.  3/14/2021 she states she has had improvement consistently, but is still feeling her walking ability is back to where it was.
RASH ON TORSO; HIVES; A SLIGHT RAISE IN BODY TEMPERATURE; NAUSEA; MILD FEVER; LETHARGY; TIREDNESS; CHILLS; MUSCLE FATIGUE; INFLAMMED JOINTS; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and other pre-existing medical conditions included the patient ha no known drug allergies. The patient was previously treated with omeprazole for acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced muscle fatigue. On 20-MAR-2021, the subject experienced inflamed joints. On 20-MAR-2021, the subject experienced lethargy. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced a slight raise in body temperature. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced mild fever. On 21-MAR-2021, the subject experienced rash on torso. On 21-MAR-2021, the subject experienced hives. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) a slight raise in temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle fatigue, inflamed joints, and tiredness on MAR-2021, and nausea, and mild fever on 20-MAR-2021, had not recovered from rash on torso, and hives, and the outcome of chills, lethargy and a slight raise in body temperature was not reported. This report was non-serious.  Version created to amend previously reported information on 23-Mar-2021. Upon review the following information was amended: Event Lethargy Labeled  Muscle fatigue labeled  Hives labeled.
Started with a fever, on day 3 fever was higher and I was short of breath as well as wheezing.  On Thursday the 15th I went to the dr. The x-ray didn't show anything however my cbc was of concern and she also did a d timer.  It came back elevated,  so she sent me over for a CAT scan with contrast. It showed pneumonia in my upper and lower right lung and also my lower left lung. She sent me home to try and treat it there. Over the weekend I felt worse and my husband took me to the ER.  Upon arrival my blood pressure was 160 over 120 and heart rate was 140. They admitted me to the hospital for treatment of sepsis and pneumonia and pain management. I was there for 4 days. I was released on the 22nd of April and I am still feeling all of these effects on my body. Headache that I have not been able to get rid of even with the help of  prescription medication.
Patient was given the Tdap and Meningitis vaccine yesterday and since 5am this morning has been vomiting and has had a bad headache.  Has been taking Advil but has not kept any of this down. The last time he vomited was 3 pm. Recommended 400mg ibuprofen and up to 650mg tylenol for HA
Her temperature was 100.6 but it was enough to keep her in bed.; Mentions with the second dose she had fever;; chills; body aches; and her arm hurt; she didn't feel well; She felt sick the day after the vaccination.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 10:00 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ulcerative Colitis", start date: 2003 (ongoing), notes: Verbatim: Ulcerative colitis; "Irritable bowel syndrome" (unspecified if ongoing), notes: Verbatim: Irritable bowel, From her late 20's. Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: 2003 (ongoing). Vaccination history included: Bnt162b2 (First Dose, Time: 09:30 to 10:00AM , Anatomical Location:left upper arm, Lot No: EN6205, Expiry:30Jun2021), administration date: 06Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious) with onset 28Mar2021, outcome "recovered" (29Mar2021), described as "Her temperature was 100.6 but it was enough to keep her in bed."; PYREXIA (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "Mentions with the second dose she had fever;"; CHILLS (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "chills"; PAIN (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "and her arm hurt"; MALAISE (non-serious) with onset 28Mar2021, outcome "recovered" (28Mar2021), described as "she didn't feel well"; ILLNESS (non-serious) with onset 28Mar2021, outcome "recovered" (29Mar2021), described as "She felt sick the day after the vaccination.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had fever, chills, body aches, and her arm hurt and she didn't feel well but all this went away within a day. She felt sick the day after the vaccination. Her temperature was 100.6 but it was enough to keep her in bed. Adds she felt better after 24 hours and the next day she was okay. The patient had no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to the emergency room or physicians office. The patient had not prior vaccination (within four weeks).  Follow-up attempts are completed. No further information is expected.
Patient reported having trouble breathing, tongue swelling, tingling sensation on lips. States having this same reaction last time she used her prescribed epi pen . Administered epi pen at 12:55. Symptoms subsided after injection given in right thigh. Paramedics called and took her to nearest hospital for further evaluation.
alternate dosing interval; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (alternate dosing interval) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051c21a and 018b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (alternate dosing interval). On 10-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (alternate dosing interval) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-437575 (Patient Link).
Evening of following day slightly feverish, next day slightly feverish, slightly nausea, slept all day.  Dizzy upon arising, fatigue.  Third day, fatigue easily, dizzy upon arising, appetite returned, nausea disappeared.  Body aches and strangely - hair hurt, actually scalp sensitive and running hand through hair was painful.  Neck ache and stiff shoulders, this lasted almost a week and a half.  No symptoms remain.
Headache, Myalgia, NauseaVomiting, inj site soreness Narrative:
About  1 1/2 hrs after vaccine became nauseated, dizzy, ringing in ears. Co-worker told her she looks pale. Maybe slight fever. No vomiting.
Narrative: 30 YO male received his second dose of the Moderna COVID-19 vaccine on 04/21/21. Pt presented to ED on 04/22/21 d/t redness in fae, sore throat, difficulty swallowing, nausea, vomiting, fever, and chills. Pt was administered diphenhydramine 50 mg IM once and dexamethasone 10 mg IM once in the ED and his symptoms resolved. Pt was sent home in stable condition with diphenhydramine 25 mg capsules, cetirizine 10 mg capsules, and triamcinolone 0.1% cream. Pt spoke with infectious disease provider on 05/21/21 and stated he was not having any further issues.
Information has been received from a mother concerning her 18 year old daughter, with a penicillin allergy and an allergic reaction to antibiotics and no other medical history, who in May 1996 at the age of 5 years old, was vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). The reporter stated that her daughter received routine pediatric vaccines along with the dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) on the same day. The mother stated that after the first dose (date not specified), her daughter "became sick." On an unspecified date, the patient was vaccinated with a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD). "Within 30 days" after the second dose the mother stated that her daughter "could not walk. She was crippled, not able to move her hands and arms. She was hospitalized for six days." The daughter is now 18 years old and experiences "flare-ups in her hips and legs every now and then." A diagnostic hip aspiration was performed (results were not provided). At the time of this report, the patient was recovering. No product quality complaint was involved. No further information is available.