chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick as a dog; headache; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th November 2021, the patient received the 2nd dose of Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness and headache. On an unknown date, the outcome of the sickness was unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the sickness and headache to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had received the 2nd Shingles vaccine on Friday before reporting date. The patient was sick as a dog and still had a headache. The follow-up would not possible as no contact details were available.
Case number PHEH2014US015699 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 11 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 30 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
2nd morning after vaccine administered (5-2-12) nurse noted that resident had fluid filled blisters, in axilla, buttocks, knee areas. Blisters are small, pox like blisters, scattered. Patient is scratching areas.
Patient has been fully vaccinated by moderna on 4/8/21. She has tested positive and is symptomatic as of 8/11
This spontaneous report as received from a Doctor of pharmacy refers to a 61 year old female patient. On 12-SEP-2013, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # H022280, expiration date 16-JUL-2014), intramuscularly. The pharmacist reported that on 12-SEP-2013, the patient noticed that the injection site was red, swollen, painful to touch and a slight fever had developed. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
After administration of the first dose 0.5 ml Moderna vaccine patient complaint of feeling dizzy. Was offered orange juice and agreed to have it. When in about 10 sec brought orange juice to her she was unresponsive, with eyes rolled, did not respond to her name, appeared diaphoretic. Ammonia salts were administered right away, 911 called. Patient regained consciousness after 5 seconds ammonia was administered. She was alert and oriented X4 but still weak and pale. Patient was assessed by EMS. She refused to go to ER and decided to drive home by herself.
I had slight fever, terrible sore throat, bad cough. The sore throat and fever went away shortly after. My cough remains today and also have sinus drainage.
"Covid Arm" began a few hours after injection. Started at quarter sized and is now about half dollar sized. Circular itchy rash at injection site, painful upon touch. Have applied ice once or twice per day and it seems to be helping so far.
This study case was received from the investigator in a trial on 24 May 2013. A 53-year-old female subject was found to have other primary cardiomyopathies 16 days after receiving the following vaccines on 11 March 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and TYPHIM (lot number, route and site of administration not reported). Relevant laboratory data included an abnormal echocardiogram on 27 March 2013. Troponin I, ECG and MRI of the heart were unavailable. Treatments were not reported. Past medical history included high blood pressure, elevated cholesterol, chest pain, cardiomyopathy, abnormal ECG, shortness of breath and headaches. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Swelling, redness, warmth (area 25 cm x 12 cm) posterior arm 24 hr after vaccination.
Skin itchiness  all over parts of body back legs arms. Some inflammation and slight redness
Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/10 muscle pain and partial awareness to time place and location. Fatigue and pain and nauseas and weakness continued up until day 5. At day 5 8pm: loss of sensation in feet and legs, unable to ambulate, day 6: hospitalized for 7 days. Currently in inpatient acute rehab to re learn how to walk. Sharp painful neuropathy ongoing.
Pt reports she received injection at approx 3:30 pm.  At about 6:30 pm began to have chest pressure, a cough, aching, chilling, and skin itching.  At about 2:30 AM felt very bad. "Felt like I had a fever and my skin was crawling".  9/21/11 pt reports she is broke out in a hivey rash on stomach and back.
Employee/patient received the first dose of the monovalent upon hire on 8/11/22.  She did not return to the employee health clinic for the second dose.  When separate vaccine clinic opened, she received the Bivalent booster dose ahead of her second monovalent dose.
Diagnosed with Vestibular Neuronitis, Labyrinthitis, Nystagmus Severe dizziness, nausea, and vomiting on 3/15/21
devel inc fussiness, fever noc of vax;devel tremors, vomiting 24-48hrs p/vax;mom described pt as being diff to comfort w/persistent, hard cry to 48hrs post vax
Redness,hardness,and inflammation became present at right deltoid immediately after injecting vaccine. After pt sat in vehicle with medical staff present redness disappeared and knot still present. Pt not in distress or discomfort. Pt left in passenger seat with husband driving approximately 10:50AM.
While injecting, barrel detached from needle and immunization spilled out onto patient's arm.  Seemed to get about half the dose, but unsure.  Redosed 2 days later 3/17 with same lot in opposite arm as we only had 1 vial thawed/opened that day and not enough doses to give him another dose.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium
States developed a dry cough and a feeling in her chest that her valve "was sticking". approximately 24 hours after receiving the vaccine. Patient compared it to feeling like when you have blood "dragged out of your heart" she feels this in her chest -- states it's aggravated by leaning on her left side. Denies it being constant. She was advised to follow up with her PCP.
Intense Pruritis affecting the entire body.  Benadryl, steroids, or increase in Gabapentin not giving significant relief
Had first vaccine on 2020 and second November 2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose received in the year 2020).   In November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's comment: This case was reported by the patient via (Shingrix GSK) interactive digital media. The reporter had asked if that was ok. Additional supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up would not possible, as no contact, details were available.
Improper dilution of vial resulted in 15 microgram dose.  Parent notified.
5:05pm feeling tired and dizzy after vaccination and because he has hypertension said he wanted to get checked out.  EMS on scene:  BP 142/90, HR 70, T 95. 5:20pm Left observation w/out futher complaints.  Wife driving.  Advised to seek medical attention if symptoms reappear.
5 hours later: Sore left arm 12 hours later: Fever, muscle aches and weakness, chills, night sweats, fatigue 24 hours later: Fever went away but still felt fatigue 29 hours later: Lymph nodes on left side of body enflamed, specifically on the left collarbone/neck and under left armpit. Stomach ache/nausea 47 hours later (now): Same symptoms as above plus woke up with night sweats
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 4 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Patient was called about the Bivalent vaccine and will call in 2 months and recieve that one
breast pain; inflammation of the nipple; 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 BREAST PAIN (breast pain) and NIPPLE INFLAMMATION (inflammation of the nipple) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (breast pain) and NIPPLE INFLAMMATION (inflammation of the nipple). At the time of the report, BREAST PAIN (breast pain) and NIPPLE INFLAMMATION (inflammation of the nipple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Small raised itchy spots developing in random places on my skin beginning two days after the shingrix shot and still continuing as of today 2/8/2023. They are in a particular spot for only part of a day. Most of them were/are on my right side at the beginning. Now some are on my left side. Often they  are in my armpits, or on my sides.
Scabs on some lesions on the legs after 3rd shot; Red blisters get bigger after 3rd shot; Existing rash got worst after 3rd shot  and spread to both arms; Red rash on Legs, Thighs, and both arms after 3rd shot; Red blisters after 3rd shot; Some lesions itch intensely sometimes after 3rd shot; Some lesions itch intensely sometimes after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on Legs, Thighs, and both arms after 3rd shot), BLISTER (Red blisters after 3rd shot), SKIN LESION (Some lesions itch intensely sometimes after 3rd shot), PRURITUS (Some lesions itch intensely sometimes after 3rd shot) and SCAB (Scabs on some lesions on the legs after 3rd shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) 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 CELECOXIB (CELEBREX) for Rash.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on Legs, Thighs, and both arms after 3rd shot), BLISTER (Red blisters after 3rd shot), SKIN LESION (Some lesions itch intensely sometimes after 3rd shot), PRURITUS (Some lesions itch intensely sometimes after 3rd shot), ERYTHEMA (Red blisters get bigger after 3rd shot) and RASH (Existing rash got worst after 3rd shot  and spread to both arms). On 25-Aug-2021, the patient experienced SCAB (Scabs on some lesions on the legs after 3rd shot). The patient was treated with BETAMETHASONE at a dose of 0.05 % and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash on Legs, Thighs, and both arms after 3rd shot), BLISTER (Red blisters after 3rd shot), SKIN LESION (Some lesions itch intensely sometimes after 3rd shot), PRURITUS (Some lesions itch intensely sometimes after 3rd shot), SCAB (Scabs on some lesions on the legs after 3rd shot) and ERYTHEMA (Red blisters get bigger after 3rd shot) outcome was unknown and RASH (Existing rash got worst after 3rd shot  and spread to both arms) had not resolved.        The  patient also states that she is also using Sarna lotion for itching.   This case was linked to MOD-2021-296629 (Patient Link).
The second week after the administration of the vaccine my arm turned red and swell. I got nausea and intense body aches.  Iwas given antibiotics for 5 days.
Rash, 3 trunk pinpoint, 1 right neck vesicle, 1 forehead scratched, 1 left arm pustule.
Arm swollen, red and painful. affecting approx. 2/3 of upper arm
Administered expired Moderna vaccine. Vial lot number expired on 03/25/2022.
First dose: No burning, a little soreness in arm; First dose: Was just tired; had no energy and was real sleepy; had no energy and was real sleepy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 15:00 (Lot number: EN6202) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "First dose: No burning, a little soreness in arm"; FATIGUE (non-serious) with onset 05Apr2021, outcome "recovered" (Apr2021), described as "First dose: Was just tired"; SOMNOLENCE (non-serious), ASTHENIA (non-serious) all with onset 05Apr2021, outcome "recovering" and all described as "had no energy and was real sleepy".  Additional information: The patient reported no burning, a little soreness in arm after first dose Pfizer Covid Vaccine. Caller stated this began on 06Apr2021, the next day after receiving the first dose Pfizer Covid Vaccine. Caller states this went away about less than three days after it began. Caller states she recovered pretty good. Caller reports she was just tired after receiving first dose Pfizer Covid Vaccine. The patient just slept that Monday, 05Apr2021 and Tuesday, 06Apr2021, caller stayed in bed for two days. Caller had no energy and was real sleepy. Caller states this began the Monday caller received first dose Pfizer Covid Vaccine, 05Apr2021. When caller came home from receiving first dose Pfizer Covid Vaccine, caller laid in bed all day that Monday and the following Tuesday. Wednesday, 07Apr2021, caller felt somewhat better and got out and took care of some business and came back home kind of tired. Caller states she recovered from being tired. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were given. No AE(s) following prior vaccinations. Relevant tests were none.   No follow-up attempts are possible. No further information is expected.
Dishydrotic eczema palms of both hands.  Extreme burning, itching, peeling, redness, inflammation and blisters.  Treatment consists of  lotions, cortisone creams,  CBD oil ointment, etc.   Referred to dermatologist by general MD... appointment in December.  Has not resolved.
1st dodge- hives head to toe   2nd - Benadryl leading up to vaccine- hives isolated to face, belly, and back
09/28/2021 Break through case of COVID-19 and patient received an antibody infusion to help elevate the effects side effects of COVID-19. Patient is still having breathing issues and Cardiologist indicated that the breathing issue can take up to a year. Patient has history of open-heart surgery.
Really sore left arm, headache, back ache, slight chills, exhaustion - Symptoms started in the morning after the vaccine was given, and progressed into the early afternoon. I ended work early around 2:15PM and slept for 5 hours! I woke up after the first two hours of sleeping completely soaked with perspiration and dripping sweat. Took ibruprofen to mitigate the symptoms.
Headache, and mild fever at first.  At 6:00PM vomiting occurred.  Over the course of the next few days, upset stomach with diarrhea continued and the fever rose to as much as 105 degrees.  It came down with acetaminophen and/or ibuprofen but after a couple of hours would go back up.  Patient has not recovered yet.
Information has been received from licensed practical nurse referring to a 25 year old female patient who was a certified medical assistant. The patient had no concurrent condition, concomitant therapies, relevant laboratory data or medical history. On 14-APR-2017, the certified medical assistant attempted to give a dose of PROQUAD (dose unknown, once, lot# M044018, expiration date 01-MAR-2018,) and  sterile diluent (manufacturer unknown) (strength and dose unknown, once, lot# M029234, expiration date 12-MAR-2017) (Expired drug used). But it was accidentally administered to herself topically on the ocular mucous 1 time. The certified medical assistant reconstituted the medication and drew it into the syringe. When she attempted to give the injection the area between the needle and the syringe came apart and some of the medication sprayed into certified medical assistant's eye. The eye was flushed, and the certified medical assistant reported no irrigation or eye problems at this point. At the time of 14-APR-2017, the certified medical assistant was no longer accidentally administering the PROQUAD injection to her ocular mucosa and the outcome of accidental administration was unknown. Causality between PROQUAD and "the eye was flushed" was not reported. Additional information has been requested.
A few month after she just started feeling sick. As the days went on she gotta feeling sicker. Having very bad Shingles pain. Went to dr and he prescribed her pain meds.
Pregnancy due date is 12-6-2021.  Baby has bilateral clubfeet.  This is my 4th child.  No abnormalities with my precious three. Specialists do not believe this abnormaliry to be related to the vaccineas they believe it was due to a septum in my uterus but I wanted this reported.
headache; muscle pain; back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain".  Additional information: Consumer reports that after first dose she had mild to moderate symptoms like headache, muscle pain and back pain. Consumer reports that she was being administered with second dose of Pfizers vaccine on 02Apr2021. Consumer reports that after second dose of vaccine she experienced pain in the knee, fever, chills, bone pain, headache, back pain and hands pain. Consumer reports that knee pain provokes her difficulty to walk, pain in hands is so intense that she is incapable of holding or grabbing things and back pain felt like if her back was going to break.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Henoch Schonlein purpura, gastrointestinal and skin symptoms.