chrisvoncsefalvay/vaers-outcomes huggingface dataset:
different skin patches on lower legs showed up day 5 after injection; Bad muscle aches.; pain; fever; chills; swollen lymph nodes; achy eye lids; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Right arm on 05Feb2021 13:00 (at the age of 52 year old) as dose 2, single for COVID-19 immunisation. Medical history included Sjogren's, and factor V-Leiden deficient from an unknown date. Patient has known allergies to sulpha medications. Concomitant medications included apixaban (ELIQUIS); zinc; vitamin d3 and other multivitamins. The patient was not pregnant at the time of vaccination. Prior vaccination, patient was not diagnosed with COVID and did not receive any other vaccines within 4 weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in left arm, on 11Jan2021 15:00 (at the age of 52 year old), as single dose for COVID-19 immunization. After vaccination, within 16 hours of administration, that is on 06Feb2021, 05:00, patient laid flat with bad muscle aches/pain, fever/chills, swollen lymph nodes in right armpit area, achy eye lids. These lasted for 40 hours. On 10- 11th day, repetition of events occurred, almost exactly same only slightly less. On 10Feb2021 (after 5 days of injection), showed up different skin patches on lower legs. Skin patches were investigated and blood was drawn. Since the vaccination, patient had not been tested for COVID. Treatment was received for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 22 year old female working in public relations (weight 146#, height 64.5") with pertinent medical history and penicillin allergy who on 18-DEC-2006 (before Christmas) was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #654540/1151F), injection, 0.5 mL, in the right deltoid. Concomitant medication was not reported. Subsequently, on 26-DEC-2006, the patient called the physician's office and complained of redness, swelling, soreness and itching at injection site from the last week. The physician instructed the patient to ice the site locally and take BENADRYL OTC and CHLOR-TRIMETON for the itch. The patient sought unspecified medical attention. On 28-DEC-2006, the patient recovered from the events. Additional information is not expected.
big red at the injection site; swollen at the injection site; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (big red at the injection site), INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE PAIN (tenderness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (big red at the injection site), INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE PAIN (tenderness). At the time of the report, INJECTION SITE ERYTHEMA (big red at the injection site), INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE PAIN (tenderness) outcome was unknown.
1 of 6 elderly pts who devel inject site rxn of swelling,erythema. Pt has received flu vax each of the past few yr.
Extreme fatigue, sinus issues an congestion, headache, joint pain, body aches, pain at the injection site, and nausea.
throat tightness; Itching/itching of skin; This is a spontaneous report from a non-contactable other health professional. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that, "During 30 minute waiting period after the injection, the patient began to experience throat tightness and itching. Patient complained of itching of skin. Patient denied chills, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, abdominal pain, muscle aches, dizziness and headaches. Previous reactions reported that, she was brought back to bay initially for observation as she reported to pass out when she got shots. Shortly after injection, she developed symptoms above. No vagal issues arose". Treatment given was antihistamines close monitoring. Patient improving and was doing well with medication intervention. Patient has ride. Patient wheeled out to the front. Patient ambulated without difficulty. No dizziness. Instructions given on when she could take her next benadryl dose. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
As per mom noticed child's left arm red, swollen, hot and hard. Hurt to touch. Aprox 11.5 x 6 cm. Mom noticed on 11/19/2013 at around 7:00pm.
Feet started burning up to knees; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and feet started burning up to knees.  The patient's medical history included hypothyroidism, hypertension, gout and was allergic to latex. Concomitant medication included levothyroxine sodium, lovastatin, losartan and metoprolol.  On 06 Jan 2021 at 02:30 PM, approximately three hours prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number: 026L20A) on left shoulder area for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced that her feet started burning up to her knees. Treatment for the event included cherry pills.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event feet started burning up to knees was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Starting several days after receiving the second dose of the Moderna Covid-19 vaccine I developed muscle spasms on the left side of my neck which is on the same side that I received the vaccine. This does not feel like anything like I have ever had before. Multiple muscles in my left neck feel very stiff, almost like a dystonic reaction. This continues so far 1 & 1/2 weeks after vaccination.
dizziness; headache; weakness; joint pain; chills; since first dose (mild), but now following second dose is borderline debilitating; This is a spontaneous report from a contactable consumer or other non HCP (Patient) who reported for herself. A 56-years-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6199) via an unspecified route of administration on 12Mar2021 at 03:45, administered in left arm (age at the time of vaccination was 56-years-old) as a DOSE 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was E29267) via an unspecified route of administration on 19Feb2021 at 03:45, administered in left arm (age at the time of vaccination was 56-years-old) as a DOSE 1, single for COVID-19 immunization. Medical history and Concomitant medications were not reported. The patient had no other vaccine in 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The consumer reported that, I've had headache, weakness, joint pain, chills and dizziness which has remained since first dose (mild), but now following second dose is borderline debilitating. No treatment was received for adverse events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; no further information expected.
Initial unsolicited report received from nurse on 21-Dec-2017. This case involves 51-year-old female patient who was vaccinated with a dose of FLU VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on Oct 2017. The patient had a medical history of Rheumatoid Arthritis (ongoing). Concomitant medications included KEVZARA 200 mg by subcutaneous (SQ) injection, every two weeks since 09 Oct 2017 for Rheumatoid Arthritis. On 10 Dec 2017, few months following the vaccination, the patient experienced cold and flu symptoms (unspecified). On unknown date after 13 Dec 2017, post vaccination, the patient began experiencing a low WBC. It was reported that, the patient saw her doctor on 13 Dec 2017 for the cold and flu symptoms and also had follow up appointment with her doctor on 28 Dec 2017, for the low WBC. The patient thinks her cold and flu symptoms are probably related to her allergies. Lab data includes blood test. Corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patients' concurrent conditions, medical history and historical drugs were not reported. Concomitant therapy included sterile diluent. On 07-FEB-2018, the patient was vaccinated with first dose of VARIVAX lot # L048468, expiry date: L048468 (strength, frequency, route of administration were not reported) for prophylaxis (expired product administered). No adverse effects was reported. No product quality compliant was reported.
I received a call from the manager of the MD office, at 4:45 pm on July 12th, the day my son received the MMR vaccine. She informed me that patient may have received a vaccine incorrectly. She said that instead of using the proper diluent for the MMR, the person preparing the vaccine used a DTaP vaccine. She said they noticed the discrepancy when they counted their doses and diluents. There were three children who received the MMR during that time span and patient was one of them. They already called Poison Control and she informed me the results of that. The office also reported it to the health department. I also spoke with Poison Control, the health department, and the CDC and learned to watch for a local reaction. They advised close monitoring but didn't expect a significant reaction. They also informed me the vaccine needs to be repeated no sooner than a month from now as this injection is considered invalid. As of today, two days after the injection, my son seems fine. The injection site was warm for the first day, there was a small red area over a lump, and now the redness has disappeared and a lump remains. His mood and temperament is unchanged. He has not had a fever.
Underaged Immunization by 3 months and 21 days. No Adverse reaction noted.
Patient has  history of COPD, chronic alcohol and nicotine use, hyperlipidemia, recent diagnosis of ischemic stroke, sacral decubitus ulcer and left hip fracture status post surgical repair was transferred from skilled nursing facility to the Beaumont Dearborn emergency department for concern for COVID 19 infection, patient reported he has no new symptoms. Asymptomatic testing
Aching; Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN (Aching) and INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 PAIN (Aching) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PAIN (Aching) and INFLUENZA LIKE ILLNESS (Flu like symptoms) 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.   No concomitant medications were reported.  No treatment medications were reported.
Bad cold; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sponsored program. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FN6201, expiration date: 30Jun2021), intramuscularly in left arm on 20Apr2021, (at the age of 18-years-old), 1st dose, 0.3 mL single, for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. On 11May2021, the patient developed a bad cold with stuffy nose and cough. As per the reporter, it had gone through the stages as; on 11May2021, the patient had a sore throat, then on 12May2021, it was progressed to stuffy nose and on 13May2021, the patient was congested and had a cough a little bit. The patient had no fever. As of this report, the bad cold and its symptoms were ongoing. The second dose was scheduled for 13May2021. The reporter was calling to see if the patient could take the second dose on the reporting day or if they need to reschedule it. The patient did not undergo any lab tests and procedures. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
rash on upper third of left arm - started a few hours after vaccine administered and still present. Rash is red and itchy.
Large swelling and redness of left upper thigh at injection site. Mildly tender with 100 degree temp.
Had the flu shot on Friday, 10-17-14. Went to a dance that evening. Saturday evening, lost sense of taste when eating dinner. The next morning (Sunday) after waking up, ate breakfast and again had loss of taste. Noticed a bit of paralysis on the left side of face. Not severe. About an hour and a half later, since it wasn't getting better he went to the doctor who diagnosed Bell's Palsy. He was put on anti-viral med and anti-inflammatory med. The symptoms got worse before getting better. he had loss of taste, paralysis on the left side of his face, eye drooping and watering, pain behind the ear and difficulty eating and speaking. By Thanksgiving (5-6 weeks) was about 75% recovered. He has somewhat plateaued. Continues to improve and some effects remain although mostly when he is tired. He is about 85% recovered.
by 7pm she has sores all throughout her mouth and felt ill.  On 5-5-22 she went to the emergency room.  and again on 5-6-22 - they prescribed swish and spit "magic mouthwash" and valtrex.  then she went to her ENT... she was nonambulatory until 5-9-22 and she says she is still not 100%.
Rash on arm covering majority of area between shoulder and elbow, treatment with cortisone cream. Recommended Claritin 10mg daily until rash resolved.
3 inch hard, raised welt, fever and fatigue, as of 7/15/2018 no longer experiencing fatigue and fever, welt considerably smaller; no treatment wad necessary.
approx 4+ hr p/vax began w/swelling & erythema of arm & fever;swelling inc to below elbow & pt taken to ER:reflex, pedipred, motrin & DPh were prescribed by MD;swelling to upper arm was pronounced;swelling subsided in 3 days;
The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023; No adverse event; Patient received dose after its BUD date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-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. AS7171B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023).    No concomitant medications were provided. It was reported that 3 Patients received doses after its BUD date on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 1st of 3 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716134, US-MODERNATX, INC.-MOD-2023-716130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716134:case for adult patient 3 out of 3 patients US-MODERNATX, INC.-MOD-2023-716130:case for adult patient 2 out of 3 patients
This spontaneous report was received from a medical assistant referring to a 2 year old patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unspecified date in August of 2017, the patient was vaccinated with VARIVAX)(dose, frequency, route, lot# and expiration date were not provided) and M-M-R II (dose, frequency, route, lot# and expiration date were not provided), both for prophylaxis. On 21-AUG-2018, the patient was vaccinated with a second dose of VARIVAX (dose, frequency and route were not provided)  lot # R002507 expiration date 25-JAN-2020; and M-M-R II (dose, frequency and route were not provided)  lot #  N014482 expiration date 10-MAY-2020. No adverse effects were reported.
1 mon p/receiving Engerix-B tested Heptitis antigen positive;
The day after the vaccination the patient presented a rash in the superior part of the body (back, chest and abdomen).  Two days after the vaccination she presented facial paralysis on the right side.
The 2nd shot I had a little more pain fit maybe 2 days / very little pain /alittle extra soreness for a day or two.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The 2nd shot I had a little more pain fit maybe 2 days / very little pain /alittle extra soreness for a day or two.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hemorrhage and Pancreaticoduodenectomy (pancreatic surgery). Concurrent medical conditions included Cancer, Reflex sympathetic dystrophy and Nerve damage (Blood clots).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (The 2nd shot I had a little more pain fit maybe 2 days / very little pain /alittle extra soreness for a day or two.). At the time of the report, PAIN (The 2nd shot I had a little more pain fit maybe 2 days / very little pain /alittle extra soreness for a day or two.) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-060668 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow up received on 17-JUL-2021, included Patient relevant history was added. On 02-Aug-2021: Follow-up received: Non-significant information.
arm was very sore; arm was swollen; allergic reaction; could hardly get out of bed because her back pain was so bad; felt really bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (could hardly get out of bed because her back pain was so bad), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen) and HYPERSENSITIVITY (allergic reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced BACK PAIN (could hardly get out of bed because her back pain was so bad) and FEELING ABNORMAL (felt really bad). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen) and HYPERSENSITIVITY (allergic reaction). In February 2021, BACK PAIN (could hardly get out of bed because her back pain was so bad) and FEELING ABNORMAL (felt really bad) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was very sore) and PERIPHERAL SWELLING (arm was swollen) had resolved and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No specific follow-up information recorded.
Patient was given 0.5ml instead of 0.25ml patient has had no problems since vaccination and was sent a letter informed of dosage given
I woke up with hives on my chest and back.  I took pictures to  share with my doctor.  I took the Benadryl for awhile.  My doctor told me to take more of allergy medicine.  I also had Shingles during the pandemic.
Rash and hives approximately one week after shot. Improved with Benadryl and Zyrtec. Generally caused by contact.