chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On around March 29th 2021 I woke to find my clavicle lymph node on my right side swollen. Since that time, both clavicle lymph nodes on both sides are swollen, some days worse than others, but neither have gone down. The right side is the worst and it has been painful and sometimes feels nimb around the area. At times it feels like the right side of my neck and jaw is also swollen. I need to know that I can get the second dose on April 17th without worrying it's going to kill me.
Arm went into spasm, like it hit a nerve; Shooting pain up left side of face into temple; Pain going down jaw into her neck left side; Pain going down jaw into her neck left side; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arm went into spasm, like it hit a nerve), FACIAL PAIN (Shooting pain up left side of face into temple), PAIN IN JAW (Pain going down jaw into her neck left side), NECK PAIN (Pain going down jaw into her neck left side) and PAIN IN EXTREMITY (Pain in the arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MUSCLE SPASMS (Arm went into spasm, like it hit a nerve), FACIAL PAIN (Shooting pain up left side of face into temple), PAIN IN JAW (Pain going down jaw into her neck left side), NECK PAIN (Pain going down jaw into her neck left side) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, MUSCLE SPASMS (Arm went into spasm, like it hit a nerve), FACIAL PAIN (Shooting pain up left side of face into temple), PAIN IN JAW (Pain going down jaw into her neck left side), NECK PAIN (Pain going down jaw into her neck left side) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown.            Nurse told her to alternate between taking ibuprofen and Tylenol daily.  No concomitant medications reported.   This case was linked to MOD-2021-393216 (Patient Link).
Bad reaction after the first dose / Fever; Bad reaction after the first dose / Flu like reactions; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2019, the patient received Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The patient reporter for herself. The age at vaccination was not reported. The patient experienced fever and flu like reactions after having 1st dose of Shingles. The patient had 2nd dose of vaccination in February 2020 The patient consented to follow up.
Throat tightness; Scratchy throat; A spontaneous report was received from a consumer concerning a 35-year-old, female patient who experienced throat tightness and scratchy throat.   The patient's medical history, as provided by the reporter, included allergies to the flu shot and  food allergies of wheat, corn, and citrus.  No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 05 Jan 2021, During her 15-minute waiting period after the injection, the patient began to experience throat tightness and scratchy throat. The patient was assisted in the emergency bay area and monitored for severe reaction symptoms.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, throat tightness and throat irritation was unknown.; Reporter'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.
On Wednesday, March 24, 2021 patient received her first dose of Pfizer COVID vaccine (LOT # ER2613, EXP 7/2021) at approximately 12:05pm. Patient has a history of Penicillin allergy and was to be observed for 30 minutes after administration of her vaccination. While in Observation Area, patient reported she felt a sensation of her "throat swelling" at 12:10pm and vitals were taken by EMTs. Vitals at 12:10pm: HR: 128bpm, 02 sat: 98%. Lead PHN was alerted and upon observation authorized EMT to administer 50mg of Diphenhydramine HCL oral solution per protocol with a water bottle at 12:15pm. BP at 12:16pm: 132/84. At 12:25pm, vitals were taken again shortly after and pulse returned to within normal limits, 94bpm, O2 sat: 99%. At 12:30pm: BP 140/78. At 12:40pm, patient reported the swelling in her throat had completely subsided. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Patient was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Patient left vaccination site with a steady gait.
Pfizer 2/3/21, 3/17/21, 11/18/21. Positive on 7/19/22
3/4 vaccine; 3/5 arm swelling redness dx "cellulitis" urgent care KEFLEX; 3/6 flushed cheeks arm swelling dx "vaccine reation" DC KEFLEX.
CHILD PRESENTED TO ER WITH COMPLAINTS OF REDNESS AND SWELLING OF BILAT THIGHS POST INJECTION.  CHILD EXTREMELY FUSSY. REFUSED TO ALLOW STAFF TO TOUCH L. KNEE.   R. THIGH HAS SOFTBALL SIZE ERYTHEMA L. THIGH TO KNEE IS ERYTHEMOUS AND SWELLING AROUND MEDIAL TENDON.  TENDER TO PALPATION
tested positive for covid after 2 doses of Moderna vaccine; loss of taste; sore throat; headache; moderate to severe muscle aching; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching). At the time of the report, COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Patient got her doses of Moderna COVID-19 vaccine in March 2021. Patient had the booster shot of Moderna after having had COVID.  Company comment: This case concerns a 68-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI events of Covid-19 and ageusia, 5 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had moderate Covid, but did not require hospitalization. Patient had headache, loss of taste, sore throat, and moderate to severe muscle aching. She had the booster dose after having Covid. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI events of Covid-19 and ageusia, 5 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had moderate Covid, but did not require hospitalization. Patient had headache, loss of taste, sore throat, and moderate to severe muscle aching. She had the booster dose after having Covid. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Body warmth; left side of head "felt strange"; has "red blotches" on her face , left arm , and knees; injection site redness for 4 days; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 28th October 2020, unknown after receiving Shingrix, the patient experienced head discomfort and red blotches. On an unknown date, the patient experienced injection site erythema and feeling of warmth. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the head discomfort, red blotches and feeling of warmth were unknown.   It was unknown if the reporter considered the injection site erythema, head discomfort, red blotches and feeling of warmth to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced red injection site, red blotches on her face, left arm and knees and her left side face felt strange after receiving the dose of Shingrix. No additional details were provided. The reporter did not consent to follow up.
Chills  Fever Fatigue Joint pain Injection site pain  Lightheadedness
Information has been received from a nursing supervisor concerning a female (age not reported) who on an unspecified date was vaccinated with HPV. Subsequently, the patient reported that her "arm felt dead". At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information confirmed that the patient had recovered on approximately 05-Nov-2007 ("next day") and felt fine. On 07-Feb-2007, the patient was vaccinated with the second dose of GARDASIL, and "was fine." Additional information is not expected.
Patient was administer 0.3 mL of undiluted Pfizer Vaccine.  Pt offered MD exam to include EKG and troponin levels with follow up,  Pt complains of severe myalgias and headache first day.
patient had loss of vision and dizziness for two days starting day after the vaccine. patient states that symptoms have improved but vision is still impaired slightly.
1st two days: severe pain in arm, severe headache, fatigue, chills Day 3 and Day 4: moderate pain in arm upon touching or moving, welps, swelling, bruising around injection site
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 28-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Patient received DPT, HIB, Hep B, Prevnar. That afternoon, had seizure and temp documented at 105.7. ER work up documented no other source.
Anaphylaxis: Symptoms began 35 minutes after vaccine administration. Because I have a history of Anaphylaxis (to Iodonated Contrast & Seafood) they watched me for 30 minutes & I was fine. Walking to my car, I started to have itching on my face, so the reaction started 35 minutes post vaccine.  It progressed, eventually developing into severe sneezing, itching of face/ neck/chest/scalp & back of throat - with that, I called the Allergy/Immunology Clinic. I had taken Loratadine when it started. The on call fellow had me take Benadryl which I also had with me (in my Anaphylaxis Kit)... that was probably 1 hr post vaccine. Approximately 1 hr later the Dr called me. I had developed lip tingling so she had me take more Benadryl & I believe additional Prednisone (beyond my daily dose). I also had nausea but no vomiting.  I was told the next day to take a tapering dose of Zyrtec for 5 days.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 9-weeks-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 30-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Approximately 12 hours after the shot I developed symptoms including, brain fog, chills, aches, and pain at the sight of the injection. Over the course of the night, I fell more ill and finally took my temperature in the morning around 7 AM and had a fever of around 100.4 F. I took Tylenol about every 6 hours for the next 24 hours with my temperature fluctuating between normal and 100.4 F. During this time, I was too ill to do anything more than sleep or lay in bed. The following day, my temperature broke, but I was still experiencing aches, chills, and brain fog, along with the pain at the injection site. After about 84 hours from the time of the vaccination, I felt normal enough to resume my daily activities.
This spontaneous report as received from a registered nurse to a 13 year old female patient. On 20-JUN-2014 the patient was vaccinated with a fourth dose of RECOMBIVAX HB (5/0.5 mcrg/ml, 0.5ml, intramuscular) in place of VAQTA. No adverse effect was reported. Additional information has been requested.
Fever starting 15 hours after vaccination and continuing for three weeks and still having fever to 102
Patient Pfizer covid-19 vaccine was administered in the left arm around 438pm. The patient eyes rolled back and then the patient passed out. 911 was called. She then awoke after a few. The paramedics arrived and examined and took vitals on the patient. Mom decided not to send her daughter with the paramedics. Patient was still a little disoriented however, she was able to walk out of the facility.
The pharmacist administered the Pfizer vaccine to a patient using an Easypoint needle.  After administering the vaccine the safety mechanism was activated.  As the needle was retracting into the syringe, some liquid splashed into the pharmacist's eye.
Information has been received from the mother of a 13 year old female who on 17-NOV-2006 was vaccinated with her second dose of Gardasil.  There was no concomitant medication.  It was reported that starting in January 2007, the patient had not menstruated.  Additional information has been requested.
Vaccination was given late afternoon. Typical reaction of site tenderness later that evening. By the next morning his arm was more tender. In the following days there has been pain radiating from the injection site upwards towards the base of the skull across his shoulder. Mild headache. Pain radiating down his right arm to the little finger and ring finger on the right hand.  He has also had extreme fatigue. Heat has not relieved or eased the pain. Wednesday evening, August 25, the pain level had worsened to his not being able to lift his arm. His hand curled into a clawlike form.  NOTE: INR at time of injection was 4.7...goal is 3.5-4.
suspected vaccination failure; Round 1 was 3 years after the shingles vaccine/shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years 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 consumer for herself/himself. The age at vaccination was not reported. The patient experienced 1st round of shingles 3 years after the Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. For the tolerance of the 2nd round of shingles, refer linked case US2021AMR211140, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR211140:same reporter
headache; nausea; Extremely light headed; fatigued; Felt bedridden for 24 hours; weakness; chills; Body aches; Ankle pain; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), BEDRIDDEN (Felt bedridden for 24 hours), DIZZINESS (Extremely light headed), RASH (Rash) and ARTHRALGIA (Ankle pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylerol, Codiene). Concomitant products included LORATADINE (LORTADINE) for Allergy to animal, PARACETAMOL (TYLENOL) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced RASH (Rash). On 17-Feb-2021, the patient experienced ASTHENIA (weakness), ARTHRALGIA (Ankle pain), CHILLS (chills) and MYALGIA (Body aches). On 18-Feb-2021, the patient experienced BEDRIDDEN (Felt bedridden for 24 hours). On 21-Feb-2021, the patient experienced DIZZINESS (Extremely light headed) and FATIGUE (fatigued). On 22-Feb-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness), BEDRIDDEN (Felt bedridden for 24 hours), DIZZINESS (Extremely light headed), ARTHRALGIA (Ankle pain), FATIGUE (fatigued), HEADACHE (headache) and NAUSEA (nausea) was resolving and RASH (Rash), CHILLS (chills) and MYALGIA (Body aches) had resolved.            Treatment medication was Tylenol. Concomitant product use include Loratidine for the treatment of Cat allergy   This case was linked to MOD-2021-019906 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-4-2021, patient information added, allergy added, concomitant product use added and events added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the event, a causal relationship cannot be excluded follow up received on 19 May 2021 included patient information allergy, concomitant product use and event rash, does not change company causality assessment and temporal relationship cannot be excluded.
Redness, excoriation, xerosis, and pruritis in vicinity of injection site. Has tried hydrocortisone 1% within the last week with no relief. This was reported to me yesterday by patient' son.
Given INFLUENZA injection at approx 12:30 pm. Present to nurse at 2 pm with slight splotchy rash on (L) neck. Denies SOB & itching, BP 162/82. Pulse 84 RR 18. Advised to contact PMD stat. Patient left. Advised to leave with adult.
Tender, flat, red rash around injection site about 6cm long and 3 cm wide.  Warm to the touch. Developed 7 days after first dose.
pt had screaming, vomiting, & fever;cried from 2:30PM-545PM;
Adverse reaction  is that it made my tinnitus worse.  I've h ad tinnitus for about 10 years but is was not as loud as it is now and didn't interfere with my sleep.  However, since the vaccination, I've noticed the tinnitus is must louder and does interfere with my sleep.  The tinnitus is most noticeably worse in my left ear and there is a pressure in the left ear which makes it feel like it needs to "pop" but I can't get it to pop.