chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nausea; Fatigue; Dehydration; Light headed; Fever; Pain in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DEHYDRATION (Dehydration), DIZZINESS (Light headed), PYREXIA (Fever) and HEADACHE (Headache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced DEHYDRATION (Dehydration), DIZZINESS (Light headed), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in arm), DEHYDRATION (Dehydration), DIZZINESS (Light headed), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She is bleeding behind retina so she can't see properly; Clot in retinal branch; She can't see properly; She sees blurry; Light nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly) and RETINAL VASCULAR OCCLUSION (Clot in retinal branch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 17-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) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced EPISTAXIS (Light nose bleed). On 22-Apr-2021, the patient experienced VISION BLURRED (She sees blurry). On 29-Apr-2021, the patient experienced RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly) (seriousness criterion medically significant), RETINAL VASCULAR OCCLUSION (Clot in retinal branch) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (She can't see properly). At the time of the report, RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly), RETINAL VASCULAR OCCLUSION (Clot in retinal branch), VISUAL IMPAIRMENT (She can't see properly), VISION BLURRED (She sees blurry) and EPISTAXIS (Light nose bleed) outcome was unknown.            Patient started with light nose bleed 2 days after receiving vaccine. Then 2 weeks ago, she developed problem with her eyes. She mentions that she sees blurry. She went to doctor on 29Apr2021 and doctor said that there was a clot in retinal branch and she is bleeding behind retina so she can't see properly.  Treatment medication includes: Vastin Injection for the eyes Concomitant medication includes: BP medicine  Company comment 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 16-JUN-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K008198 with expiration date 05-JUN-2016, dose, anatomical location and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Pain right chest wall, shingles to right chest and back. Prescription given for Valtrex 1 gm TID times 7 days.
My arm was sore after administration, which occurred at approximately 8:15. At 3:00 that same afternoon, I began running a fever, which ranged anywhere from  99.8 - 102.6 over the next few days. I experienced body aches, fatigue, chills, nausea and vomiting (one episode), and headaches. I did receive a COVID (Rapid and PCR) and Flu test on the following Monday, all of which came back negative. On the 21 and 22 I woke up without a fever, but within approximately 3 hours of waking up my fever would return. Fever was treated with a rotation of acetaminophen and ibuprofen with success, however, it never dropped the fever below 99.0.
Fainted for a period of 4 seconds. Initial BP 104/68, pulse 78, o2 99%. Patient transferred to gurney. Nurse offered water to drink. Patient feels better after drinking water. BP after 15 minutes 114/68. Advised to drink more water when patient goes home. Patients mother stated her daughter fainted 2 years back due to dehydration. Patient stated that she did not drink enough today. Advised to consult Primary physician. Patient stated she got feared and panic due to vaccine. Patient feels better and left for home with mother. Patient stayed under observation for 30 minutes.
1 in redness on Rt arm where MCV-4 was injected, 1 1/2 in redness where inj of Tdap was injected, place warm compress on each arm every 4 to 6 hrs.
SKIN RASH BENADRYL 25 MG 4 TIMES A DAY BENADRYL CREAM HC 1% DOCTOR APPOINTMENT 4/6/2021
Patient had Moderna Dose 1 vaccine administered at 8:55am and at 9:05am patient advised observation nurse that he was feeling cool, nurse then asked if the patient was feeling dizzy and right after patient?s head slumped over and his eyes rolled back and he went unconscious for 10 seconds. Immediately after, observation nurse ran and grabbed the patient's feet so he wouldn?t slide off the chair and removed his mask. EMS was called right away. Patient was diaphoretic, clammy and pale. Patient then was alert and oriented x4. Blood pressure was low at 90/56 and pulse at 66. Patient did not have anything to eat prior to coming in for vaccine. No known allergies.Crackers were given to patient and EMS arrived to the scene. Blood pressure was taken by EMS and blood pressure was 90/74. Patient was taken to hospital via EMS.
The night of the vaccine, patient started feeling very fatigued. Sleep 20 hours each day from Monday night through Friday. Saturday had chills, nausea, and temperature of 95. Also experienced "brain fog" the whole time. By Sunday she was fine.
No reported adverse event- 2nd dose given out of CDC guidelines.  2nd dose was administered at 21 days, instead of 28.  The patient reports having no issues with either vaccination.
I received the Gardasil vaccine and walked out of the room. As I exited I lost vision and hearing and collapsed, still conscious and very nauseated. Difficulty breathing occurred once vision returned. Hearing did not return for 10 minutes and I heard a ringing, metallic sound every time I talked. Vision was yellow and green, and my face had lost all color (pale/green). 15 minutes after the shot I had abdominal cramps and diarrhea. I drank some water and was then freezing cold and very weak. I felt more normal by the end of the day. On the second and third day, I had swelling and tenderness at the injection site.
Received First Dose with Heplisav-b and Second Dose with Engerix; Initial Report Received on 22-Feb-2022  A registered pharmacist reported that a 33-year-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.  No medical history was reported. Allergies reported included codeine.   No concomitant medications were reported.  On 15-Aug-2021, the patient received dose 1 of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).  On 15-Sep-2021, 32 days after having received the HEPLISAV-B vaccine, the patient received Engerix-B (Lot #, expiration date, NDC #, route, and injection site unknown) as the second dose.  On 22-Feb-2022, 191 days after having received the HEPLISAV-B vaccine and 160 days after having received the Engerix-B vaccine, the patient came to a different pharmacy for the third dose. The patient reported to the pharmacist that she received HEPLISAV-B vaccine as the first dose and Engerix-B vaccine as the second dose. The patient did not report any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient fainted after receiving IZs. Was leaving in clinic when syncopal episode occurred. Patient moved to triage room, laid down on exam table BP was 93 systolic and pulse was lowest at 48 After 5 minutes, patient was sitting up. Drank water and ate snack. BP and pulse returned to normal range for age. Held for another 15 minutes before being release home
Red, warm and swollen thigh's greater on left side. Suggested Tylenol to be given as needed until swelling resolved or to call if worse.
Nausea 1 hour after vaccine. Nausea and vomiting x2days, fatigue. No fever, chills.
Patient's husband reported that patient has been feeling nauseated since she received the vaccine and that she has started having stomach cramps. He reported that they are concerned about her having blood clots and he was informed to take her to the her primary care if that is a concern. He bought OTC aspirin and reported that he will have patient take it for the new two weeks. He was advised to take patient to the doctor is nausea and cramping persist.
Extreme chills and shaking Headache Major legs cramps Nausea  Burning eyes
I take a beta blocker and I noticed in early February I could not take a deep breath. I went in to see my physician, prior to seeing him I had stopped taking my Lipitor as he had increased the dose. We discussed if this could be causing the problem and agreed to that a change may help. I am now taking Crestor. Occasionally, I notice I cannot get a deep breath so I feel the adverse event may have resolved.
Information has been received from a PharmD concerning his 13 month old daughter who was vaccinated on an unspecified date with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot not available). Seven days later, she experienced a febrile seizure. The pt was not hospitalized. Unspecified medical attention was sought. Treatment was not required. Subsequently, the pt recovered from the febrile seizure. Upon internal review, febrile seizure was determined to be an other important medical event. No further information is available.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:32 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.46 for dose administered on 28-Feb-2021 and 83.54 for dose administered on 28-Mar-2021.  Concomitant product use was not provided by the reporter.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature of 27 and 26 degrees Fahrenheit from 9:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
2" x 3" warm swollen red area 1" below inject site on lt arm; no fever;
Full body aches, joint pain, chills, fatigue, arm pain around the injection site, fever of up to 101.2, lack of appetite
Information has been received from a registered nurse concerning a 69 year old male with hypertension and hypercholesterolemia and no allergies who on 20-SEP-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck) (Lot #658212/0887U).  Concomitant therapy included meloxicam (Mobic), omega-3 marine triglycerides, chondroitin sulfate sodium (+) glucosamine sulfate, atorvastatin calcium (Lipitor), finasteride (MSD) and nifedipine (Nifedical XL).  There was no illness at the time of vaccination.  On 23-SEP-2007 the patient developed a clear fluid filled blister at the injection site.  The lesion was the size of a nail head.  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been received from registered nurse who stated that the patient had small blister (nail head sized) noted on 23-SEP-2007 and was flatter day of report on 24-SEP-2007.  The patient had recovered on an unspecified day.  No diagnostic laboratory tests were undertaken.  There was no adverse event following prior vaccination for the patient or patient's sibling.  No further information is expected.
Vaccine  administered was expired.  Expiration date 01/14/2021.   No  adverse symptoms  or signs  observed during 1 hour post-vaccination observation.
Headache, Fever, NauseaVomiting, injection site itchiness, headache, dizziness, body aches Narrative:  Pt reported Nausea, injection site itchiness, headache, dizziness, body aches, fever post covid vaccine dose #2 on same day of injection. Pt treated with imodium & tylenol  Other Relevant History:
The patient states that she has had continued soreness and aching in the shoulder where she received the flu vaccine.
No issues on Dec 18,2021  Dec 19th 2021: The day after the vaccination I woke up with a slight sore arm. 7:00am My entire body was sore, and I had a horrible pain going up my arms and legs. My legs felt completely charlie horse in every single spot. By 12pm Dec 19th 2021, Chest tightness and I was nauseous and had a horrible headache, felt like I was gonna vomit (which I never vomit). By 1pm Dec 19th 2021, I had a fever of 101.4 and felt extremely hot. I took some naproxen and fell asleep until 3pm. The headache subsided a little bit, and the fever seemed to break. My legs still feel extremely cramped up and charlie horsed. I feel pain in every single muscle, including my abdominal muscles. My back has increased in pain, and my arm has increased in swelling. Dec 20th, I woke up around 3a.m and was soaked in sweat. Couldn't find the thermometer.  Dec 20th my arm had a baseball sized knot in my lymphnode and a large swell around the injection site, cant move arm at all without tremendous pain. Dec 21st, The horrible pain lasted all day, still had a headache and took naproxen twice on Dec 20th. Woke up with a sore arm, lypmhnode is still swollen and extremely sore. I have been taking the advice of CDC website, and kept my arm moving, but I am resting and not over doing it just lightly. Dec 21st, pain in my back is a lot worse. in the middle of my back, and my chest when I breathe. Headache is mild.   It has been 3 days, and I am starting to worry about increased problems.
Patient received a Pfizer vaccine that was stored under conditions that departed from the manufacturer's specifications at the store level. The patient was noticed on 03/15/2022 when the information was brought to our attention by our corporate office. We recommended that the patient be re-vaccinated as the prior dose may not provide the optimum benefits of the vaccine.
Patient didn't receive full or if any of the Vaccine upon injection; Patient didn't receive full or if any of the Vaccine upon injection; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient didn't receive full or if any of the Vaccine upon injection) and UNDERDOSE (Patient didn't receive full or if any of the Vaccine upon injection) 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 INCORRECT DOSE ADMINISTERED (Patient didn't receive full or if any of the Vaccine upon injection) and UNDERDOSE (Patient didn't receive full or if any of the Vaccine upon injection). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient didn't receive full or if any of the Vaccine upon injection) and UNDERDOSE (Patient didn't receive full or if any of the Vaccine upon injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Patient presented with rash and lesions to left periorbital region 11/15/2021. 11/16/2021 diagnosed with Shingles and prescribed acyclovir po 400mg Qid x 10 days and gabapentin 100mg give two capsules by mouth tid x 10 days. Resident sent to emergency department 11/16/2021 due to increased swelling/ blistering to left periorbital region.
Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Most symptoms gone in 20 hrs. After that a few days feeling sluggish.
Pfizer vaccine was administered outside - reported by patient  I26.99 ACUTE PULMONARY EMBOLISM 12/17/2021 CRYSTAL ARTHRITIS I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/17/2021 CRYSTAL ARTHRITIS I26.99 ACUTE PULMONARY EMBOLISM 12/17/2021 ANGINA, UNSPECIFIED I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 12/17/2021 ANGINA, UNSPECIFIED
Hospitalized for fever and decreased WBCs post bilateral lung transplant 2015 and renal transplant 2020.
10/19/04: left thigh, increased heat, redness, in 3-4cm area around injection site, elevated, hard.  10/20/04Local reaction, rarely cellulitis. Treated with antibiotic. Keflex 250/5ml x 7 days. 10/22/04: improving, cellulitis, continue antibiotic.
10 days p/vax pt devel fine, reddened rash on arms, legs, & face & low grade fever;
COLD; HOARSE AND RASPY VOICE; RECURRENT COUGH; WHEN INHALES PATIENT COULD TAKE DEEP BREATHS,WHEN ABOUT TO EXHALE, FELT LIKE A HAND IN NECK THAT NEEDED TO COUGH TO BE ABLE TO EXPEL THE AIR INSIDE; WEIGHT GAIN; This spontaneous report received from a physician concerned a 45 year old female. The patient's weight was 250 pounds, and height was 63 inches. The patient's past medical history included face swell, and concurrent conditions included cough variant asthma, alcohol use, sulfa drugs allergy manifested by hives, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 180206, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number and expiry were not reported) 15 mg, every 1 total, from JAN-2020, frequency was not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2020, the subject experienced when inhales subject could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside. On 2020, the subject experienced weight gain. On APR-2021, the subject experienced recurrent cough. On 21-MAY-2021, Laboratory data included: CT scan (NR: not provided) No pneumonia, No significant findings. On JUN-2021, the subject experienced hoarse and raspy voice. On 23-JUN-2021, the subject experienced cold. Treatment medications (dates unspecified) included: mometasone furoate, budesonide/formoterol fumarate, benzonatate, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient had not recovered from hoarse and raspy voice, weight gain, recurrent cough, and cold, and the outcome of when inhales patient could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside was not reported. This report was non-serious.
I had a swollen, red, hot deltoid the evening of the injection.  It went into my entire arm down into my hand with massive edema, hot to touch, extreme pain , immobility, headache, chills, NO fever, but, the edema which was 70 percent larger than the other arm lasted 5 days.  It started to recede on day 6.  I have startling photos that I would like to send with this report.
I awoke on the morning of 02/04/2021 (the day after my 2nd Moderna vaccination) with severe chest pain and moderate shortness of breath.  I called the nurse in charge of running the vaccination site and was told it was possibly a normal reaction to the vaccine, or maybe some other concurrent illness.  So, I waited a couple of days and started feeling a little better. Then I experienced a sudden worsening again, this time with radiation into the middle of my upper back, and went to the ER for Evaluation.  In the ER they drew bloodwork including a CBC, chemistry panel and cardiac enzymes (Troponin).  All returned relatively normal.  An EKG and chest x-ray were performed as well as a CT angiogram of the chest to rule out both a pulmonary embolism and dissecting aortic aneurysm.  Eventually, I was discharged and instructed to follow up with Cardiology.  This is when I underwent evaluation by MD who diagnosed me with pericarditis. I have been doing much better since.