chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. It was reported that the 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated.Nurse confirmed that vaccine was administered to 7 patients on 2 different days. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions. No adverse event reported. No treatment medication details was reported.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
pt recvd vax & was vomiting; fever 102; feb sz; resp arrest; pt turned blue & episodes of resp arrest; dx of poss. roseola;
PT states: "I received a flu vax in my left arm. I noticed some tenderness in the area of my left deltoid 2 days [post vax] that was especially pronounced when I did push-ups, pull-ups or swimming. This tendonitis is still present after several months, although milder. Otherwise my health is excellent. Is it possible that local inflammation from the fax predisposes people to tendonitis? Or is the timing and location of the tendonitis coincidental?
Underarm swelling started at 10:30am Sept 26 (~18 hours post administration), including underarm lymphnode swelling and pain. Symptoms resolved by September 29, approx 4pm.
I contracted COVID-19 on 05/04/2022 with symptoms of cough, sore throat, chills, fever of 102, headache, fatigue, insomnia for a week, myalgia, congestion, shortness of breath, and my uvula was swollen. I was prescribed Paxlovid which I took 2 doses of, Dexamethasone, and Azithromycin, on 05/04/2022. I was ill for 7 days before my symptoms began to improve, but I was ill for 14 days total. I am still experiencing lingering symptoms of headache, and fatigue.
8/21/2107 back pain and headache; 8/22/2017 shaking, abnormal breathing, deep breaths, anger and sweating. Pain and swelling in arm. I took him to the emergency room and was told it is a normal reaction to immunizations.
@ time vax given, stated had sx of URI, temp below 98.6; URI sx have inc since vax given; h/a, generalized backache, nausea (no vomiting); temp ranging 99.2-100 po; also sore throat; seen @ clinic;
Vaccination team came in to vaccinate the patient. Her aid led them right to her and set them up to vaccinate the patient. She was entered into the system and vaccination completed. The patient's children then came in to say she was fully vaccinated already and that was her 4th dose.
In 1998 the patient was vaccinated with 1 dose of varicella virus vaccine live. In the year 2000, the patient experienced chickenpox. The patient was covered with chickenpox. The patient's brother had a similar experience following vaccination with varicella virus vaccine live. Medical attention was sought. No further information is available.
Day of vaccination: body aches, chills, fatigue Day 1 after vaccination: nasal congestion, sore throat, fever, fatigue, body aches.  Day 2 after vaccination: short of breath, fatigue, loss of voice
Round 2 1/2 x 1 1/2 inch rash, warm to touch, red on right upper thigh. Ice pack applied, Tylenol and Benadryl given PO.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at a dose of 400. At the time of the report, HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient already received the second dose and had  been very well, without any problem. No concomitant medication were provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: event outcome added
103 fever; chills, body aches, abdominal pain, nausea, headache, dizziness, fatigue, all lasting 24 hours; the following 48 hours were a lesser version of these symptoms.
dizzy on 2nd capsule & said didn't feel well & had some diarrhea;
"A nurse reported that her 13 month old daughter received her 1st dose of Rota Shield, as well as, DTAP (manufacturer unknown)Acel-Imune (Wyeth), HIB (manufacturer unknown)(Hibtiter, Wyeth) and IPV (Aventis Pasteur SA on vaccines on 7/13/99. On 7/15/99, the infant became lethargic and cranky and developed "severe" diarrhea. On 7/27/99, the infant developed bloody diarrhea and appeared unhappy and uncomfortable." From follow up #1 correspondence received on 05/21/01, it was reported that the patient has recovered from this experience.This case is closed.
SUMMARY OF ADMISSION CHIEF COMPLAINT, HISTORY OF PRESENT ILLNESS, PERTINENT EXAM, LAB & RADIOLOGY STUDIES: From the History and Physical Exam on 12/15:   Patient is a 61 y/o female with PMHx of DM type 2, asthma, HTN, hypothyroidism who presented to TCM ED with complaints to 5 day history of progressive weakness and incontinence that started yesterday. Today the patient had difficulty rising from her chair and once she was able to rise she had urine leaking down her leg. She denies myalgias or specific joint pain. Patient states she was holding a garbage bag underneath her to catch her urine. She denies any dysuria, urgency. Notable increased frequency and polydipsia. She has been taking her insulin as prescribed. She has had a dry cough that is intermittent in "fits." Mild SOB. One episode of a loose stool two days ago but nothing since. Overall, she feels unwell.   She tested positive for COVID-19 today. CT A/P revealed patchy bibasilar ground glass opacities concerning for COVID PNA. She is not currently hypoxic. CMP, CBC generally unremarkable.  Patient would have been discharged home but she was unable to rise from the ED bed. She also has no family or friends that would be willing to come by to help her thus admission was pursued.  Moderna vaccine dates:  4/1/2021 and 4/29/2021
Starting at 10:18am my ears started popping every time i swallowed as if I was changing altitude and it feels like there is a lot of pressure buildup in the front of my head.
Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fever up to 101 degrees
Pain and limited mobility of right wrist and hand,Pain from elbow to fingertips last 2 days,Pain and mobility continues on day 5( April 22) Severe pain left side of front top of head at the hair follicles,feels pruckly,burning sensation ,unable to brush hair or touch hair,if hair moves slightly,there is prickly Pain. Tried Tylenol, no help. Ice provides some relief and keeping hair wet 24/7 along with ice 24/7. Pain continues day 5  on 4/22/2022. This head Pain has occurred for all 4 vaccines for covid. Pain at hair follicle level is excruciating Chills and night sweats only at night for day 1 and 2 ( April 18,19). Also had chills for all 4 vaccines that last 2 days at night time.
The morning after having the vaccine, I woke up pain in my right eye. I had floaters covering my entire field of vision in that eye. I also had flashes occurring during low light in a room. I went to see my eye doctor, Dr and he checked my retina and said everything looked good and that he would keep an eye on it going forward. It took three weeks for the pain, floaters and flashes to subside.
Employee states that she began to have hive and itching and took Benedryl (dose unknown). Employee then presents to Employee Health office to request medication to relieve itching. EE has visible hives and swelling to bilateral arms and legs and is in considerable discomfort. Provided antihistamine as well as hydrocortisone cream. Advised to employee to follow up with PCP.
Two days after vaccination, patient developed an itchy, stinging, fine homogenous papular rash over the face primarily, with a few scattered papules over the neck. It has been hot here lately and patient has been in the sun and exercised. reaction appeared most consistent with miliaria rubra, discussed that it is not clear whether this is coincidental to vaccine administration or actually related. She received the vaccine as a booster, and initial series had been AstraZeneca in her home country (unknown dates)
Rash on face; Rash on both arms; itchiness; lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy and allergic to sulfa and penicillin vk. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. On 22Apr2021 at 09:30, the patient experienced rash on both arms and face, accompanied by itchiness that lasted roughly 30 minutes and slight lightheadedness too. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on both arms and face, itchiness and lightheadedness were recovered on an unknown date in Apr2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-FEB-2018, previously reported as 22-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD injection U, lot number N004631 with expiration date on 07-AUG-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). The administered dose of the vaccine experienced multiple temperature excursions in the range approximately between -13.86°C to 0 °C, for a maximum cumulative time of 449 hours, as recorded by a data logger. The vaccine had not had a previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA002880.
Dizziness and light headedness since the early morning after the second dose of her Moderna vaccine. Pt. went to get up from bed and syncopized hitting her head, left arm and left ribs. Patient sustained 2 displaced left rib fracture and left arm contusion.
Vaso vagal Reaction - patient started feeling dizzy, rolled back eyes, sweats on for head. Blood pressure drop to 80/60. Pulse 62, O2 SAT 99.
delayed reaction arm red spot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (delayed reaction arm red spot) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (delayed reaction arm red spot). At the time of the report, RASH MACULAR (delayed reaction arm red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment for the event included diphenhydramine (Benadryl) cream.
Numbness began late November 2013 - early December. Hospitalized 1/18/2014 with paralysis. Dx Guillain - Barre Syndrome. Released from hospital 2/28/14. To receive Home Health PT.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
tested positive with symptoms quarantined until Feb18; tested positive with symptoms quarantined until Feb18; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 14Jan2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with the first dose on 14Jan2021 and was unable to get the second dose on 04Feb2021, since he tested positive with slight fever and was quarantined until 18Feb2021. The recommendation for him was to have the second dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Erythema and edema at vaccine site posterior deltoid, pruritus; appeared day following vaccination. Allergic.
Around 12/04/2021 or 12/05/2021- I had itching in the area of my scalp, ear, slight ear ache, rash developed on face and up on my hair. It was itchy and uncomfortable for several weeks.  I saw Doctor on 12/15 or 12/20/2021 - he diagnosed it as shingles and prescribed antibiotics. It took about 3 weeks before they resolved, shingles heal gradually.
tendonitis of upper biceps tendon of left shoulder; rotator cuff impingement syndrome of left shoulder; left shoulder pain/ Chronic pain in right shoulder; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 57-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0164) at the age of 56 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Essential hypertension", start date: 22Sep2020 (ongoing); "Mixed hyperlipidemia", start date: 03Sep2020 (ongoing), notes: Hyperlipidemia; "Hypertension", start date: 03Sep2020 (ongoing); "Diabetes mellitus", start date: 03Sep2020 (ongoing), notes: Diabetes mellitus (HCC-CMS) (Chronic); "Osteoarthritis of left glenohumeral joint", start date: 02Feb2021 (ongoing); "Nontraumatic incomplete tear of left rotator cuff", start date: 02Feb2021 (ongoing); "Allergy to Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR oral, start date: 01Jun2021 (ongoing); CALCIUM CARBONATE AND VITAMIN D3 oral; MELOXICAM oral; ASCORBIC ACID oral; NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) oral taken for urinary tract disorder, start date: 08Feb2021 (ongoing); NORVASC oral taken for essential hypertension, start date: 22Sep2020 (ongoing). Past drug history included: Losartan. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot no: ER2613, Route of Administration: Intramuscular, Anatomical site: Right deltoid), administration date: 31Mar2021, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Sep2021, outcome "not recovered", described as "left shoulder pain/ Chronic pain in right shoulder"; ROTATOR CUFF SYNDROME (non-serious) with onset 25Feb2022, outcome "not recovered", described as "rotator cuff impingement syndrome of left shoulder"; TENDONITIS (non-serious), outcome "not recovered", described as "tendonitis of upper biceps tendon of left shoulder".  Additional information: No any relevant test done. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  No follow-up attempts are possible. No further information is expected.
Patient started to feel dizzy , sweaty, and nausea. We gave the patient some water and snacks. Patient was feeling better after staying another 15 minutes on top of the first 15. Patient left with boyfriend.
Woke up this morning with a slight raspy voice and minor chest tightness. Tested positive for COVID-19.
8/18/2023 - 8/20/2023 (2 days) Date of Admission: 8/18/2023  Discharge Date: 08/20/23 Discharge Disposition: Home or Self Care  past medical history of hypertension, hyperlipidemia, pre diabetes, peripheral neuropathy, peripheral arterial disease, osteoarthritis, chronic disease stage I, obesity.  no indication for Decadron due to no hypoxia or requirement of oxygen.  On remdesivir currently day 3.   On empiric Rocephin and Zithromax in hospital to cover for probable superimposed community-acquired bacterial pneumonia as the symptoms going on for more than 10 days.  012M20A 1/28/2021 Moderna  002A21A  3/1/2021 037F21A  11/9/2021 033K212A 4/18/2022 014H22A 11/5/2022
Left arm: redness surrounding injection site (approx 3.5-4 inches in diameter), swelling, heat at site, very sore compared to right arm which other vaccination was given in (patient states she can't move arm)--all localized to injection site. Recommended Tylenol every 4-6 hours (no more than 4g in 24 hours, ice pack at site for 15 minutes every hour or so and Benadryl 25-50 mg every 4-6 hours. Directed pt to contact PCP if symptoms do not resolve or worsen
Clammy skin, fainting spells lasting 10 to 20 seconds.  Had patient to smell ammonium salts.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated intramuscularly with a first dose of HPV. The next day, the patient developed a high temperature if 103 degrees F. Unspecified medical attention was sought.  Subsequently, the patient recovered. The physician plans to continue the series of HPV. Additional information has been requested.
soreness and pain in the arm that has lasted over a week. Warm compresses and tylenol were advised
Starting the day after the immunization patient had a runny nose, felt sick to her stomach and is dizzy. Still does not feel well today.
1st dose on 04May2021, 2nd not received; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 4th May 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date:20-SEP-2022 Reporter's Comment: The case was reported by the patient. The reporter was not willing to share DOB (date of birth). The reporter reported that, she received her Shingrix vaccine in an unknown arm.  The reporter reported that, pain at the injection site for a few days.  The reporter reported that, she had not received her second Shingrix vaccine yet (Inappropriate schedule of vaccine). The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.