chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacy technician referring to a 16 year old female patient. The patient's pertinent medical history was not reported. The patient's concurrent conditions included chronic sinusitis, chronic rhinitis and unspecified environmental allergies. Her concomitant medications included fluticasone propionate(FLOVENT) and cetirizine hydrochloride (ZYRTEC). On an unspecified date in 2008, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (reported as "high-risk group") and asthma (route of administration, lot # and expiration date were not reported). On an unspecified date in 2017, the patient was vaccinated with another dose of PNEUMOVAX 23 for prophylaxis and asthma (route of administration, lot # and expiration date were not reported). In July 2017, the patient was diagnosed with pneumonia. It was stated that the patient was prescribed with cefdinir and ceftriaxone sodium(ROCEPHIN) and recovered from the event on an unspecified date. In January 2018, the patient was diagnosed again with pneumonia. The patient was treated again with cefdinir and ceftriaxone sodium(ROCEPHIN) and recovered form the event on an unspecified date in February 2018. In March 2018, the patient underwent a "titre for pneumonia" which showed low antibodies (antibody test abnormal). At the time of this report, it was unknown if the patient had recovered from this event. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review, both episodes of pneumonia were determined to be medically significant events.
Swelling the size of a softball under the left armpit; Swelling behind left ear; Swelling of left jaw; Trouble swallowing food; Feeling like throat was swelling; Sensation of throat closing; Really bad headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling the size of a softball under the left armpit), EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food) and PHARYNGEAL SWELLING (Feeling like throat was swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetes since 01-Jan-2011 and Blood pressure abnormal since 05-Jan-2018. Concomitant products included LOSARTAN from 05-Jan-2018 to an unknown date for Blood pressure abnormal, METFORMIN HYDROCHLORIDE (GLUCOPHAGE) from 01-Jan-2003 to an unknown date for Blood sugar abnormal.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, 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 SWELLING (Swelling the size of a softball under the left armpit), EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food), PHARYNGEAL SWELLING (Feeling like throat was swelling), THROAT TIGHTNESS (Sensation of throat closing), HEADACHE (Really bad headache) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling the size of a softball under the left armpit) was resolving, EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food), PHARYNGEAL SWELLING (Feeling like throat was swelling), HEADACHE (Really bad headache) and FATIGUE (Fatigue) had resolved and THROAT TIGHTNESS (Sensation of throat closing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Lot number of dose 1 and dose 2 were added. On 19-Jul-2021: Adverse event throat constriction, current conditions, concomitant medications all were added.
After the first shot I felt like I had Covid again. Fever, body aches, rapid heart rate, generally just miserable.
Swelling at injection site with tenderness and flu-like symptoms; fluids and tylenol
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2019, the patient was vaccinated with the first dose of improperly stored VARIVAX injection, subcutaneously, lot # R026715, expiration date: 18-SEP-2020 (exact dose was not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion of minus 10.5 degrees Celsius for 1 hour and 11 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA001668: Original Case: 1903USA001655.
This spontaneous report was received from a pharmacist refers to a 81 year old female patient. Medical history and concurrent conditions were reported as none. On 11-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L031272, exp.:19-Nov-2016) (dose, frequency and route were not informed). Concomitant medications were reported as none. On an unspecified date, the patient experienced rash at the injection site, itching and redness. The patient was evaluated by her physician and prescribed NYSTATIN to apply topically to the area of reaction. No lab tests were performed. At the time of this report, the outcome of injection site rash, pruritus and erythema was reported on 09-JAN-16 as recovering. Additional information has been requested. Additional information is not expected.
difficulty breathing, shortness of breath, chest pain, and racing heart beat, body aches. The night of 2/11/22 i had body aches 2/12/22 went to work and had difficulty breathing and chest pain with exertion and wheezing. Flu like symptoms. currently Shortness of breath and dull chest pain have been pretty constant til today 12/11/22.
Swelling, bruising,black and blue, pain. Patient went to ER and was told to put ice pack on arm.
Noticed blood present in semen on 4/4/2021. Blood persisted though quantity decreased daily to 4/12/2021. Not clear if fully resolved as of 4/13/2021 although it appears to be.
Mild photophobia; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 18Dec2020 (19:15) at a single dose on the left arm for COVID-19 immunization at the hospital. Medical history included allergic rhinitis and cashew allergy. Concomitant medications included fexofenadine, ergocalciferol (VIT D) and cyanocobalamin (VITAMIN B12). On 06Jan2021 (17:45), the patient had mild photophobia within 5 to 10 minutes of the first dose of vaccination. The patient did not recognize the symptom at the time. The patient had self-administered over-the-counter (OTC) oral analgesics as treatment for the event. The outcome of the event, mild photophobia, was recovering. The patient did not have COVID-19 prior to the vaccination, and had not been tested positive for COVID-19 since the vaccination.  Information regarding lot/batch number has been requested.
After my first does of Pfizer vaccine five days, I felt hard to breath after I fought with my family members. It last 1.5 days and then recovered by myself.  I felt dizzy in my first shot too.  In my second shot, I didn?t feel I could not breathe.
2 days post vax pt broke out w/shingles on rt shoulder; site of vax very painful was afraid to take shot this year;husband did & 2 days later got the shingles again on waist;
Had redness/erythema- left biceps-site of injection no abscess ROM (Nl), Chills x 10 mins x 1 night no SOB no hematur no LP no seizures.
Case number PHEH2015US015698 is an initial spontaneous report received from a health care professional on 12 Aug 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. The patient received an expired dose of FLUVIRIN (batch number: 1412301A, expiry date: 30 Jun 2015) intradermally instead of tuberculin (TB) skin test (other manufacturer, batch number; not reported) on 12 Aug 2015. It was reported that patient had a big welt at the vaccination site on the same date. The outcome, seriousness and causality of welt were not reported. No further information was provided.
my menstrual cycle on day 8 and ordinarily my mensural cycle is no more than 4 days; This is a spontaneous report from a contactable consumer (Patient). A 53-years old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0158; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration on 30Apr2021 as 2nd dose, single, dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Consumer stated, that am 53 years old, obviously my cycle ordinarily went for about 3-4 days menstrual cycle and it's been onto well over 7 days. The first time this is happened, menstrual cycle on day 8 and ordinarily my mensural cycle is no more than 4 days. I got my second dose, Pfizer shot or vaccine 30Apr2021 and my cycle as the month of May and So this started after my second round of the Pfizer Vaccine, never had it that extended beyond 4 days so this out of the ordinary, little heavier than normal as well. No, none. I don't have any history. Consumer stated, within the past year (as the Lab test was done previous year hence not captured in tab) it have my lab data normally run during the physical. Everything was normal. CBC, my lipids, everything was normal nothing abnormal. The patient experienced my menstrual cycle on day 8 and ordinarily my mensural cycle is no more than 4 days on an unspecified date with outcome of unknown. No follow-up attempts are needed. No further information is expected.
LT arm was so sore I could not move it. 01/19/2021 Rash all over my up body (shoulders neck head), arm still sore. Took over the counter meds. Lt arm still hurts 01/20/2021 No more rash, but shoulders and upper back are super tight. I am also super tired today. 01/21/2021
3 hours after receiving the flu shot (inactivated influenza vaccine 2008-09) I was stricken with the most severe back pain I've ever felt, except for when I had back surgery ~3 years ago. It felt like a disc in my lower back approx. L4 or L5 had slipped half a notch and I experienced exruciating pain. It was all I could do to drive home and go to bed, laying face down until morning. I slowly recovered over the next 3 days.
No adverse event; Inappropriate schedule of vaccine administered.; This spontaneous report was received from a Nurse, referring to a female patient of unknown age. The patients concurrent conditions, pertinent medical history and concomitant medications were not provided.     On 31-JUL-2020 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis.  Other suspect therapies included varicella virus vaccine live (oka/merck)(VARIVAX). The patient was administered again with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) on 07-AUG-2020 (inappropriate schedule of product administration).  No further Adverse events or Product quality complaint were reported.
Noted a 2.5 cm welt lateral to injection site no other symptom other than soreness at injection site.
I started to feel breath shortness and breast pains nearly a week after the vaccination. I almost fainted out at that time so dropped by an urgent care near home. ECG and other basic test (e.g. blood pressure) were conducted, which were not far from normal. The practitioner recommended taking some NSAIDs and it was working only a little. I am still suffering from breast pains at night.  After a couple weeks, I also had severe rashes over the whole body. I visited a specialized doctor and was treated with a steroid ointment. The rashes went away a few weeks later and I am now fine.
COVID arm but milder than the after the first vaccine for COVID - happened immediately. It only happened at night when I went to bed and when I moved. I had to stare straight ahead and then it would go away. Every single time I moved it would come - a type of dizziness. If I tried to turn over - it happened again. Benign Paroxysmal Positional Vertigo. BPPV - it usually lasts a couple weeks, they say. Mine is 99% gone. I have only had one little tinge of it in the last 4 or 5 days. So, it only lasted about 2 weeks. Once I was upright, I didn't have any symptoms at all. It was only when I was lying down. Has to do with the inner ear. No treatment. I checked in with my family doctor and she said it sounds typical to this condition. By the time I called her, it was starting to decrease. If my head was in the back condition and head turning side to side. When I leaned back into the bowl where they wash your hair at my recent haircut - I did have a momentary occurrence of the symptoms. It's still happening but not very often.
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA333678 (same reporter). This case involves an adult male patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was reported as a nurse made a mistake and gave the pediatric dose to two adults using the pre-filled syringe. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Itching of skin, Arms, Legs, Chest, feet. Took a oatmeal bath, used eucerin cream and nothing helped. Took a allergy test weeks later, and now taking allergy shots, but nothing is helping. Still have the hives everyday.  Benadryl helps the itching temporarily, but can't take it all the time, because it makes me drowsy and I do have to work.
20JAN94 9PM became fussy-mom giving APAP & Mylecon; middle of noc 21JAN95 early AM high pitch crying-lasting 30-45 mins then catnap 15-20mins, cont all day; t101 ax; fussy, trembling (not sz), vomited, black sticky stool, eyes red & watery;
Myocarditis  Patient is a 14 y.o. male with no past medical history who presented to the ED today due to acute chest pain. He received his second mRNA COVID vaccine on 7/28, that night he developed a fever and over the next two days had some muscle aches, fatigue and continued fevers. This morning he woke up with left sided chest pain, not reproducible and unaffected by his breathing. He denies any palpitations, shortness of breath or syncope. He was seen in urgent care which found ST elevation on EKG and sent him to HDVCH  ED. EKG here confirmed ST elevation, troponin found to be elevated at 147. His chest pain improved with ibuprofen. He was admitted to cardiology service for continued monitoring.  HOSPITAL COURSE: Patient is a 14 y.o. male with no past medical history who presented after 2nd mRNA COVID vaccine with chest pain, ST changes on EKG and elevated troponin. He was admitted to the cardiology service for ongoing evaluation of myocarditis. He was started on ibuprofen every 6 hours for inflammation with resolution of his pain. His ECHO demonstrated normal cardiac structure and function. EKG at time of discharge showed improvement in ST elevation. Serial troponin levels continue to be elevated, but not rapidly increasing (147, 229, 243, 267), he will get a repeat troponin tomorrow as outpatient. ID was consulted this admission and myocarditis labs are still pending. He will continue 600mg Motrin TID until troponin level improves. He will have scheduled follow up with Dr  in 3 weeks.
Roughly 10 minutes after injection, felt "wave" of dizziness which then lead to extreme blurriness, some difficulty breathing, clammy skin all over.  Extreme blurriness only lasted for a couple minutes, but basically could not see anything. (could see light outside, but no definition)  Rest of reaction lasted approximately 10-15 minutes. Never had reaction to previous flu shots and this is the fourth one I've received at this very location.  Only difference I've noticed when looking at previous paperwork is that all the other times I received the preservative-free shot while this time I got the one with preservatives because the other was not available.
About a week after the 2nd dose, I started to get a rash on my feet and legs and private areas.
For the 2 days following the shot I had a deep fatigue; 20 -25 min post shot I had a flush go through my mouth; My lips were tingly and then all around my mouth felt slightly numb; My lips were tingly and then all around my mouth felt slightly numb; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 06Mar2021 at 08:45 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer on an unknown date in 2009, sulfonamide allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (B12), fish oil (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN), Ibupr (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) taken for an unknown indication in an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 09:15, 20 -25 min post shot the patient had a flush go through her mouth. The patient lips were tingly and then all around her mouth felt slightly numb. It only lasted 10 min or so. The patient had no breathing issues. On 08Mar2021, For the 2 days following the shot the patient had a deep fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, 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 events had flush go through her mouth, her lips were tingly and then all around her mouth felt slightly numb were recovered on 06Mar2021 and deep fatigue was recovered on 08Mar2021.   No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX. On 31st July 2018, 1 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 60 or 61 year. The patient received SHINGRIX vaccine on left arm. The next day after receiving SHINGRIX, the patient reported that he developed a rash that was itchy, but not painful, in the left arm where he received the injection. The rash was intermittent for the next 3 weeks, and then resolved. The reporter consented to follow up.
Sunday 1/17/21 at approximately 6pm began with cough, mild sinus headache, mild shortness of breath. Monday 1/18/21 morning around 8am, awoke with headache, continued coughing, began taking Tylenol and taking Vitamin C. Tuesday 1/19/21 morning woke up feeling worse. Pain to bilateral shoulders, body aches, cough and runny nose.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, LIQUID PEDVAXHIB of lot # K008878 with expiry date 23-MAR-2017 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored PEDVAXHIB. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the several reports received from the same source. Additional information has been requested.
On the 13th day after receiving first shot at around 230pm I was eating late lunch in restaurant when I felt a flutter on left side of  my face, my lips went numb and my taste dissapeared.  My left eye began to burn and tear profusely.    My mouth felt like it was on the side of my face and I had trouble drinking and chewing.  I  thought it was an allergic reaction to the food. Three hours later I looked at my face and was alarmed because my entire left side was paralyzed and drooping and my mouth was twisted to the right.  I rushed to  Hospital in around 6:30 pm.  After numerous test (inc brain scan) and consultation with Neurologist I was diagnozed with Bell Palsy.
Patient given expired vaccine. Vaccine Expired on 08/15/2018 and immunization given on 08/21/2018. Patients mother was called and notified, patient will be coming in 1 month to get revaccinated.
This case was reported by a nurse via sales rep and described the occurrence of pain in a 59-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to Shingrix. Additional information received as follows: For tolerance to next dose, refer case US2018170158.
10/29/21 patient presents to a local HCF for elevated BPS, gestational hypertension, third semester, asymptomatic COVID-19 infection. No pertinent past medical history.
Patient developed three "boils" BELOW injection on left arm. They were sore, but disappeared within 3 days. Patient also developed "big" blister on upper palate of mouth. Painful, but disappeared quickly.
Sore arm day off and for 48 hours following, severe abdominal pain approx 36 hours after injection