chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart Problems; Has Not Received the Second Dose 6 months after First dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (Heart Problems) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CARDIAC DISORDER (Heart Problems) (seriousness criterion hospitalization). On 02-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose 6 months after First dose). On 30-Jun-2021, CARDIAC DISORDER (Heart Problems) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose 6 months after First dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  After first dose, patient had Heart Problems and she was hospitalized. She had issues for a long time and did not receive the second shot. Pharmacist does not know the details of the heart problems.  Company comment: There is not enough information to assess the event of cardiac disorder although a temporal association exist between the event  and mRNA-1273 use as the disorder was not specified and the patient's medical history and concomitant medication details are lacking.  Additional information has been requested. The event of has not received the second dose 6 months after first dose is assessed as not applicable.; Sender's Comments: There is not enough information to assess the event of cardiac disorder although a temporal association exist between the event  and mRNA-1273 use as the disorder was not specified and the patient's medical history and concomitant medication details are lacking.  Additional information has been requested. The event of has not received the second dose 6 months after first dose is assessed as not applicable.
Headache, Arthralgia, Fatigue, hills, injection site pain and swelling, tenderness and swelling of the local lymph nodes on the injection side Narrative:
Face flushing; temperature, adverse body sensations; rapid heart rate; headache; dizzy; chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Lot number: FM0698) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "wasps" (unspecified if ongoing), notes: known allergies: wasps; "adhesives" (unspecified if ongoing), notes: known allergies: adhesives. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: FC3184), for Covid-19 Immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: FA7484), for Covid-19 Immunization. The following information was reported: FLUSHING (non-serious) with onset 24Feb2022, outcome "recovering", described as "Face flushing"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 24Feb2022, outcome "recovering", described as "temperature, adverse body sensations"; HEART RATE INCREASED (non-serious) with onset 24Feb2022, outcome "recovering", described as "rapid heart rate"; HEADACHE (non-serious) with onset 24Feb2022, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 24Feb2022, outcome "recovering", described as "dizzy"; CHILLS (non-serious) with onset 24Feb2022, outcome "recovering", described as "chills". The events "face flushing", "temperature, adverse body sensations", "rapid heart rate", "headache", "dizzy" and "chills" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of flushing, body temperature abnormal, heart rate increased, headache, dizziness, chills.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, if unknown if the patient had been tested for COVID-19. The patient experienced Face flushing, temperature, adverse body sensations, rapid heart rate, headache, dizzy, chills.   No follow-up attempts are possible. No further information is expected.
shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix. In June 2020, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 64 or 65 years. The patient received the first dose of Shingrix one or two weeks prior to time of reporting and that one week later, the patient had shingles. The reporter consented to follow up.
Knees were tight; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Knees were tight) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced JOINT STIFFNESS (Knees were tight). At the time of the report, JOINT STIFFNESS (Knees were tight) outcome was unknown.     Concomitant product use was not provided by the reporter.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Rinvoq (Upadacitinib) for the event of knees were tight was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Had a very sore right arm; Patient received the Moderna booster shot after the Pfizer primary series; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a very sore right arm) and INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna booster shot after the Pfizer primary series) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced PAIN IN EXTREMITY (Had a very sore right arm) and INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna booster shot after the Pfizer primary series). On 14-Dec-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna booster shot after the Pfizer primary series) had resolved. At the time of the report, PAIN IN EXTREMITY (Had a very sore right arm) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.  The patient received the Moderna booster shot after the Pfizer primary series.   This case was linked to MOD-2021-436174, MOD-2021-437043 (Patient Link).
Patient experienced a fever, chills, paleness, a swollen and red arm that achieved the size of a baseball.  She did not seek medical attention and did not verify her temperature.
Pfizer-BioNTech COVID-19 Vaccine  Itching, swelling and redness at site of injection.
Post vax, the pt experienced fever, nausea, headache, syncope, and seizure activity.
I reported on my last v-safe check in that I had the flu since my last reporting. it was not related to my last COVID vaccine shot. I got a call from the CDC v-safe program wanting to know more about my health event. One option was to report back here. That is what I'm doing. My health event getting was the flu 2 months after my last COVID shot. I had no reaction to my last COVID shot.
COVID19 Pfizer Booster shot - received Thur, 9 Dec 21 at 1500.  On Sat, 11 Dec 21, I began to notice swelling and an area of pain upon palpation in the area of my left armpit.  I also had discomfort upon moving my arm due to the swelling/lump.  The swelling was visible to both me and my husband.   As of Tue, 14 Dec 21, the swelling has reduced enough to not cause discomfort upon moving.  However, the pain is still there upon palpation in my left armpit area.  I have reported this to my PCM and I have a virtual appointment with him tomorrow.
Patient has no reaction at the time of administration.  However, this is his 3rd dose and he shouldn't have received a 3rd dose.  He already received 2 doses back in 2020.
I had no fever or anything after the vaccine, until 3JAN2023 when I was vomiting. when I went to sleep and woke up, I started to feel tingling on my right side of my body, I couldn't drive and had my husband drive me to the doctor. I had extream blood pressure and had a stoke.
Seven minutes after receiving the vaccine client began to convulse followed by syncope. EMS was called. Client was caught before she fell. and stabilized shortly after. She states "this is something that happens to her regularly bc she has a fear of needles." Vitals taken are as follows BP 176/123, SPO2 99%, pulse 74.
Pain; FATIGUE; vision abnormal; Headache; muscle ache; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Migraine on 01-Dec-2010, Diverticulosis on 01-Mar-2007 and Osteoarthritis on 15-Apr-2001. Concurrent medical conditions included  (Sulfa  NSAID). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 21-Oct-2019 to an unknown date for Sleep deprivation, DIAZEPAM from 21-Oct-2019 to an unknown date.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced FATIGUE (FATIGUE) and PAIN (Pain). At the time of the report, VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown.            On 29apr2021, post vaccination, the patient stated that she experienced symptoms of fever, aches, body pains and migraines.   No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: No specific follow-up information recorded.
Large red swelling around the shot area. Red and itchy and hot to the touch. No breathing issues.
BIG RED ITCHY RASH ON THE ARM BUT NOT PAINFUL, PATIENT ADVISED TO TAKE BENADRYL, APPLY ICE ON THE AREA AND LET US KNOW IF IT GETS WORSE.
I WAS SLEEPING AND AT APROXIMATELY 2:OO AM I STARTED CHOKING, I COULDNT BREATH AT ALL, IT LASTED LIKE 30 SECONDS BUT FELT LIKE AN HOUR!!! I STANDED UP AND MAKE A VERY STRONG EFFORT TO BREATH AND STARTED BREATHING A LITTLE BIT AND THEN NORMAL. MY HEART BEATED VERY STRONG, I WAS VERY SCARED!! I SHOULD NOT TAKE THE SECOND DOSE, RIGHT?
Welt (hot, red, swollen) from injection site almot to inside elbow. Also nausea and headache. Cleared after 3 days.
Patient developed a cough on 8/3/2021.  Tested positive for COVID on 8/5/2021.
This case was reported by a physician via sales rep and described the occurrence of cellulitis of arm in a 12-year-old male patient who received MENVEO (batch number M15079, expiry date 30th April 2017). On 21st July 2016, the patient received MENVEO .5 ml. In July 2016, less than a week after receiving MENVEO, the patient experienced cellulitis of arm (serious criteria GSK medically significant), erythema, swelling arm and limbs stiffness. The patient was treated with KEFLEX. On 25th July 2016, the outcome of the cellulitis of arm, erythema, swelling arm and limbs stiffness were recovered/resolved. The reporter considered the cellulitis of arm and erythema to be related to MENVEO. It was unknown if the reporter considered the swelling arm and limbs stiffness to be related to MENVEO. Additional details were provided as follows: A medical science liaison (MSL) reported that the patient experienced erythema, stiffness and swelling in the arm after receiving the MENVEO vaccine. On 22nd July 2016, the patient was admitted to the emergency room (ER). The patient was diagnosed with cellulitis. The physician prescribed KEFLEX antibiotic for 10 days. The physician reported that the erythema was in correlation with the MENVEO. Another sales representative also reported this adverse event.
Info has been received from a health professional concerning a 5 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced a very minor breakthrough case of chickenpox. It was unknown if medical attention was sought. Additional info has been requested.
light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient).  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization.  Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications.  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021.  Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Approximately 2am of 01/29/2021 I became very over heated for about one hour. Around 3am I then became incredibly cold and shaking. Around 4am I got out of bed and stood for a few moments, then walked slowly around my room making my way to our bathroom. I noticed my vision was not right, almost like a fisheye affect and I felt dizzy. I made it to our master bathroom and sat down on a chair for a few moments before I completely passed out. I fell forward, face first on to the bathroom floor hitting the left side of my head. When I regained my conscious I was weak and shaking and was unable to call out to my husband. I slowly pulled myself up to the toilet trying to make some noise and my husband then came to my aide.  As he talked I noticed his voice sounded much farther away than it really was. I also had a difficult time cognitively answering his questions about how I felt. I was pale, clammy, still shaking. This episode from the time I left my bed from the time my husband walked me back to the bed was about 45 minutes. My husband took my temp and I did not have a fever. The next five hours I alternated between feeling very cold and very hot.  I spent the next 24 hours feeling completely depleted. I rested as much as I could and had a greater than normal appetite.
Post vax, the patient developed a maculopapular erythematous rash with itching on the trunk, upper extremities, face and groin.
Post second vax, four days later, he again experienced cold symptoms with a runny nose and a cough. Treatment included Triaminic.  The information received on 05/16 reported the pt still has some cold symptoms.
About 15 minutes after vaccine, I felt a fever blister pop up on my bottom lip.  Within 5 minutes of that, my mouth filled with a 'metalic' taste( not exactly, but as close as I can get) then the roof of my mouth at the gum line began to 'blister' or become sensitive.   This morning, after taking my synthroid, the entire roof of my mouth is now affected.  My morning coffee seemed to improve it for a bit.  It's not a severe reaction, but one worth reporting. My injection site is tender, but that's not unusual.
patient came down with delta variant after getting both does of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patient came down with delta variant after getting both does of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 COVID-19 (patient came down with delta variant after getting both does of the vaccine). At the time of the report, COVID-19 (patient came down with delta variant after getting both does of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a severe headache, shortness of breath, and lost smell and taste manifested under final diagnosis of COVID-19. However, she was not like "oh! she needs to go to the ER".  No concomitant drugs were reported.  No treatment drugs were reported.  Reporter work at a nursing home where covid-19 cases are surging. Reporter wonder if there is a date set for the approval, also if there is a antibody level range to assure a person is protected still, and whether they should get the available booster from Pfizer or wait for Moderna's.  Reporter mentioned a patient came down with delta variant after getting both does of the vaccine.  Reporter would like to escalate the question about which range of antibody levels that indicates if a person is still protected, because they feel it would make people feel more confident about getting the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains Significant information-New events added-Severe headache, shortness of breath,lost smell,lost taste.; Sender's Comments: This case concerns a female patient of unknown age with no details on previous relevant medical history, who experienced the unexpected event of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the second dose of Spikevax, temporal relationship unknown. The rechallenge is not assessable.  The benefit-risk relationship of Spikevax vaccine is not affected by this report. Very limited information has been provided at this time. Vaccination failure was not captured since exact schedule of vaccination and temporal relationship with COVID-19 are unknown.
Description: Pain in the chest, on the left. A few seconds, a few sensations. Moderate - I noticed it, it was very unusual and unexpected. This does not happen to me usually. It was around 21:30, when I was about to go to sleep.  Treatment: I did not know what to do, sat down on the sofa, waited till it goes away, and then went to bed and slept through the night.  Outcome: it went away, I did not ask for medical help on the next day and resumed my usual activities
Ears ringing , achy , and slightly itchy on the inside .intermittent  Pain shoots to top of my head and tingles/burning sensation under scalp .  Started Wednesday(8/18/2021, two days after second dose) and has progressively gotten worse  or maybe just more annoying . Pcp suggested an antihistamine 8/20/2021 otc and it did not help .
11-20-09 6pm Tired and lethargic. 9-10 pm very tired, hard to move, weighted down. 3am Awaken, went to BR, very dizzy, stomach in knots no N/V cold/hot sweaty and white as a sheet. 11/21/09 Weighted down feeling dissipated around 11:00 am, felt achy. 11/24/09 Phone in today feeling fairly normal still dizzy when getting up fast. Advised to contact physician about getting 3#Hep B.
Patient received vaccines and after leaving the room and going to checkout area patient syncope (pale and felt like fainting). Kept patient sitting down on the floor, gave patient water, took pulse ox, other staff went to get provider from a patient room and checked out patient. Waited till patient felt better about (10-15mins) to get up and sit down in the waiting room, gave patient electrolytes, MA staff waited with patient in the waiting room about another 10mins till skin color came back and felt better to leave.
Information has been received from a physician concerning a female who was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced break out of acne around the injection site. The patient sought unspecified medical attention and her outcome is unknown. Additional information has been requested.