chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suffered arrhythmias after the Moderna vaccine; The patient is emotional and seems quite upset; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Suffered arrhythmias after the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Suffered arrhythmias after the Moderna vaccine) (seriousness criteria hospitalization and medically significant) and FEELING ABNORMAL (The patient is emotional and seems quite upset). At the time of the report, ARRHYTHMIA (Suffered arrhythmias after the Moderna vaccine) and FEELING ABNORMAL (The patient is emotional and seems quite upset) outcome was unknown.            Concomitant medication and treatment medications were not reported.  This is a spontaneous case concerning  a female patient of unknown age with no reported medical history, who experienced the unexpected serious (AESI) event of Arrhythmia and non-serious event of feeling abnormal. The events occurred approximately on an unspecified day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Follow up received includes: Event 'feeling bad' added; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age with no reported medical history, who experienced the unexpected serious (AESI) event of Arrhythmia and non-serious event of feeling abnormal. The events occurred approximately on an unspecified day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Nausea, vomiting, dizziness, weakness, feeling like going to black out, migraine, sharp pains in head, legs, ankles, fever, chills-rest
Mother misinformed on the form of the child's birthday as.  We even asked the mom how old he was.  It was not until we uploaded his information to immunization registry later that day did we find out that his actual birthday was, making him 4 years old.  Mother misinformed us in order to get her son a dose of pediatric Pfizer.
Patient called center and reported swelling 3cm below his armpit that appeared yesterday 24h s/p his 1st Pfizer dose.   He has a prior hx of COVID-19 infection.  The swollen area is approx 2-3"" in diameter, mild discomfort when touched or when moving arm, no fever, no change in color or warmness to touch, skin intact.   No visible change in size or pain level over the past 24 hours.  RN told client that it is not a known SE and that immediate eval is not needed unless his condition changes.   RN advised him to use ice and cold compresses for relief and to outline the area with a marker to allow him to gauge if it increases or decreases in size.   RN advised him to go to a UCC or ED if it suddenly gets larger, fever of over 100.4 develops or pain increases in intensity.    Pt has a phone appointment scheduled with his outside PCP 4/23/21 to discuss his concerns.
Itchy patches of discomfort/misery; after adjusting variables, pt has decided started right after and must be due to immunization. Will now try hydrocortisone and BENARYL cream.
On 10/12/06 noted quarter size redness, swelling around 9:30am, did not want his shirt on, arm hurt, clothing irritated him. Shirt on at 2pm off at 9pm, mother seen swelling, redness, heat from shoulder down to the elbow. Able to move arm. Advice Benadryl 1 1/2 tsp PO Q 8, Ice pack PRN, Motrin 1 1/2 tsp PO Q 8.
COVID 19 Vaccine reaction Pts reports his BP spiked during observation period (within 1 min) for his first  dose of the Pfizer COVID 19 vaccine. BP went 180s/80s. Pt experienced  lightheadedness/dizziness, felt he was floating. Pt wife felt pt was in  distress, pt too 'out of it' per wife to realize how off he actually was . BP returned to baseline with in 1 hour. Pt was unable to drive home.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative from social media  concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total administered, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was diagnosed with the covid-19 infection (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210851820. This report was associated with product quality complaint.; Sender's Comments: V0: 20210852374-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Achy joints and muscles initially and overall fatigue started around 7:00pm the day of the vaccine. The site of the injection in my arm was also sore and a little swollen, and warm to the touch. I went to bed and woke up around 3:00am with chills, feeling cold but also sweating a little, with a low grade fever (99.5F), pain in my joints and muscles (most prominently on my legs) and overall discomfort. I took 600mg of ibuprofen (OTC Motrin) and after about 40 minutes I was able to fall back asleep. This morning (day after injection) I woke up a bit sore and the joint aches came back throughout the day. Temperature is still a bit elevated but it was also a warm day. Now at 9:00pm (day after injection) I felt discomfort in my left arm pit and I feel a bump there, maybe the lymph node is a bit swollen. I plan to take some ibuprofen before going to sleep. I should specify that this is my first Moderna dose but I tested positive for COVID back in April of 2020 and got very similar symptoms for about 12 days plus a runny nose, burning nostrils a and a complete loss of smell and taste for about a month.
pt felt nauseous had vomiting;h/a & dizziness x 3days; also c/o mild local react 3x3cm area induration & erythema @ inj site;+ TTP;mildly hypertensive;similar react 1st vax;recommended pt pre-med w/motrin 3 days prior to vax & benadryl
PATIENT RECEIVED A THIRD DOSE OF MODERNA COVID-19 VACCINE AFTER COMPLETING AN ATTESTATION FOR ADDITIONAL DOSE TO DETERMINE ELIGIBILITY. DATE OF FIRST DOSE WAS 02/25/2021. DATE OF SECOND DOSE WAS 03/25/2021. DATE OF THIRD DOSE WAS 08/17/2021. PATIENT CURRENTLY HAS NO ADVERSE REACTION. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine to allow an additional dose to be administered to people who are moderately or severely immunocompromised following a primary mRNA vaccine series but it has not been approved by the ACIP at this time. The covid support hotline suggested reporting the incident to VAERS.
Pregnant at the time of vaccination, 8 weeks. Very first ever pregnancy, no history of miscarriage or abortion. Heartbeat detected via ultrasound 36 hours prior to shot on 6-28-21 at OBGYN appointment. Covid shot taken on Wednesday 7-1-21, Miscarriage occured on 7-3-21. Confirmed loss of pregnancy via ER visit due to bleeding and cramps from ultrasound. Please do more research for 1st trimester before clearing pregnant women as safe to take COVID-19 vaccination. Please add my information to any existing data regarding 1st trimester loss of pregnancy.
09/02/2013 @ 7:00 pm 4 y/o male brought by mother for after-hours visit for c/o leg swelling and rash. Noticed yesterday this morning worse.  At first thought perhaps due to bug bites since had been outdoors for a while at night.  However, continued to get worse today. Mother called me this am and I had discussed option of OTC Benadryl.  She gave him children's allergy relief today--helped with itching; however swelling and bumps seemed to get worse bumps and swelling c/o itching and now with c/o pain. Advised to give regular doses of diphenhydramine at 12.5mg q6 hr for today and tomorrow at least.    Discussed s/s to watch for for worsening, and emphasized to call/f/u if sxs persist or worsen.  PrednisoLONE oral syrup 15 mg/5 mL 5mL po bid x5 days (start date: 09/02/2013). Prescription: qty 50 of 15 mg/5 mL  5mL po bid x5 days  (NO refills).
Pain in arm (unable to lift it high), extreme pain (as of this date I still have this pain, Vomit 3x on 10/06/06, diarrhea on 10/06/06.
Client stated he felt he had a fever over the weekend but did not take his temperature. Swelling present in R upper arm down elbow and complaints of pain in right arm. Stated he can feels discomfort in his neck on the right side. Complaint that he has difficulty swallowing. Client sent to ER by APRN.  Client went to hospital.
reaction to the vaccine shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the vaccine shot) 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.    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 VACCINATION COMPLICATION (reaction to the vaccine shot). At the time of the report, VACCINATION COMPLICATION (reaction to the vaccine shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Reporter's Comments: Unspecified adverse event
This spontaneous report was received from a healthcare worker (pharmaceutical salesman) via another company's representative, concerning to a female patient of unknown age. The patient's concurrent and historical conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength reported as INJ 25/0/5 Y) (lot number, expiration date, dose, route and anatomical location were not provided. The patient's concomitant medications were unspecified. On an unknown date, the patient experienced an unspecified allergic reaction after receiving a PNEUMOVAX 23. At the time of the report, the outcome of hypersensitivity was unknown. Additional information has been requested.
swollen below the injection site; really sore; itchiness; chills; fever up to 100.5 ° F; body aches; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Depression, Hypertension and Muscular pain. Concomitant products included MUSCLE RELAXANTS from 11-Jan-2021 to an unknown date, ANTIHYPERTENSIVES, ANXIOLYTICS and ESTRADIOL.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea). On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen below the injection site), VACCINATION SITE PAIN (really sore) and INJECTION SITE PRURITUS (itchiness). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 12-Jan-2021 at an unspecified dose and frequency. On 13-Jan-2021, CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) had resolved. On 21-Jan-2021, VACCINATION SITE SWELLING (swollen below the injection site), VACCINATION SITE PAIN (really sore) and INJECTION SITE PRURITUS (itchiness) had resolved. Not Provided      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.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots, he/she was sick a few days but hopefully he/she would not got shingles. Additional supportive information: The follow-up could not be possible as no contact details were available.
Lt arm with 14 x 11 area of redness/indurated, circumference of affected arm 24.5 cm . Rt unaffected arm circumference 23.5 cm. No tenderness or fever at 11/11/11 clinic visit. C/o pain at 11/13/11 ER visit. Clindamycin prescribed at ER.
This initial spontaneous case, was received from other health care professional on 02-Nov-2017, concerning a 61-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 31-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 195250, expiry date: 30-Jun-2018). On the same day, after vaccination, patient had an allergic reaction to FLUCELVAX, few minutes later developed a large lump in the area. On 02-Nov-2017, the patient developed bruise where vaccine was administered, rash all over the left side of his body (down left side from left shoulder to left hip as reported). The reporter stated that the lump and bruise was due to hitting an artery there, she did not think that was related to the vaccine. From the symptoms, it was considered as allergic reaction due to the vaccine. The patient was on cold compression as a treatment approximately for 40 minutes for initial lump at the site of injection. From the symptoms, it was considered as allergic reaction due to the vaccine. The rash resolved within one week, but the patient had dry scaly skin where the rash was. The patient was doing fine now. The lump and bruise had also gone away. The reporter considered the causality of the events lump and bruise as not related. The reporter assessed this case as non-serious. Follow up received from the reporter on 29-Nov-2017: Updated outcome of the events injection site lump, bruise and rash generalized, added reporter's comment. Accordingly, updated narrative.
Patient had her flu shot on 10/05/2017. On 10/5/17 there was the normal pain of a flu shot, but no other symptoms. Patient is having sorness/pain in her left arm starting on 10/29/17. She states it is painful to lift her arm up. She stated she has had no redness or swelling at anytime. She has taken 1 dose of ibuprofen.
pt recv vax & pt exp failure to seroconvert;ELISA showed titer to be 0.3;
Vaccine was placed in refrigerator on 4-Nov and was administered on 9-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 4-Nov and was administered on 9-Nov-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 4-Nov and was administered on 9-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 4-Nov and was administered on 9-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No adverse events reported. No temperature excursion of the product was reported. It was reported that vaccine was placed in refrigerator on 04-Nov. No treatment medications were reported.
I had a low fever, aches and chills.  I also had a stuffy cough and sick to my stomach.  About two days of those symptoms, I was feeling better.  I had a problem with my feet hurting about 10 days later.  They got worse and I also had swelling in my feet.  I went to the doctor in August, and they sent me the rheumatologist.  They could not find anything.  I went back to the neurologist in January.  They diagnosed me with small neuropathy I was able to walk with some pain, but now I have to use a cane to walk.  I continue to get worse.
Parent called afternoon of 3/14/03; states child's right arm red, hot, swollen from shoulder to elbow. Took child to MD; antibiotics (Keflex) prescribed. Over the weekend, child in hospital, given steroids related to arm which formed blisters. Blisters now popped 3/17/03, itches. Child better parent reports.
I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 6/29/2021 FEMALE BREAST INFILTRATING DUCTAL CARCINOMA, UNSPECIFIED SITE OF RIGHT BREAST J96.00 ACUTE RESPIRATORY FAILURE 6/2/2021 FEMALE BREAST INFILTRATING DUCTAL CARCINOMA, UNSPECIFIED SITE OF RIGHT BREAST J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2021 FEMALE BREAST INFILTRATING DUCTAL CARCINOMA, UNSPECIFIED SITE OF RIGHT BREAST
muscle pain all over my body; chills; feel the lump in the same area/left armpit; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 11Jan2021 13:00 (1PM) at a single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior to vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies.  The patient had first dose of bnt162b2 for covid-19 immunization on 21Dec2020, 03:30 PM, in the left arm (number and expiry date not reported) and after the administration of the vaccine, patient discovered a lump on the bottom of the left armpit; felt a lot of discomfort when touching it and it went away around 02Jan2021. Post vaccination, patient was tested for Covid as nasal swab on 07Jan2021 with result as negative. When the second vaccine was administered, patient felt muscle pain all over her body, chills and started to feel the lump in the same area (left armpit) the day after the vaccine was administered (12Jan2021). No treatments received in response to the events reported. The patient did not recover from the events muscle pain all over her body, chills, and lump in the same area (left armpit).   Information on Lot/Batch number has been requested.
Soreness and pain in the muscle at the injection site 3 weeks after received shot.  Initially hurt for 3 days after injection then felt better.
20 minutes after Pfizer 1st dose on 3/31/2021,  symptoms of Bells Palsy with twitching, numbness, and tingling.  As of this writing 4/6/2021 symptoms persist.  Patient had only previous instance of Bells Palsy in April 2014 which completely resolved a month later with no lasting effects at that time.
pt states that her right arm became red, swollen and itchy below the injection site. pt states the it is growing every day.  Today 3/11/2021 it measures 10cm but is still growing in size and starting to go around the arm.  Pt has taken ibuprofen and waiting on a CB from her PCP.
Pt called c/o of arm -sore-swollen at injection site, fever. Red and hot to touch.
Information has been received from a registered nurse concerning a 60 year old female who on 23-FEB-2010 was inadvertently vaccinated with a first single 2.5ml dose of PNEUMOVAX 23, SC in the left upper arm. The patient experienced no adverse effect. Follow up information has been received from a physician concerning a 60 year old female with no illness at time of vaccination and no drug allergies, who on 23-FEB-2010 at 8:30 AM was vaccinated with a dose of PNEUMOVAX 23 (lot # 665300/1314Y, IM (previously reported as SC) in the left deltoid, and a dose of ZOSTAVAX (Merck) (lot # 663881/0197Y, SC) in the right arm on 23-FEB-2010 at 8:30 AM. On 25-FEB-2010 the patient experienced mild redness, soreness and bruising at site. On 04-MAR-2010, the patient recovered. No further information is available.
Headaches; body aches.; This is a spontaneous report received from a non-contactable consumer (patient). A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number el3248), via an unspecified route of administration on arm left on 05Feb2021 08:00 AM as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number= EL3248; administration time= 03:45 PM; vaccine location= Right arm) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headaches and body aches on 06Feb2021. The patient did not receive any treatment for the events. The events were assessed as non-serious by the reporter. The patient was not Covid-positive prior vaccination, and the test was not performed post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
patient stated started getting rash 10/23 two days after vaccine. area at rash is sore, rash starting moving down the arm
After receiving immunizations pt had c/o itching, sore throat, vomiting. EMS noted wheezing and transported pt to ER.
This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. The reporter noted that the patient had received their second dose of GARDASIL (strength, dose and lot number were not reported) on an unspecified date. On 11-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (strength, dose and lot number were not reported) to complete the vaccine series. This third dose is being administered outside of the prescribing information. No adverse effect was reported. Additional information has been requested.