chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UTI; BV; Short of Breath; Weakness; Rapid heart rate; HgbA1C up to 7.8; Hives; rash; Itching; Swelling; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), URTICARIA (Hives), RASH (rash) and PRURITUS (Itching) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced URTICARIA (Hives), RASH (rash), PRURITUS (Itching) and SWELLING (Swelling). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8). On 30-Mar-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PRURITUS (Itching), SWELLING (Swelling), URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
12/12/2022 I  went to my GP for a regular check up as I have lumbar radiculopathy and was prescribed a course of  prednisone  and muscle relaxers.  On 01/01/2023 I called the physician because I was feeling very sick,  I was weak and tired,had a low grade headache with a little bit of fever and shivering with chills for about 6 days. I was prescribed antibiotics after the 6th day and I'm feeling a lot better now.
Patient presented to our health dept COVID 19 vaccine clinic requesting Moderna Booster vaccine.  None of the staff assessed to recognize that he was not eligible at age 17 years.  His primary series was Pfizer.  He received an unauthorized Moderna Booster at age 17
Bad allergic reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a bad allergic reaction.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced a bad allergic reaction. Treatment for the event included epinephrine injection.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, experienced a bad allergic reaction, was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of hypersensitivity.  The event of hypersensitivity occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. She was treated with EpiPen. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded.
Pain running down in his left arm where he got the shot from his neck to his shoulder; Pain running down in his left arm where he got the shot from his neck to his shoulder; Pain running down in his left arm where he got the shot from his neck to his shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), outcome "not recovered" and all described as "Pain running down in his left arm where he got the shot from his neck to his shoulder". Therapeutic measures were taken as a result of arthralgia, vaccination site pain, neck pain which included Tylenol.  Additional information:The patient that he just his second dose of the vaccine on withheld and 2.5-3 weeks later that there was pain running down in his left arm where he got the shot from his neck to his shoulder. He was taking Tylenol for a few days and it didn't help. He will be seeing his doctor. He thought that he slept wrong on his neck but that wasn't it since that usually resolved in a few hours. He wanted to know if they had any of same issues with this problem was for the Pfizer Coronavirus vaccine. He Wanted to know if there were different Pfizer vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt called clinic 9/8/16 to report that had fever 9/2/16-9/3/16, body aches and weakness. Starting with arms and shoulders spreading to entire body, not able to get out of bed; feeling better today able to be up.
Dizziness, Fever, Chills, Diarrhea, Muscle Aches, Headache; Large, Hot, Red, Raised area (circle) around vaccination site. Started with Dizziness around 7 am on 11/5/21; progressed to a 102.3 fever, chills, and headache lasting until 11am on 11/6/21. Unable to continue daily activities, had to stay in bed.
Discomfort at shot site, fatigue, aches, sour stomach, headache, congestion, runny nose.  Symptoms were strong day of shot and day 2.  Day 3 symptoms 50% milder. No symptoms day 4.
Left arm extremely weak, muscle wasting, red ring around injection site, left arm bruise for 7 weeks, very painful aching sensation from 9/21/2018 to present - aching has subsided but is still present, arm remains weak.
Large (10 cm) erythematous, warm and painful skin reaction 10/15/19 resolved over 5-7 days Severe myalgias, arthralgias, fatigue, chest pain, night sweats, headaches, brain fog peaking 10/19 and 10/20 that lasted 3-4 weeks Required ibuprofen 400 mg daily X 5 days to function Seen by a rheumatology colleague
Information has been received from a physician concerning a 9 week old male who on 22-FEB-2007 was vaccinated with his first oral dose of Rotateq. on 23-FEB-2007 the patient was splitting up and vomiting, followed by an increased mark of emesis on 25-FEB-2007. No medical attention was sought. Subsequently, the patient recovered. The patient was not given the other two doses of Rotateq. There was no product quality complaint. Additional information has been requested.
lt arm became swollen, red & hot to touch p/DTAP;appeared @ inj, now more swollen;no fever, no pain elsewhere in body;area on lt arm is tender to touch seen by pvt MD & placed on ATB;
Pt exp h/a, bad taste, difficulty swallowing, rapid, shallow breathing; shivering, tongue paralyzed; tx Epi, DPH; BP 156/110, 200/110;
This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-DEC-2015, the patient was inadvertently vaccinated with an additional 0.5 ml dose of VARIVAX (Merck) (lot # was not provided; subcutaneously) concomitant with second 0.5 ml dose in VARIVAX (Merck) immunization series. No adverse effects were reported. Additional information has been requested.
Presented on 7/24/06 with c/o n/v, dizziness, fever, achiness x 24 hours. Diagnosed as vaccine reaction vs. acute viral syndrome. Quarters x 24 hours and push fluids. Tylenol prn.
Within 1 hour sore arm around injection site. 3am 3/5/21 body aches all over (significant), headache, chills, felt feverish never registered a fever, treated with Tylenol, symptoms continued all day along with tiredness and symptoms became strong when Tylenol was wearing off each time, continued taking Tylenol all day. 5pm diarrhea began. Woke up during night 3/5 to 3/6 cold sweats but feeling better. 530am 3/6 feeling better headache, sore arm, some cold sweats as if I broke a fever. By 8am 3/6 completely recovered. Slightly sore arm otherwise no symptoms.
2 days after receiving first dose Pfizer Covid-19 vaccination, developed vaginal bleeding that has persisted for 10 days. Is on birth control pills and has been taking regularly. Bleeding described as darker red in color and flow about same as first day of normal cycle. Is on 3rd week of active pills.  Urine pregnancy test done 4/20/2021 negative. Checking CBC today.
Cellulitis and bruising at injection site. Headache, chills, and joint pain after shot.
Initial unsolicited report received consumer on 25 March 2015. A patient, whose gender, medical history and concomitant medications were not reported, had received a dose of DAPTACEL (batch number, dose, cycle in series, route of administration, site of administration were not reported) on 02 March 2015. On an unspecified date, after vaccination, the patient experienced Adverse Reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none.
Paient experienced adverse effect possibly from Afluria flu shot: rash on hands and arms, loose stool, cough and runny nose beginning the day after receiving flu shot.  When she contacted us on 10/04/10 the symptoms of rash were subsiding.  Told patient she could use Benadryl if needed but she felt it was getting better, she just wanted the event reported.
There was no problem day of vaccination after waking up my problem really started. I was in pain for 2 1/2 days. Being in bed at the time for hours even when I got up; I immediately had to apply ice all day to subside the continued pain. After the second day, it slowly subsided.
A delayed, large oval-shared rash at the injection site 10 days after vaccination with redness, itchiness, and mild irritation. Gradually diminished in size and redness in 2 weeks.
I was having a runny nose and a fever. I then took a COVID-19 Home Test and it was positive I then called my healthcare provider, and they got me on Paxlovid. On May 3rd I was still positive but by the 6th it was negative.
an expired dose of Bexsero was administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Bexsero vaccine, which led to expired vaccine used. No further information reported. The reporter consented to follow-up via mail.
Initial information received on 28-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 11-Oct-2017 patient received 0.25 ml dose of FLUZONE QUADRIVALENT with an unknown batch number via unknown route in unknown administration site. On 01-Oct-2018, the patient received a 0.5 ml second dose of same vaccine lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to missed dose. It was unknown whether adverse event occurred. 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.
Patient first received Pfizer Bivalent booster on 09/10/2022 and scheduled an appointment and received a 2nd dose of Pfizer Bivalent on 11/22/2022. Spoke to patient today no adverse events to report.
Abrupt onset weakness left shoulder.  difficulty abducting,  paresthesias of LUE  Gradually 90% resolved in 30 minutes and almost complete resolution at 24h
I experienced constant itching and it will not go away, I will be seeing a doctor 02/17/2022 because of this symptom.
Injection site reaction - small red bump baseball size hard area - sore to touch. Pt also complains of severe leg cramps during night since receiving & increased frequency of urination.
Varicella - Information has been received from a physician concerning a 4 year old patient who on 24 Aug was vaccinated with varicella virus vaccine live.  At the end of April of 2000, the patient developed chickenpox.  It was indicated that this seemed to be a mild case of chickenpox, but the office only saw the patient in the beginning of the breakout.  An additional patient waes 00050771 had a similar experience following exposure to varicella vaccine live.  Additonal information has been requested.
Given vaccine with aseptic technique on 2-10-20 and she had a red "heart shaped" bruise the following morning but no soreness or other issues. On the 3rd day she went to "workout her arms really well" and on the 4th day she said her arm and back were sore and the red bruise had become dark with a large lump under the injection site.
Patient had shallow breathing, started shaking, and she got very cold 2 hours after receiving flu shot.
Pt c/o itchy face, scalp, hair line, trunk & arms with red blotches that became hives. Tx'd w/Benadryl 25mg po x doses.
Headache, Diarrhea, NauseaVomiting, itching Narrative:
patient is 60 years old Caucasian male with past medical history of hypertension and diabetes mellitus came to emergency room complaining of multiple symptoms including fever, chills, cough, shortness of breath and body aches for 1 week.  In emergency room he tested positive for COVID-19 infection and chest x-ray showed picture of pneumonia.
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
Suspicious of cellulitis; Skin reaction that included, swelling; Skin reaction that included, swelling, pain; Skin reaction that included, swelling, pain, redness; Skin reaction that included, swelling, pain, redness and streaks; Injection site reactions presented with red streaks; This case was reported by a physician via sales rep and described the occurrence of cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   In August 2020, the patient received the 2nd dose of Bexsero. In August 2020, 1 day after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim) and antibiotics nos (Antibiotic (Details Unknown)). Rechallenge with Bexsero was positive. On an unknown date, the outcome of the cellulitis, injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion were recovering/resolving.   It was unknown if the reporter considered the cellulitis, injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion to be related to Bexsero.  Addiotional details were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero last week before date of reporting, and experienced cellulitis (serious criteria GSK medically significant), injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion. The reporter stated that, the patient treated with Bactrim sent home with antibiotics and has not contacted the doctor since. The doctor commented that the patient hdas never seen this type of reaction and that this patient never had issues with other vaccines. The reporter consented to follow up. For the tollerence of 1st dose refer case US2020AMR160420, reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160534:FU1 deleted US-GLAXOSMITHKLINE-US2020AMR160420:same reporter
About 3 hours after receiving injection I noticed swelling around the injection site as well as tenderness.  Over the next few hours the tenderness became increasingly painful radiating between my shoulders to my elbow as well as numbness to my nose and cheeks.  I also experienced fatigue.  The pain in my arm interrupted my normal sleeping routine for a couple of nights.  As of 04/16/2021 the swelling and pain in my arm has diminished to the point of being normal.
This spontaneous report has been received from a registered nurse, who reported that unspecified number of patients were administered PEDVAXHIB which underwent supported excursion in December 2013. All telephone attempts to obtain follow-up information had been unsuccessful. This case is linked to 1403USA010165, 1404USA001099, 1404USA001100, 1404USA001102. Additional information has been requested.
I had chills, and low-grade fever of 99. I started feeling better, so I went to work, and I started sneezing and coughing. When I got home on 12/12/2002 I took a COVID-19 test and it was positive. But for the rest of the week, I was fine. On 12/29/2022 I felt cold, fever of 102, and sore throat. I went to the doctor, and they tested me for COVID-19, Flu, and Strep. I was positive for strep.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/3/2021 and 3/2/2021. Patient reportedly COVID positive on 9/8/2021. Patient presented to the emergency department for hypoxia on 9/10/2021 and admitted on 9/11/2021. Patient received: ascorbic acid, methylprednisolone, remdesivir, tocilizumab, and zinc. Patient's respiratory status continued to decline throughout hospitalization. After discussion with family, patient was transitioned to comfort care. Patient expired 9/30/2021 at 1700.
Fever of 103 degrees, severe weakness and body aches approximately four hours after receiving the inactivated influenza vaccine.  Took two Tylenol PMs and went to bed.  Woke up the next morning with no signs of illness.  Called physician's office and was told that it was couldn't be a reaction to the flu shot.  I was told that my white blood count on that day was "normal," but that maybe something was coming on when I received the shot. I replied that by the next morning, I was perfectly fine.  They then told me, "Well, maybe you just shouldn't get the shot, then." I have Multiple Sclerosis, and I am advised by my neurologist to get the shot!  No effort was made to make a report, therefore I am doing it myself...  (after getting online and finding the vaccine information paper from the CDC website.) I was reading the CDC information page on the influeza vaccine again, and I noticed that "hoarseness" was also a potential reaction. I have been very hoarse since the shot, but, at first thought it was due to the weather. However, even when I drink something hot, the hoarseness does not go away, as normal hoarseness usually does. So, I would like to add this to my report. I received the vaccination last Tuesday, and I have been hoarse since.  When can I expec t this to stop? Are the reaction sI experienced from the shot considered an allergy to it? With Multiple Sclerosis, I am supposed to be vaccinated every year, because contracting influenza can be extremely harmful to me. Would this reaction make me unable to be vaccinated, or do the benefits outweigh the risks? (I can handle fever the night of the shot because I can take medication  to alleviate the discomfort and lower the fever, and the hoarseness is only a minor nuisance.) Please respond, because I have four school-aged children who frequently bring illnesses home from school, and I feel more protected being immunized. If I should avoid the flu shot, is there another vaccination I could take that would offer me protection from the flu that is perhaps made up of different components than the one I have been receiving? Any information and advice would be most appreciated. Thank you!
Patient went to a pharmacy and was administered these two vaccines on 10/3/2022 NABP#0425656 ID;FW6217613 NPI# 1891143020 then left the pharmacy and this nurse was told by patient that she experienced itching all over her body and swollen itching throat within 10 minutes of receiving the two. Patient came to our clinic on 10/6/2022 and is still itching and has some swelling to the left upper arm.
Swollen lump just under left collar bone, also a raised line/streak (not red or painful) from site of immunization to swollen lump. 4-5 inch patch of red, sore, leathery skin all around site of immunization, very sore to touch.
Fever, Aches, Shortness of breath/difficulty breathing, Cough Cause of death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID PNEUMONIA
I experienced COVID-19 on 08/02/2022 and was sick for a week. I had first symptoms of COVID. I saw the cardiologist who ordered an echocardiogram on 12/01/2022. The echocardiogram showed pleural effusion.  It also showed pericardio effusion. I do not know what caused the pleural effusions. I had severe pain in my chest, right under my breast bone during COVID. It felt like spasms in the center of my chest.
No additional AE; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant referring to a 54-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 16-SEP-2021, the patient was vaccinated with an improperly stored dose ofvaricella virus vaccine live (oka/merck)(VARIVAX) lot number T032317, expiration date 22-SEP-2022  (dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion between 6 degrees Farhrenheit (°F) and 14°F, with an average of 8.5°F for 18 minutes, and between 6 degrees Farhrenheit (°F) and 14°F, with an average of 11.9°F for 1 hour. No previous temperature excursions reported.
moderate urticarial rash, itchiness, periorbital puffiness, nasal discharge;tx DPH;