chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling (hardness) - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site) outcome was unknown. 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.
She got her vaccine, around 1:30 PM her arm felt like a knife had gone through it, and her heart started beating faster, and erraitically.  She got into her living room and then woke up 2 hours later.  Her arm stayed swollen and not able to use if for 4 days.  After 4 hours her heart rhythm normalized.  She called the pharmacist and told him what had happened, and told him that she will not take the 2nd shot, and he commented that she should not get the 2nd vaccine and gave her our phone # to report the reaction.  She seems to be OK now.    She has strong reactions to a lot of medications and has reactions to many medications.
Hard to the touch; Redness at the injection site /Redness 7 inches long/Redness 5 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Redness at the injection site /Redness 7 inches long/Redness 5 inches wide) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and FOLIC ACID for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Redness at the injection site /Redness 7 inches long/Redness 5 inches wide). At the time of the report, VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Redness at the injection site /Redness 7 inches long/Redness 5 inches wide) had resolved.            No treatment information was provided.   Patient's concomitant drugs included medications for Depression, Blood pressure, Gastric reflux meds and Inhaler.  Patient had a second dose event redness at the site which had recovered after a week.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021. The second dose details were added and event outcome was changed to recovered.
He c/o swollen, painful, arm after the recent penumovax vaccine associated with his arm feeling hot to touch, facial swelling, body aches, chills, fever 102F for 5 days.
23mins post vaccination pt started having tightness in mouth,itchy eyes, facial swelling and itching in upper extremeties.   @16:37 Pt c/o throat sensation, no SOB @16:42 NO Resp distress @16:47 c/o face itching and several areas of urticaria @16:50 MD notified and pt given Epi 0.3mg IM to R thigh @16:55 Benadryl 25mg IM to R deltoid and EMS called @17:02 EMS arrived @17:10 Pt comforatble and leaving vaccination site by Ambulance VItals: @16:42 BP 118/68, HR 61, RR 16, O2Sat 99% RA -- > @16:47 115/74, 69, 16, 100%  -- > @16:51 115/74, 69, 16, 100% -- > @16:55 116/68, 62, 16, 99% -- > @17:02 116/68, 62, 16, 100%RA -- > @17:10 120/74, 79, 100% RA  In the ED pt states that she has been having allergy symptoms on a chronic basis and has been worked up without obvious cause.  No SOB reported.  Pt was not symptomatic and released from the ED after observation. On 10/21, pt presented to the ED again w/ left arm swelling where she got the shot, heaviness on her left eye and started to have heaviness on her jaw. Pt able to swallow, denies SOB. Per ED provider note, "The patient has developed progressively worsening left shoulder swelling and pain that radiates down her left arm.  The patient notes a tingling that is going up the neck and the face.  She notes no weakness there is no shortness of breath.  The onset of symptoms was gradual and symptoms are moderate.  Patient spoke with the advice nurse and was referred to the emergency department. There is no chest pain or shortness of breath no fevers no chills." VSS BP 124/72, HR 90, Temp 97.7, RR 17, O2Sat 99% Pt stable and released from the ED.
Changes in his thinking process/Cloudiness; Feeling cloudy; Severely depressed; Arm swelled; Jerking in sleep; Sick/hurting; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled) and MYOCLONUS (Jerking in sleep) in a 46-year-old male patient 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 was provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled), MYOCLONUS (Jerking in sleep), ILLNESS (Sick/hurting), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN for Body temperature, at an unspecified dose and frequency. At the time of the report, THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled), MYOCLONUS (Jerking in sleep), ILLNESS (Sick/hurting), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory data was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-235660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant Follow up. Added cross link case of dose 1. Patients picture received.
Mole surgery for possible skin cancer in the face.; This is a spontaneous report from a Pfizer sponsored program from a contactable  consumer (patient)   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated that she will be having a procedure (mole surgery) tomorrow (on 19Mar2021) for possible skin cancer in the face. She wanted to know if that is okay or wait after taking her second dose. The first dose was given on 02Mar2021. She was scheduled to have her second dose on 23Mar2021.The outcome of the event was unknown  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
patient stayed for 15 minutes after the shot and then left. She said she tasted metallic and tingle in lips/mouth so she drove back to the store and came inside. We gave her 50mg diphenhydramine PO. She had BP of 178/96 and pulse 107.  She seemed to calm down but we had already called paramedics. They arrived and she became frantic and asked for EpiPen. They monitored her EKG and asked her many questions. She demanded to go to the ER so they put her on a stretcher and left.  Her pulse did get up to 150 when she was most frantic however her oxygen saturation stayed 100% through entire time. She was instructed to slow her breathing and remain calm.
Patient was registered and it was not noted he was 15.5 yrs old.  He was given the vaccine.  At the time of the vaccine, children under 16 were not eligible under the EUA.
PFizer vaccine was administered after being discovered that the vaccines were in the freezer for 11 days longer than the two week standard time.
Whole body skin rash. Red inflammation that looks like sunburn, no raises bumps, but very itchy when untreated. Occurs randomly on different body parts/areas and goes away with over the counter antihistamines Allegra and Claritin. Worst rash happens after taking a hot shower. Started 12/23/2021 and has continued through 01/15/2022.
a couple red marks across; sharp headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a couple red marks across) and HEADACHE (sharp headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031720A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Dermatitis allergic (surgical tape).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (a couple red marks across) and HEADACHE (sharp headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 500 milligram. At the time of the report, ERYTHEMA (a couple red marks across) and HEADACHE (sharp headache) had not resolved.        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.   Patient used cholesterol medicine as a Concomitant medication. Patient used aspirin Bayer back and body 500mg as a Treatment medication.
Expired ADACEL vaccine was given to a patient, No AE; The expiration date was mixed up and thought it wiill expire in 2022, No Ae; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional.  This case involves patient (age and gender unknown) who on 07-Aug-2020 was administered with the dose of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported and expiry date 22-Jun-2020) via unknown route at unknown administration site for prophylactic vaccination as the expiration date was mixed up and thought it would expire in 2022 (expired product administered and product label confusion).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided   It was a case of actual medication error due to expired vaccine used and expiration date format confusion.  At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB were administered after a temperature excursion; This spontaneous report was received from a Certified Medical Assistant (C.M.A.) concerning to a 20-month-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. Her birth weight was 4.16 kg.  On 01-DEC-2022, improperly stored vaccine doses underwent a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes at storage in clinical practice. The temperature excursion occurred as a result of a reading from a Digital Data Logger.  On 20-DEC-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), second dose, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly on the left thigh; and hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, third dose, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly on the right thigh. Both vaccines were administered as prophylaxis (product storage error).  It was also reported that vaccines were administered by a healthcare professional trained, and the vaccines/device were used according to the instruction leaflet.  No adverse event was reported. There was not a product quality complaint.  This was one of several reports received from the same reporter.
Had a big lump; Red; Very sore; Very warm to the touch; It is starting to get itchy; Looks like a rash; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch) and PRURITUS (It is starting to get itchy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch), PRURITUS (It is starting to get itchy) and RASH (Looks like a rash). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MASS (Had a big lump), ERYTHEMA (Red), PAIN (Very sore), FEELING HOT (Very warm to the touch), PRURITUS (It is starting to get itchy) and RASH (Looks like a rash) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.
12/13/2022 in the evening I noticed head congestion, fatigue, and sore throat. 12/14 tested with an at home COVID-19 test positive. Saw Dr. that day, prescribed PAXLOVID and treat symptomatically. Symptoms were worse on 12/14, fever 102. Symptoms tapered off the next couple of days. Felt much better by 12/17. Returned to work 12/19. 12/19 was last dose of PAXLOVID. 12/21 symptoms of congestion, fatigue, and sinus pressure returned and are being treated symptomatically. 12/22 tested positive on at home Covid-19 test. This is where participant was at time of reporting.
Friday 9/13/19 woke up in AM torso was covered in a Rash. not itchy - PT had Fever (didn't take temp) Skin was sensitive had a bad headache. on Sunday Rash was gone. Headache gone on SAT. 9/14. Patient recovered.
pt recv vax in 1996 & late NOV96 pt was pregnant, titer revealed that failed to seroconvert;
tested for covid-19 and the test was positive; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received the 1st dose of the vaccine and then 3 days later tested for Covid-19. The patient's husband stated his wife got the first dose last Tuesday, then clarified and stated it was two weeks ago. Then after the first dose, three days later on an unspecified date in 2021, she got covid-19. He further clarified and confirmed after the vaccine she went to a lab, was tested for covid-19 and the test was positive. Now it has been 15-16 days since, he stated she passed, but clarified 'she passed' as she is okay. Right now, she is doing okay. He stated patient is scheduled for the second dose and he has questions. The second dose is scheduled for 03 Aug2021. He does not know what he should do. He wants to know if she should get the second dose and when she should get the second dose. The outcome of the event was recovered in 2021.
Patient was admitted to hospital on 3/27/21. It was discovered he did not get his second Moderna Vaccine and it was beyond 42 days. since he had the vaccine. His first Moderna Vaccine was given on 2/11/21. On 3/30/21 the second dose of the Moderna Vaccine was given here at hospital. He began to have symptoms that at first seemed like a  normal but severe reaction to the vaccine including, fever and myalgias.  His labs showed neutropenia. He tested positive for COVID-19 on 4/3. It was determined he had Covid-19.   While this is not truly a reaction to or caused by the second vaccine we considered this was good information to make known. Patient who had one dose of Moderna vaccine contracted Covid. His symptoms are mild and he is improving. He has several comorbidities that put him at risk. We moved him to  an isolation negative pressure room and we continue to monitor.
Incredible osteoarthritis pain in arms, hands, shoulders, neck and upper back, hips  (not experienced before receiving the vaccination.)
Headache, Myalgia, Fever, Fatique Narrative:  Employee health notified  Other Relevant History:
Sweating, dizziness, trouble breathing, chest pain, confusion, neck pain, pneumonia, collapsed lung, blood clots in lung, shaking of body.
Edema, erythema, induration from the site of injection on the lateral mid third of the right thigh and progressed the next day to the pubic area involving also her right side vulva, inguinal area.
The RN assigned to work this clinic administered 1mL of the Moderna vaccine as opposed to 0.5mL. Office attempted to reach this patient, via phone, to notify the patient and inquire about symptoms. Patient was left a voicemail and a return phone call was requested. Unable to contact patient via email as email address was not listed.
This spontaneous report as received from a nurse refers to a 23 year old male patient. The nurse reported that on 01-AUG-2014 and 05-AUG-2014, the patient received a pediatric dose of VAQTA (injection, 25/0.5 (unit not reported) (lot # unknown) (dose/frequency, route unknown). No adverse symptoms were reported. Additional information has been requested.
pt devel GBS initially sx about 3wk p/vax;severe sx by 9-10wk p/vax required hosp & IV immune globulin & immuno suppressants;pt still under tx;
Pt was dizzy and became diaphoretic, then had a vagal response. Pt was placed on precautionary O2. Pt was extremely hypertensive. Pt seemed to recover. Then after a few minutes became nauseated and started vomiting. 1 minute later pt became completely unresponsive. Pt was transferred to gurney and transported to local ER.
One day after the shot I noticed a hissing in my right ear.  I've had tinnitus before but not this loud.  Ringing and has effected my hearing. I think I've lost hearing now
On May 18, 1999 the pt developed chickenpox with approximately ten lesions. The reporter indicated that only two of the lesions were itchy. The physician confirmed the patients symptom, and believed that there was an association between the pt symptom and vax.
Patient had syncopal episode within 15 minutes of vaccination.  Had history of similar episodes after previous vaccinations.  Patient felt better and was released to home.
Pt recvd Engerix-B 15JUL92, 19AUG91 & 25JAN92 & 31MAR92 titer levels revealed pt had not seroconverted;
Patient was standing to pick out stickers approximately 5 minutes after receiving her 3rd vaccine and she fainted. She fell backwards and hit a chair, getting a gash in the back of her head.
9MAY t102.8, irritable, redness @ rt thigh & buttocks;appetite poor;
The case was received on 21 March 2014. Initial misuse report received from a healthcare professional on 17 September 2013. A patient had received a dose of FLUZONE and a dose of FLUMIST on an unspecified date. It was reported that the patient was administered FLUMIST and FLUZONE instead of GARDASIL. No adverse event was reported. List of documents held by sender: none
Muscle knot at location of shot developed 24 hours after receiving vaccine. 48 hours after shot developed bruising. 96 hours after shot arm pit has become swollen and swore. 96 hours till current date/time of 6 days later swelling and soreness to arm pit progressively getting worse.
The day after the vaccine I noticed petechiae on both feet and lower legs. I emailed my doctor who was not able to provide. It has lightened up but still there.
Two weeks after taking the third dose, I developed a Chronic  allergy all over my body that cannot be removed with any medication.
This spontaneous report was received from a registered nurse regarding a 20 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II  lot # N013868, expiration date 04-MAY-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000142:
Chills, Muscle and joint pain, Loss of Appetite, Extreme fatigue, headache and fever (up to 103.5 even when on Advil). Had low grade fever up till 4 days after vaccine  Fatigue has persisted a week later