chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt Reported Having a Rash on Her Face That Lasts Several Days; This is a spontaneous report from a contactable nurse.   A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 65-years-old) as dose number unknown single for covid-19 immunization, patient received celecoxib (CELEBREX, Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date, at 200 mg for an unspecified indication. Medical history included mild tingling in her lips from Nov2020 to an unknown date, moderate left hip pain from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient reported that she had a rash on her face that lasts several days, patient stated the rash was sometimes on her chin, sometimes appears as a mask under eyes, or on her forehead. MD aware. The clinical outcome of event was not recovered.    Follow-up (02Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Within 24 hours I developed a problem with breathing, I cannot take a deep breath without intense pain in my chest. Sitting or leaning forward causes the pain to get worse. I also have a very very large red splotch that is continuing to get larger since receiving the shot, and that arm /side has intense pain
Severe testicle pain, migraines. Hospitalized for seizure and sleeping disorder. The follow up received on 12/1/03 states testicular swelling. Pt treated with several courses of antibiotics; however, testicular pain and swelling persist. Pt treated x 2 days with Dilantin for seizure. No recurrence to date. No further Anthrax vaccines received.
TROUBLE WITH HER VISION ON HER RIGHT SIDE; NUMBNESS IN RIGHT ARM AND LEG; TINGLING IN RIGHT ARM AND LEG; PRESSURE ON RIGHT SIDE OF HEAD; HEADACHE; PAINFUL ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and pain very rarely in her left leg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced painful arm. On 30-MAY-2021, the subject experienced tingling in right arm and leg. On 30-MAY-2021, the subject experienced pressure on right side of head. On 30-MAY-2021, the subject experienced headache. On 31-MAY-2021, the subject experienced numbness in right arm and leg. On an unspecified date, the subject experienced trouble with her vision on her right side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble with her vision on her right side, and painful arm on 29-MAY-2021, was recovering from headache, and pressure on right side of head, and had not recovered from numbness in right arm and leg, and tingling in right arm and leg. This report was non-serious.
11 years old received Flublok instead of prescribed Fluzone Quadrivalent/ NO AE; 11 years old received Flublok instead of prescribed Fluzone Quadrivalent/ NO AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff).  This case is linked with 2019SA267180, 2019SA267186, 2019SA267188 (same reporter)  This case involves a 11 years 6 months old female patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE , Frequency = once, lot QFAA1903, exp date: 19 May 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the 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  List of documents held by the sender: none
Patient, her mother, father and brother all came for flu shots. The father was also to receive his COVID booster - Pfizer. I had the injections prepared for all of them, but accidently picked up the Pfizer syringe and administered it to the child. I realized my error when I saw the remaining syringes and noted the Pfizer vaccination was missing. I immediately told the mother the error I made and also related this to the clinic nurse practitioner and the father. We monitored the patient for 15 minutes for an allergic reaction, as with all patients who receive a COVID vaccine. the mother chose not to proceed with the flu vaccination for her daughter at this time. Information was also given to the father about signs and symptoms that may normally occur when getting a COVID vaccination. The vaccination will not be approved for this age group until next week. The mother was advised about the need to the second Pfizer dose in 3 weeks.
vasculitis on both legs, lower abdomen, lower back and buttocks; rash; This case was reported by a physician via call center representative and described the occurrence of vasculitis in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 54A2T, expiry date 11th December 2021) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th November 2019, 8 days after receiving Shingrix, the patient experienced vasculitis and rash. On an unknown date, the outcome of the vasculitis was recovering/resolving and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vasculitis and rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient noticed a rash and went to visit the doctor.  The patient had vasculitis on both legs, lower abdomen, lower back and buttocks.  The reporter states that, the vasculitis was resolving, however, it was not completely resolved. The patient required emergency visit.
This spontaneous report as received from a health professional via company representative refers to a patient of unknown age and gender. On 16-AUG-2017, the patient was vaccinated with VARIVAX (lot # L042265). The patient did not receive any other dose after initial exposure date. On an unknown date in 2017, the patient experienced unspecified adverse event. The outcome and causality of the event were unknown. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1709USA011850.
increased heart rate; Dizziness/light headed; This non-serious case was reported by a consumer via sales rep and described the occurrence of dizziness in a 42-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 17-FEB-2023, the patient received the 1st dose of Shingrix (unknown arm). On 17-FEB-2023, less than a day after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness/light headed). On 18-FEB-2023, the patient experienced heart rate increased (Verbatim: increased heart rate). On 18-FEB-2023, the outcome of the heart rate increased was resolved.  On 20-FEB-2023, the outcome of the dizziness was resolved.   The reporter considered the dizziness and heart rate increased to be related to Shingrix.     The company considered the dizziness and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient self-reported this case. From 18th February 2023 to 19th February 2023, the patient experienced lightheaded. The reporter consented to follow up.
Swelling in arm after COVID-19 booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling in arm after COVID-19 booster shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, UNK. In February 2022, the patient experienced VACCINATION SITE SWELLING (Swelling in arm after COVID-19 booster shot). In February 2022, VACCINATION SITE SWELLING (Swelling in arm after COVID-19 booster shot) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was no reasonable possibility. 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.
The vaccine was kept at room temperature for longer than the 6 hour window allowed under the EUA. It was kept at room temperature between 7-7&1/2 hours. We place a note in all of our batches of vaccine that we draw up with the time it expires. The pharmacist missed seeing it, and it was caught when we went to draw up the next vial. We will be in contact with the patient to let them know they need to repeat the dose.
I went to get my second Covid-19 vaccine and when the student nurse went to inject me it ran down my arm onto the table. The shot was only 1/2 mL . It looked like there was more than that on the table. I do not think any of the vaccine went into my arm.  The student nurse went to tell the supervisor what had happened and she came over. She said as long as any of it was administered that i would be protected. I purposely did not take any Tylenol or drink extra water because I wanted to have a reaction to know that I got some vaccine. I have felt totally fine. My arm is not sore. I have absolutely no symptoms that the vaccine may cause. I am convinced the vaccine was left on the table. I went back to the health department on March 22 to report my observations. They told me they could not help me.
Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01Oct2022, outcome "unknown". Additional information: The patient had the Pfizer booster (anatomical site was reported as "Left") on 01Oct2022 and had been feeling dizziness. It started a few hours after that and now it is the next day too. The patient asked if it was a common side effect. The dizziness did not occur within the first hour after getting the vaccine. The patient hasn't received treatment yet.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Hives and red rash on legs; Hives and red rash on legs; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiration date not reported), via an unspecified route of administration (right arm), on 20Jan2021 12:15 at a single dose for COVID-19 immunisation. Medical history included prinzmetal angina, hypothyroidism, and penicillin and sulfa allergies, all from an unknown date. Concomitant medication included diltiazem, estradiol, pantoprazole, and atorvastatin calcium (ATORVAS). On 22Jan2021, the patient had a reaction to her first dose of vaccination, and she was wondering if that would be a problem when she takes the second dose. The reaction she had was some hives and some red rash on her leg and it happened about 48 hours after she got the shot. The patient took Claritin pill and some Anti-Itch SavOn as treatment. Her second dose of vaccine was scheduled 15Feb2021. The patient was recovering from the events.
Dizziness, Myalgia, alternating chills/diaphoresis Narrative:  Immediately after receiving the vaccine, the patient reported feeling dizzy. That night, she woke up several times with what she described as alternating between chills or hot flashes (feeling warm, sweating). Her arm was sore where she received the injection. She did not receive any treatment.  Other Relevant History:
chest pains, shortness or breath, dizziness, feelings of heart attack Went to ER, stayed for 4 days, all tests complete & showed myocarditis Had heart MRI Jan 5 which confirmed myocarditis
Headache worsening after about 6 hours and pain at injection site.  Headache continued during the night, with restlessness, muscle soreness preventing sleep.  Headache continued after getting up around 7 am, with nausea.  Started drinking water, vomited around 10 am.    Ate 2 pretzels, drank ginger ale.  Fever of 99 degrees, chills.  Took tylenol.  Vomited around 2 pm. Tool Emetrol.  Headache worse.  Vomited at  4pm. and again at 6 and 8.  Went to ER at 9.      Vomited 2 more times while waiting.  Given meds for vomiting, pain and IV fluids  around 11:30 pm.
Rash on face, arms, started 11/11/14 in the morning at approximately 6 AM. Went to Dr was put on steriod Prednisone for 6 days.
30 minutes after the shot I got a scratchy throat for about an hour. 4 cough drops and 1 hr latern it  went away. Tuesday evening I felt like I had a bit Of the flu-just like after a flu shot. But Sunday morning  around 8 am in the shower I noticed red bumps on my ankles. These continued to spread up my legs  during the day. A lot of them! I took Zyrtec and in the evening there were more including on the back  upper side of my arms. A lot of them! By Monday morning after a miserable night my lower legs below  the knees to ankles were covered and more on my body. I went to the doctor. Believe this is a reaction  to the Covid 19 shot. Taking two 24-hour a day Zyrtec and using Calamine lotion. Still ongoing 3/11.
Following post vaccine patient felt a pain across he forehead , had throbbing pain and patient was extremely anxious, rapid pulse--patient was taken to medical observation and vital signs obtained , bp was 134/95   pulse 108  @ 11:40 then at 113/78 pulse 94 @ 11:50  patient was able to leave via  the site they were transported to the exit via wheelchair
12 hours after receiving the vaccine woke up with a fever of 103, extreme headache and body aches. Nothing would release fever or pain. Fever lasted 9 hours. Site of injection started to swell within 1 hour, continues to be swollen.  Continues to have body aches and fatigue.
Soreness at first, bruise at injection site October 9th. October 10th, soreness much increased, but could use arm; red rash appeared below injection site. October 11th, increased redness, warmth when touching red area; soreness slightly decreased.  October 12th, still large area of redness, but decreasing in color. October 13th to October 15th, redness much paler.  October 16th, redness appears more like a rash, with some itching and warmth again, but tolerable.
Received vaccine 10/21/13 at 14:00 2:00 PM. 10/23/13 0200 AM, suddenly developed low grade fever, body aches, chest heaviness, head congestion. Symptoms gone after 24 hours.
felt like something was crawling on her arm and she kept brushing it off; felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve; hypertension; Lot of agony; muscle spasm; pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony) and MUSCLE SPASMS (muscle spasm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: flu short in November 2020.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony), MUSCLE SPASMS (muscle spasm) and VACCINATION SITE PAIN (pain at injection arm). At the time of the report, FORMICATION (felt like something was crawling on her arm and she kept brushing it off), VACCINATION SITE DISCOMFORT (felt like she had blood pressure cuff on that arm compressed and release, hard tight, like something gripping in arm, pressure point/they hit a nerve), HYPERTENSION (hypertension), PAIN (Lot of agony), MUSCLE SPASMS (muscle spasm) and VACCINATION SITE PAIN (pain at injection arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. Treatment to the events given as cortisone cream.   This case was linked to MOD-2021-276731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non significant information On 28-Sep-2021: Significant follow-up appended Event added and patient initials updated.
I was feeling good until about 1pm the next day, when I felt as if I had fallin down stairs. About 1 hour later I checked my temp and it was at 101.4, whith chills along with bodyaches and head ache. I then went to bed about 3pm bundling up with chills for about 5 hours before feeling warm. about 2am I check my temp and it was at 102.5. sometime around 5 to 6am I started sweating until my fever was gone. I stayed in bed until about 9am, when I did feel much better. However, as I tried to eat anything on 5-18-2021 it all tasted like SALT. I mean everything was salty. The injection site is very red and warm to the touch as well as hard and brused.
On Sunday, March 14 (8 days after the vaccine), I developed a reaction at the site of the injection.  It was a raised pink, itchy and warm square about 3x4 inches.
Information has been received from a health professional concerning a 20 year old female with a history of drug hypersensitivity to Erythromycin who on 26-JUL-2007 was vaccinated intramuscularly with her first dose of Gardasil (Lot #657006/0188U).  Concomitant therapy included influenza virus vaccine (unspecified), venlafaxine HCl (Effexor) and ethinyl estradiol/norgestimate (Ortho Tri-Cyclen).  On 26-JUL-2007 the patient experienced pain at injection site.  The patient sought unspecified medical treatment while at the office.  On 06-NOV-2007 the patient was intramuscularly vaccinated with the second dose of Gardasil (Lot #659437/1266U) and experienced pain at the injection site.  Subsequently, the patient recovered from the pain at the injection site.  Additional information has been requested.  This is one of several reports received from the same source. This is in follow-up to report (s) previously submitted on 12/14/2007.
I started to have COVID-19 symptoms like lung issues, blood oxygen levels the same as when I had COVID so that was the main issue
Initial unsolicited report received from a Nurse on 20 December 2016. This case involves male (age not reported) patient who was vaccinated with a dose of High Dose Flu Vaccine (batch number, expiration date, dose, site and route of administration was not reported) on 27 October 2016. Patient had medical history of Diabetes. Concomitant medications included insulin injection on an unknown date. On an unknown date, following the vaccination, the patient was tested positive to a recent HIV test. It was reported that "insulin injection was given to patient by a staff member at the facility recently and after the injection, the staff member accidentally stuck themselves with the needle." Both the patient and the staff members were tested for HIV and the patient had a positive result. The administrator had been told that false positive HIV test results were possible in patients who received a flu vaccine. Other Lab data was not reported. Corrective treatment was not reported. List of documents held by sender: none.
17FEB99 productive cough, nasal drainage, inc temp sudafed, APAP, augmentin;flu dx;