chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUZONE QUADRIVALENT (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event.; FLUZONE QUADRIVALENT (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event.; Initial information was received on 10-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 33 years old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event. while receiving vaccine .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Nov-2023, the patient received 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection (lot U8192CAand expiry 30-06-24) (strength: unknown) via intramuscular route in the left arm for immunization.  On 09-NOV-2023 the patient developed a non-serious fluzone quadrivalent (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event. (incorrect dose administered and exposure via skin contact) (latency same day).  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 the 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.
Three weeks after getting the second dose I got a rash on my face. It was there for about a month and it spread over my whole face. Sometimes it became blisters. It was itchy, red and sore. I could not use any cosmetics. The sun made the rash worse and the skin was very sensitive. I tried some hydrocortisone cream and it was soothing but did not help. The doctor prescribed Ointment but it did not help. It has been six months and I still have the rash. It is a little better but it is still all over my face. There was a little on my body, but it is not much. It is still itchy and sometimes painful. The rash is in big patches or little spots on my cheeks, the bridge of my nose and my eyelids. I can't use any chemicals of any kind or it becomes worse and very painful.
Woke Friday morning with large mass left armpit.  About the size of a tennis ball.  Sore to touch.  It is now Sunday afternoon and size has started to decrease slightly.  Soreness has went away. Have taken ibuprofen and staying hydrated.
1/22/21 1300;  2/23/21 1300; Moderna 029L20A(#1), 13M20A(#2) redness and itching at injection site; warm to touch
Dizziness, Headache, Myalgia, Arthralgia, Fever & NauseaVomiting  Narrative:
Information has been received from a physician concerning a 17 year old female with a positive family history of seizure within the family and who was vaccinated with Gardasil on her right arm. There was no concomitant medication. After being vaccinated with Gardasil, the patient was dizzy, passed out and had a tonic clonic seizure. The seizure lasted 2-3 minutes long and had urinary continence afterward. Unspecified medical attention was sought and the patient's blood pressure was 100/70, her pulse was 120 and the physician did a respiratory rate, which was 25. The patient was also sent for an electroencephalography (EEG) (results not provided). As of 22-AUG-2007, the patient was recovering from dizziness, increased heart rate, passing out and her tonic clonic seizure. Product Quality Complaints (PQC) were not involved. Upon internal review, tonic clonic seizure was determined to be an other important medical event. Additional information has been requested.
flu like symptoms; chills / started 2-3 after the vaccine injection / it has not stopped but it has eased up. Chill symptoms are at a low level but had not stopped.; having diarrhea / started 2-3 after the vaccine injection / it has not stopped but it has eased up; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced influenza-like symptoms, chills, diarrhea and upset stomach. On an unknown date, the outcome of the influenza-like symptoms and upset stomach were unknown and the outcome of the chills and diarrhea were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, chills, diarrhea and upset stomach to be related to Shingrix.  Additional details were provided as follow: The case was reported by patient for herself. The patient had received 1st dose of Shingrix on an unknown date. The batch number and expiration date were not provided. Patient does not recall the date that she got the vaccine and does not know in which arm it was injected. The patient reported that she had Pneumonia vaccine on the same date. The patient stated that she continued having diarrhea, chills, flu like symptoms and upset stomach.  The  patient reported  that the diarrhea and chills started 2-3 after the vaccine injection.  The patient stated it had not stopped but it had eased up.  Chill symptoms are at a low level but had not stopped. Patient did not provide consent to follow up with healthcare professional until she had her appointment first. It was unknown if the reporter considered the influenza-like symptoms, chills, diarrhea and upset stomach to be related to PNEUMONIA VACCINE.
Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the next day with a fever at 5pm of 100.5;  Sunday no temperature but loss of taste, diarrhea, stomach discomfort.
c/o lightheaded ness & heart palpitations for min.  post injection.  h/o increased BP;  no meds taken this AM.  Symptom quickly improved with mask removal & fresh air.  Reported most likely R/T anxiety.  On recheck - reported symptoms resolved.  BP 130/86;  HR 86; drove off  lot independently.
On 3/15/2021, visited Doctor due to swollen leg and rash.  Initially thought it was due to a injury. However, upon further exam, determined that could be due to possible adverse effect to Covid-19 vaccine.   At this point, rash was isolated to lower leg calves.  Rash was raised, deep red, and draining.  Prescribed Doxycycline Monohydrate 100 mg Oral Tab and Betamethasone Valerate 0.1 .  Symptoms did not improve;  On 3/21/2021, visitied Urgent Care, due to worsening symptoms.  Rash was spreading, and still draining.  Told to stop Doxycycline. On 9/29/2021, was prescribed Prednisone On 9/8/2021.  However, upon finishing round of Prednisone, symptoms came back.   On 9/8/2021, visited another doctor with continuing symptoms. Last Derm Diagnosis was severe asteatotic exzema with statis dermatitis.  Culture showed group B staph infection. At this point was referred to Dermatology .  In the meantime, continue with steroid cream, added HCTZ.   On 10/26/2021, was seen by a doctor at Dermatology.  The rash has now spread throughout the body with continued drainage.  Papules, plaques, and patches were found .  Associated diganoses was Pruritus and hypersensitivity reaction to the vaccine.  Was prescribed loratadine,  10 mg., hydroxyzine 25 mg, . Biopsy taken of skin was inconclusive.  On 11/23/2021 was seen again by Dr. at dermatology.  No improvement on symptoms.  Two biopsies were now taken. { Currently awaiting results}.  Was prescribed Bactrim 800 Mg , Hydroxyzine 50 mg., Mupirocin.  To date, symptoms are still present, and no improvement.  Symptoms had started to  subside in a small matter approximately Aug/Sep, (2nd dose of Pfizer vaccine was received 2/19/2021,  however upon receiving  Booster vaccine in October, symptoms increasingly returned with no relief, and no matter what treatment has been provided, no subsiding of symptoms..  Itching is intense, and now, new symptom is leg numbness.  Increasingly alarmed that infection is not under control and could lead to serious further complications. Today, SEVERE drainage is being experienced on hand , and cannot be seen by my Dr until tomorro 12/7/2021.
Complained of vomiting on 11/20/02 several times for 12 hours. No temperature with diarrhea. Complained of pain in arm (left). Went to doctor on 11/25/02. Heaviness in arm and shoulder from time of shot to present. No redness or feeling hot; states doctor thought problems with shot but wants to have 3rd shot. Before 1st shot, 10/15/02, was diagnosed with irregular heart rate with fluid retention. Denies numbness or pain.
Patient reports to the pharmacy today, January 24, 2019, to receive her 2nd dose of SHINGRIX. Once weekly since her last vaccination she states she receives sharp pain at the injection site on her left arm. This occurs roughly once a week and lasts about 3 seconds. No complaints about negatively effecting quality of life. She attributes this vaccine to this reaction because she felt this same sensation when she was diagnosed with shingles.
pt recv vax 12AUG97 & 5 days later pt reported tenderness @ the inj site;over the next few days area began to swell & show redness;bruising  also devel & a hard knot;tx w/DPH, dermatopp topical, alternating heat/ice;
About 1/2 hour after vax, as I was driving home, shooting pains in my mastoid bones, and under my ears.  Later same day, pain in left arm but not at the injection site.  It was on the inside of  upper arm, mid way up and up to arm pit level (Coracobrachialis muscle).  For two days it hurt to the touch. Very hard to sleep.  Then evening of day 2 the pain/tightness went up into left side of my neck.  Mastoid bones continued to hurt off and on with shooting pains less often than at first.  Tightness spread all along sub-occipital ridge.  This has continued to this day. Very tight in neck, headaches, and the mild tinnitus I have had is now much louder.  The pain in my arm lasted for 2 days.  The other symptoms continue. Sleep continues to be to difficult due uncomfortable, painful, tight neck and loud ringing in ears
11/1/2022   I woke up with very bad diarrhea. This lasted 2 to 4 days. I saw my doctor and they took a stool sample. The presumptive diagnosis was a virus. I went back because it continued. They did bloodwork and it was confirmed that it was an infection. I also had a CT of my belly and intestine which was negative. I was put on two antibiotics, unknown. I took these for 10 days.  I was okay for about 10 days to 2 weeks, then I got diarrhea again.  I gave a stool sample, and I was diagnosed with C Diff, and I was put on a different antibiotic, Vancomycin.  I took for 10 days. I was okay for five or six days and it started all over again. I was prescribed Vancomycin again for 10 days. Then it cleared up and has not come back.  The diarrhea cleared up while I was on the antibiotic, through 12/26/2022.
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced cardiac palpitations after receiving the vaccine. The symptoms started on the day of administration and occurred several times per day for the next 2 weeks. The frequency of the palpitations has decreased and now occurs rarely. Medical attention was sought. No further information is available.
Patient called pharmacy complaining of severe arm stiffness and shoulder pain that started day after vaccine given and has continued for 2 months.
muscle is tearing away from my arm. I feel like I injured it pretty badly; muscle is tearing away from my arm. I feel like I injured it pretty badly. Burning, sharp, achy pain; Started like a pulled muscle feeling; My arm feels really heavy and painful; My arm feels really heavy and painful; I found where the pain is coming from and its right where the injection site was; muscle is tearing away from my arm; aches and pains on left side of body; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er 8734, expiration date: Jul2021) at the age of 34-years-old, via an unspecified route of administration in left arm on 14Apr2021 at 13:00 at 1st dose, single for COVID-19 immunisation. Medical history included being immunocompromised and rheumatoid arthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cholestyramine. She has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin. The patient received the vaccine at a pharmacy and on the day of the shot (14Apr2021), she experienced aches and pains on left side of body and she was extremely tired for 2 days. On 29Apr2021 at 19:00, 2 weeks and 1 day after first shot, the patient felt like her muscle was tearing away from her arm and felt like she injured it pretty badly. There was a burning, sharp, achy pain which was much worse than that achy feeling after the shot. The onset was very sudden. It started like a pulled muscle feeling. Now, she could not find a position that did not hurt constantly. There were tons of pain when she moves it and the pain seemed to worsen when she leaves it. Her arm felt really heavy and painful down at her side. She thought it was the front of her arm/shoulder, then maybe the back; but she found where the pain was coming from and its right where the injection site was. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "extremely tired" was recovered on 16Apr2021 and not recovered for all other events.
eczema; Rash of skin on stomach, back, and legs down to his knees; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient had 2 vaccines and 2 boosters. Following these injections he developed eczema from it. The dermatologists did not know what to do and how to treat this. He did not know what to do. Rash of skin on stomach, back, and legs down to his knees. He had tried multiple medications, or creams. He was taking Benadryl. Talked to 2 dermatologists. He could not go outside without a shirt.   This case was linked to MOD-2021-280030 (Patient Link).   Reporter did not allow further contact
PT HAD PAIN AT THE VACCINATION SITE, BUT A DAY LATER, SHE DEVELOPED SWOLLEN ARMPIT (FEELS LIKE A BALL IN HER ARMPIT), VACCINE AREA IS GETTING BETTER BUT STILL HURTS TO TOUCH. SHE CALLED HER MD AND WAITING FOR MD RESPONSE.
Rapid heartbeat; Nausea; Fever; Extreme pain in arm; Painful swelling under arm/breast and in neck; Burning feeling in arm; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient had no known allergies to medications, food, or other products. Concomitant medications included valuation (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and furosemide (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced rapid heartbeat, nausea, fever, extreme pain/burning feeling in arm and painful swelling under arm/breast and in neck. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rapid heartbeat, nausea, fever, extreme pain/burning feeling in arm and painful swelling under arm/breast and in neck was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
soreness at the injection site; chills; fever; weakness of the arms and legs; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2022, the patient received the 1st dose of Shingrix. In June 2022, less than a month after receiving Shingrix, the patient experienced injection site pain, chills, fever and weakness of limbs. On an unknown date, the outcome of the injection site pain, chills and fever were recovered/resolved and the outcome of the weakness of limbs was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, chills, fever and weakness of limbs to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporters Comments: The case was self-reported by the patient. The patient received first dose of Shingrix vaccine and experienced soreness at the injection site, chills and fever. The patient reported that he later began to experience weakness of the arms and legs. The reporter consented to follow up.
Information has been received from a physician concerning an 8 year old female, weight 39lb, height 48.5 inches, who on 05-DEC-2000 was vaccinated with the first dose of VARIVAX vaccine (Merck) and on 23-AUG-2007 at 16:00 was vaccinated with the second dose (also reported as the first dose) of VARIVAX vaccine (Merck) (lot#: 658422/1030U) in the left arm and the first dose of HAVRIX vaccine in the right arm.  The patient was seen in the physician's office on 29-APR-2008. She had chickenpox lesions for 4 days before the appointment. The patient was diagnosed with post vaccine varicella. On approximately 02-May-2008 the patient recovered. The patient was exposed to her grandfather who had a shingles outbreak recently. Her 1 brother and 1 sister also developed chickenpox after vaccination. (WAES#: 0804USA06382 and 0805USA05060). Additional information is not expected.
Information has been received from a licensed practical nurse concerning a 16 year old female who on 02-NOV-2007 was vaccinated with her first dose of Gardasil (Lot #658554/0928U) via injection and on 28-DEC-2007 was vaccinated with her second dose of Gardasil (Lot #658554/0928U). There was no concomitant medication. The nurse said that the patient was not pregnant during the two visits but the medical assistant said that the patient jerked and "went out immediately" after each dose and she seemed to be having a seizure. The patient recovered both times while she was in the office. They will not be administering dose 3. The patient did not receive any other vaccinations during her visits. She has no pertinent medical history and no lab/diagnostic studies were performed. No other details were available. A seizure was considered to be an other important medical event. Additional information has been requested.
Shivers, chills, headache, myalgias started at the same time. Shivers and chills lasted about 6 hours, myalgia after 24 hours and headache after 48 hours. Treated symptomatically with ibuprofen 400mg every 4-6 hours and acetaminophen 1000mg every 6 hours
The patient experienced low blood pressure (hypotension), diarrhea, dizziness and tremors.
Irregular menstral cycle. delayed start, occurring more frequently and heavier cycle. This has been ongoing since the first vaccination.
Child became fidgity in store about 1 1/2 hours after received nasal mist, but rash was not noted until approx. 4 hours later.  Welps all over her back and was itchy and very red.  More pronounced over rib cage.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that vial was kept in refrigerator on 06-Dec-2021.
First dose 2/4/2021 2/11/2021, swollen fingers on right hand 2/22 Extreme aching in right shoulder 2/23 extreme aching in left shoulder and right elbow.   3/1  Saw orthopedic surgeon as I thought I had a tear due to extreme pain (shoulder and elbow x rays done) 3/12  Saw primary care physician due to pain moving and settling in hands and feet.  Swollen feet, swollen hands 3/12 bloodwork and hand x rays 3/26 Primary care visit again and referral to rheumatologist. 4/10 extremely large bruise on leg 4/10 unable to turn head left or right Still no appointment for a rheumatoligist. This has been reported to V-safe vaccine check in and nobody has ever contacted me
COVID Arm.  Itching at injection site beginning the morning after the shot was given. By 2nd day, 4" red circle of swelling around injection site, soreness only at injection site but with continued itching. Persisted through 3rd day with redness diminishing but continued swelling which is when I am reporting.
First episode of extreme shortness of breath lasted about five minutes. After second episode of same time frame, made appointment to see doctor.
This spontaneous report as received from a male consumer of unknown age reporting of himself. Concomitant medications, medical history, drug reactions and allergies were not reported. On an unknown date, reported as (couple of years ago), the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). On an unknown date, reported as (couple of months ago), the patient developed shingles. The patient received an unspecified treatment. It was unknown if the patient sought medical attention. The outcome of developed shingles was unknown. Additional information is not expected, because the reporter details were not provided.