chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness that extended from the leg injection site to the knee; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 275KY, expiry date unknown) or(batch number P7HK7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Tetra 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. The patient received FluLaval tetra 2020-2021 season with batch number either P7HK7 or 275KY. It was reported that the Immunization Consultant from the Immunization Program provided a high-level overview. It was reported that one clinic site got call and patient reported that after he vaccination with FluLaval experienced redness that extended from the leg injection site to the knee. It was stated It is possible that these were administration technique errors and not related to vaccine product quality. They are currently evaluating the administration technique and retraining. The reporter did not consent to follow up. This case is one of the 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189449:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter
A reddish circular rash around the injection site that is warm to the touch. It is also sore to a heavy press. According to research online,  it is nothing to worry about and has been seen in a small number of vaccine recipients, particularly Moderna vaccine recipients.
Shaking in left arm 5-6 hours after vaccination, which later spread to abdomen and head. Felt like head was vibrating or shaking on the inside, accompanied by nervous energy and feeling that something was not right. Interfered with ability to sleep. Seemed better in the morning but not completely resolved.  Developed lower back/flank pain 5 days after vaccine.
I had a fever, fatigue, headache, body ache, malaise, and lots of drainage of my nose. I tested positive for COVID-19. I called my doctor and asked my her for Paxlovid. I started to feel better.  I still have mild fatigue.
Extreme fatigue, soreness in muscles (arms); severe congestion in chest, bronchi; nose & head.
atopic dermatitis at the site the size that it expanded; becomes more reddened after shower and exercise; macular type rash; This case was reported by a nurse and described the occurrence of atopic dermatitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis and alopecia totalis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced atopic dermatitis, macular rash and red rash. The patient was treated with triamcinolone and emollients and protectives (Moisturizing Lotion (Nos)). On an unknown date, the outcome of the atopic dermatitis, macular rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the atopic dermatitis, macular rash and red rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced atopic dermatitis at the site and macular type rash that became more reddened after shower and exercise. The patient had been using triamcinolone and moisturizing lotion as a treatment. The patient was fearful regarding the 2nd dose of vaccine.
Developed a rash on 6/28/2021 on her neck and under her right arm, she went to Dermatologist, Dr.  at  and was prescribed an 8 day regime of Prednisone. The rash did not resolve, it spread to her arms, stomach and legs,went back to Dr.  on 7/12/2021 and was prescribed a second round of Prednisone and told to report her reaction to the Health Department as a reaction to her second COVID 19 vaccine.
Day 5 post vaccine noted development of painful lymphadenopathy and edema in right axilla that progressed to the point that right arm could not be relaxed next to side.  The edema gradually subsided by day 12 but the lymphadenopathy persisted since and this morning day 26 I noticed that I am developing fibrous cords in the axilla that are tender to touch and are starting to restrict my range of motion in the  right shoulder.  I am having to urgently see a physical therapy lymphedema specialist to address this problem.
patient given Dtap-IPV portion of that same Pentacel with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who was given Dtap-IPV portion of that same DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 12-Sep-2022, the patient received a fifth dose, once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U5256AA, 27-Apr-2023) via intramuscular route in unknown administration site for immunization patient given only Dtap-IPV portion of that same Pentacel with no reported adverse event (single component of a two-component product administered) (latency: same day).  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the event patient given dtap-ipv portion of that same pentacel with no reported adverse event.  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.
Received 2nd Covid vaccine on 04/17/2021.  On 04/18/2021, she developed neck pain, vertigo, and severe tinnitus in her right ear.  These problems improve when she's on antibiotics and/or steroids, but return once therapy is finished.  Still had not resolved at appointment on 06/08/2021.
1.Experienced soreness at injection site, mild headache for 3 days, tiredness for 3 days 2.Within a few weeks, I started encountering minor daytime LUT incontinence but not nighttime LUT 3.By June, permanent Double Vision appeared daily I made an appointment with my Ophthalmologist immediately. Numerous tests were done: complete eye exam, blood work, and brain scan.  Conclusion: I had developed Myasthenia Gravis The Ophthalmologist scheduled an urgent/immediate appointment in the next couple of days with a Neurologist with specialization in Myasthenia Gravis. The Neurologist ran a series of tests and confirmed the diagnosis of Myasthenia Gravis. It is incurable and can only be treated with medication at this time.
Less than 1 minute after receiving shots, pt. said "I'm going down" but his mother who was between him and his sister (getting a shot by nurse) thought he didn't mean it literally. He fell back toward door, touched it with his head, then fell to floor. His color was pale when he passed out. After a few minutes, he was able to walk with help to exam room to lay down.
pt recvd vax 1APR93; On 7PAR devel bulging of fontanelle, t101, r/o meningitis; 4 days later bulged again; pt is fine @ time of this report; dx as viral;
she received 2 does of the vaccine; arm was hurting after received vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (she received 2 does of the vaccine) and VACCINATION SITE PAIN (arm was hurting after received vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (she received 2 does of the vaccine) and VACCINATION SITE PAIN (arm was hurting after received vaccination). On 23-Apr-2021, VACCINATION SITE PAIN (arm was hurting after received vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.
At 1330 6/17/10 Hep B Vaccine administered to Rt deltiod IM. Employee reports that evening around 7pm began to feel like had a sore throat with "throat a little tight". Employee reports went to bed and awoke in AM on 6/18/10 with noticeable periorbital and buccal muscoa edema present. Employee reported to Employee health Clinic at 0855 on 6/18. Oral mucosa inspected with visible white lesions/patches that appears to look like musocal sloughing with out ulcerations. Slight periorbital edema still present. Employee vital signs obtained and stable; denies any difficulty breathing. Site of injection visibly inspected without redness or edema present. Employee also denies any recent illness or exposure to anyone ill in family. No uticaria, fever, headache, nausea, vomiting or abdominal pain post vaccination was reported. Employee provided with OTC Benadryl 25mg po at 905 AM on 6/18/10. At 1600 hours on 6/18/190 employee reports relief with med and denies need for further treatment.
pain in the injection arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2-3 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient  received Shingrix, 2 to 3 years ago from the date of reporting. The patient received dose of Shingrix vaccine and experienced pain in the injection arm for about 2 days. The reporter did not consent to follow-up.
Low grade fever started 12 hours after the injection lasting approximately 24 hours. After the fever broke noticed lymph nodes under arm of injection site where swollen and sore. Injection site arm also sore and tender occasionally itchy after fever broke the following two days was a little lethargic Saturday February 20th still feeling a little lethargic went for a short walk and is experiencing a little shortness of breath
DAY AFTER 1ST DOSE MODERNA COVID VACCINE HAD FEVER AND NAUSEA, NONPRODUCTIVE COUGH (MUCOUS) AND PLEURITIC CHEST PAIN. SYMPTOMS CONTINUED 5 DAYS.
*Slight shortness of breathe * Rash and itching on left side of neck * Swollen gland on left side of neck
Severe Dizziness,  nausea/vomiting, severe weakness. On April 31 I started showing early signs of Shingles, though I did not know it (because I suffer from fibromyalgia, the pain felt similar). Still not knowing I had shingles, I received my second vaccine if Moderna May 3rd at 8:30am. Later on that day my  Shingles rash appeared. I assumed it was a reaction and waited 2 days before realizing it was shingles.
Patients husband called to report incident. Patient developed Bells Palsy on 3/16/21, which was 8 days following the 1st dose of Moderna Covid-19 vaccine. She was treated by PCP and also by a specialist.  Ongoing tests and follow-up were scheduled.  She was started on several medications that the husband reporting did not know at the time.  The incident was reported to the pharmacy several days after incident.
aches; a little warm to the touch without fever; Chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), FEELING HOT (a little warm to the touch without fever), CHILLS (Chills) and NAUSEA (nausea) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included VITAFUSION MULTIVITES, CYPROHEPTADINE, GABAPENTIN (GABA [GABAPENTIN]) and L-THEANINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (aches), FEELING HOT (a little warm to the touch without fever), CHILLS (Chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL RAPID RELEASE GELS) at an unspecified dose and frequency. At the time of the report, PAIN (aches), FEELING HOT (a little warm to the touch without fever), CHILLS (Chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received the covid-19 shot and fainted once they got into their car.  EMS was called and patient was recovered and was not transported to the hospital.
made arm really sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included alcohol use.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that his/her first shot made arm really sore and the last one piece of cake .  No other side effects. The patient had noticed an increase in beer consumption.  The follow-up could not be possible as no contact details were available.
pt is deaf.   as soon as shot was administered pt was holding his heart and made a motion that he had chest pain.  pt became diaphoretic.   he wrote on a piece of paper that he had chest pain.  plain twp ems assessed him. he did have elevated blood pressure of 130/90 as well.  squad took him to the hospital.
Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 10 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00508, 0708USA00509, 0708USA00511, and 0708USA00512). Additional information has been requested.
Experienced chills around midnight of the day I got the injection. 2.5" diameter rash surrounding the site of the injection. VERY painful; I woke up every time I rolled over onto  my arm. Sleepless night. Took 2 aspirins twice during the night and throughout the day following. No relief. Injection site is hot to touch. The  chills were gone in the morning and the pain has lessened somewhat at this point but I can hardly stand to touch my upper arm. The needle was painful going in - more so than any other injection I have ever received. I am not looking forward to getting the second shot! I don't need a call from my regular doctor, just feel like my symptoms should be cataloged for others.
It started around a week after the 2nd shot, I feel dizzy, my eyes feel full/ tingling and that tingling also is in my temples that almost feels like a burning sensation. My eyes have been so tired and sensitive to light and watering.
Headache; Body aches; Diarrhea; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (brand: Pfizer), lot/batch no. and expiration date not provided, intramuscular on 20Jan2021 at a single dose for COVID-19 immunization. Medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified vaccine/s. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered at a nursing home/senior living facility. The patient was not pregnant at the time of vaccination. The patient experienced headache, body aches, diarrhea on 20Jan2021. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Starting the evening of the vaccine, about 7 hours after receiving it, began feeling lethargic. Then 2 hours later, had strong chills, which lasted for a couple of hours. In parallel also had a fever (around 101F) and headache. Fever lasted for several hours into the night. Fever subsided in the morning (around 7AM on Saturday, May 8th). Felt lethargic throughout the day, had little appetite and light headache. By Sunday was feeling better. Monday was 100% again.
Swelling, redness and pain to left upper arm started around 1:30 PM; within half hour she was starting to hyperventilate and her fingers were tingling; seen in ER at 5:30 PM, hyperventilation and tingling feelings resolved by then, only left upper arm was red hot and swollen; ER diagnosed as allergic reaction vs early cellulitis, and prescribed Keflex.
Patient reports intermittent headaches starting 2 days after vaccine and have been every day for a few hours at a time.  No neurologic symptoms.  No medications.
Headache, Myalgia, Diarrhea, NauseaVomiting, Fatigue Narrative:
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she got shingles after receiving the Shingrix vaccine. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
The vaccine was given in my left deltoid, within a couple hours my under arm / lymph node (same arm) started getting very sore. By AM,  I noticed a lump under my arm. Also one behind left ear, and my neck was stiff and sore. These symptoms have lasted quite awhile.
WAS ADMINISTERED AN UNDILUTED PFIZER COVID-19 VACCINE IN THE AMOUNT OF 0.3 ML
the vial exposed to room temperature for more than 24 hours and then administered; Expired Booster doses administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered >12 hours post puncture) and PRODUCT STORAGE ERROR (the vial exposed to room temperature for more than 24 hours and then administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial exposed to room temperature for more than 24 hours and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered >12 hours post puncture) and PRODUCT STORAGE ERROR (the vial exposed to room temperature for more than 24 hours and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The vial was initially stored in the refrigerator on 20-APR-2022. The vial was first punctured on 21-APR-2022 at 8:45AM. The vaccine on 22-APR-2022 from 10:30AM to 12:00PM. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 27 and half hours. No treatment information was provided by the reporter.
On the day of the vaccine, I only experienced arm soreness. I took Aleve at approx. 1:30 pm and 11:30 pm on 2/4. I woke up at approx 4:45 on 2/5 covered in sweat, nauseous, headache, and swollen lymph nodes.  I did not work on 2/5.  I took Tylenol on 2/5 and 2/6.  I felt better around 7pm on 2/6 .
I still have a red, a red spot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 87 years as dose 3 (booster), 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; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset Oct2021, outcome "not recovered", described as "I still have a red, a red spot".  Follow-up (11Oct2021): The initial case was missing the following minimum criteria: (No adverse effect). Upon receipt of follow-up information on 11Oct2021, this case now contains all required information to be considered valid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient tested positive for COVID 19 on 11/25/2021 and was hospitalized 11/26/2021 at Hospital and was transferred to different Hospital. Patient passed away 12/26/2021.