chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site allergic reaction. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site allergic reaction were not recovered/not resolved. The reporter considered the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the case on behalf of the patient. The age at vaccination was not reported. The patient never had chickenpox but the health care professional recommended her to receive the SHINGRIX. The patient received SHINGRIX on an unknown arm. The patient had redness, swelling and a lot of itching at the injection site. On 15th March 2019, the patient reported that the itching was severe and she probably should have contacted the pharmacist sooner regarding these symptoms. The pharmacist advised her to contact her health care professional for evaluation of the itching. There was no associated PQC (product quality complaint). The local and general adverse reactions were reviewed with the pharmacist, who also had a copy of the PI (package insert) for SHINGRIX. The pharmacist would reach out to the patient again to have her contact with physician for possible allergic reaction to the vaccine.
Information has been received from a physician concerning an 11 year old female pt who on 4/24/01 was vaccinated with Hep-A virus vaccine inactivated. There was no concomitant medication. On 4/26/01, the pt presented to the office with severe muscle pain throughout her body, she could not move or walk. When the child tried to move it hurt so bad she cried. The child had a temperature of 100F and her blood pressure and pulse were normal. Additional information has been requested. Upon internal review, gait abnormality and movement disorder were determined to be "Other Medical Events".
developed itchy rash under left lip about the size of a nickel.  Treated with steroid cream with helped to alleviate the itching. Painful blisters occurred 4 days later. Lymph nodes under chin on left side became very tender all the way to my ear. This caused ear pain that required use of heating pad to alleviate some of the discomfort. On day 5, lymph nodes in neck also became tender. Decided to go the urgent care on Aug 2. He treated me with Valacyclovir 1000mg twice a day for 7 days. He thought it could be herpes labialis even though I have never had this previously.  I completed this treatment but I still have a red bumpy spot where the original rash was.
This child received vaccination on 03/30/98 at the age of 12 1/2 months. Onset of varicella disease 01/04/01 and possibly father of child also.
Infection with covid-19 was detected; Infection with covid-19 was detected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "unknown" and all described as "Infection with covid-19 was detected". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Infection with covid-19 was detected. Infection with covid-19 was detected 09Jul2022, 09Jul2022using BinaxNOW antigen self-test. Symptoms included sore throat, hoarse voice, cough, fatigue, nasal congestion, runny nose, headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 1st dose moderna vaccination and shortly after c/o feeling light headed, tingling in legs, dizzy. BP 200's/60's. ED called via radio, take to ED via WC.  Pt received care in ED.
Sneezing, stuffy, and runy nose all day 12/17. Diarrhea, followed by extreme vertigo and nausea at 10:15 AM 12/19 including 1 incidence of fainting.  Around 12PM on 12/19, a temperature of 99.7 was taken and chills were experienced from ~11:00 AM until roughly 2:00 PM on 12/19. Extreme vertigo lasted for about 15 hrs and nausea lasted until around 12:30 PM on 12/20 with milder vertigo.  Diarrhea lasted through about 12PM 12/20.
Extremely sore arm.  Loss of range of motion in the left arm.  Unable to sleep on my left side.   Over the last four months, the pain has diminished but I'm still have a limited range of motion in my left arm.
"...noted she had  back, neck & four extremity rigidity with tonic / clonic seizure movements. It appeared like a petit grand mal seizure with facial pallor, loss of consciousness, some saliva foaming formation on lips. ...The patients pallor and bradycardia (48 bpm)  was evident, the patient was breathing on her own and able to respond to direction and pain stimuli.(2 minutes from initial evaluation.) The seizure like signs and symptoms resolved quickly She was able to place her head between her knees after 30 seconds with her feet on the floor. Her mentation  improved rapidly..." Evaluated by EMS, refused transport to ED. PMD followup unknown
mom found pt w/eyes rolled back in head & rigid then muscles went limp; called 911;
Patient reports continuing pain in deltoid region at 3 weeks post vaccination 1.  No redness or swelling reported by patient and no pain in shoulder.
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given Moderna Vaccine Covid-19 on 30JUNE2021 at 4:48pm, however the beyond use date was 29JUNE2021 6pm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jun-2021 at 4:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given Moderna Vaccine Covid-19 on 30JUNE2021 at 4:48pm, however the beyond use date was 29JUNE2021 6pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given Moderna Vaccine Covid-19 on 30JUNE2021 at 4:48pm, however the beyond use date was 29JUNE2021 6pm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were mentioned. No treatment details were reported.
Caller stated that on 8/12/2020, the patient was administered improperly stored PROQUAD (reconstituted with properly stored Merck STERILE DILUENT).; This spontaneous report was received from a medical assistant referring to a 5 years old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 19-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (rHA) (PROQUAD) lot # T001187, expiration date 11-JUL-2021 for prophylaxis (reported as well check) (reconstituted with properly stored MERCK STERILE DILUENT) (lot #, expiration date, dose, frequency and route of administration were not reported) (product storage error).  The improperly stored suspect vaccine experienced multiple temperature excursion of - 9 Celsius degrees (°C) to 8°C (average -6.1°C) for 1 hour and 15 minutes. The call was made due to a digital data logger. No previous temperature excursion was reported.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with ROTATEQ (lot#, expiration date and dose not reported), orally. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter did not want to be contacted.
pt was adm on 31JUL98 w/ fever, chills, nausea, shakes, h/a, neck pain & photophobia;pt recv IVIG on 28JUL98/29JUL98 & pneumovax on 28JUL98; since then pt c/o inc pain, temp & erythema @ the site of pneumovax inj in lt upper extremities;
Lips numb, hypotension with dizziness. Placed as allergy in medical record.
Breakthrough infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Breakthrough infection) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Breakthrough infection). At the time of the report, INFECTION (Breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  By the end of September moderna two covid 19 vaccine measured as 89 percent effective in march was only 58 percent effective. Amoung the patients 65 and older who were inoculated with the moderna vaccine those who developed the so called breakthrough infection were 76 percent less likely to die of covid 19 compared to unvaccinated veterans to the same age. Older patients who got pfizer biontech vaccine subsequently experienced breakthrough infection were 70 percent less likely to die of covid 19 compared to their invaccinated peers. And older patients who got single jab of J and J vaccine suffered a breakthrough infection were 52 percent less likely to die of covid 19 compared to who did not get any shot.  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.
Patient woke up with facial swelling >10 hours after vaccination.  Family took her to the ER and she was given benadryl which resolved the swelling within three days
Red blotch, swelling and firmness at injection site after 3 hours Fever, chills and sweats after 24 hours Itchiness at injection site, Headache, nausea  and fatigue after 48 hours
Sever muscle pain,  intense shivering, fever and sweating, intense intestinal pain,  and nausea from 12am to 7am. I was ready to dial 911 but fell asleep. When I woke-up I was drenched in sweat but felt good enough that I did not dial 911. Other than being tired for the rest of the day the adverse reactions were gone.
Pregnant at time of vaccination O24.420 - Gestational diabetes mellitus in childbirth, diet controlled Z34.90 - Encounter for induction of labor
~27 April: mild stiff neck 30 April: cognitive dysfunction with executive dysfunction and problems with short term and working memory 04 May: anxiety, worsened executive dysfunction; headache, nausea, and vomiting 04-17 May: visual disturbance with sudden "jumping" of visual field, consistent with ocular myoclonus 05-06 May: headache and nausea slightly better 07 May: headache and nausea worse; cognitive dysfunction and anxiety worse; that evening: mild segmental myoclonus involving all extremities 08 May (early morning): presented for emergency care; general lab work wnl.  Admitted to psychiatry unit 09 May: started on sertraline 25 mg  10 May: MRI brain attempted, but aborted due to patient panic attack on arrival to MRI scanner 11 May: headache and nausea resolved 09-11 May: cognitive and behavioral symptoms (executive dysfunction, anxiety, respectively) getting better 11 May: headache and nausea resolved 12-17 May: visual disturbance resolving Symptoms of anxiety continue to improve, but remain mild and present as of 11 June.  Cognitive symptoms have resolved.  Headache and stiff neck have not recurred.
On the Saturday I had soreness at the injection site and tiredness. On the Sunday; Headache, pain, itch and 4 inch diameter rash at injection site. In left earI had tenderness and my left underarm had pain. Monday tiredness gone but (pain, itch and 4 inch diameter rash at injection site. In left ear had tenderness and left underarm had pain) remained. On Tuesday I consulted with a pharmacist at the pharmacy where vaccine was administered and upon inspection was advised to place cold compress on injection site to remove swelling; and take ibruprophen for pain 3 times a days. I applied cold compres and took ibruprophen once a day. Today Thursday the swelling remains but the itch and rash are almost gone. Left inner ear and underarm tenderness has gone.
pt recv vax 17NOV98 & onset of adverse event occurred on this date but pt was seen in clinic 18NOV98;ice was applied to rt deltoid induration 3" x 3" & instructions to return to clinic in 2 days were given;
Pt and husband came in to get 2nd dose of their Shingrix.  Husband received 1st dose 12/15/20 and wife which is the pt received her first dose 1/2/21.  Pt stated their doctor said they are both due for their 2nd dose.  Checked the 1st dose date of husband and mistakenly wrote that was 1st dose date for both patients.  Upon scanning vaccine consent forms later in the day into EPRN, realized that the pt's 2nd dose of Shingrix is ~1 week early.    No reported adverse events as of today.
Symptoms started within a couple of days of vaccine. I experienced what I thought was eczema related rash because my skin is sensitive and I thought I had used soap or a cleanser that was irritating my skin but it was behaving like hives. It was on my torso, legs, and it would shift around so it wasn't very consistent. At first it was on my torso, and then a few days later it was on my legs. A number of days later, I had it on the left side of my scalp and it presented more of shingles scabbing, and I've had shingles before in the past so I am familiar with it but I didn't have the pain aspect of it. It persisted for a number of weeks so I was a doctor and they thought it was an eczema reaction and they didn't tie it to the booster. Typically when I've had eczema reaction it appears in one place and antihistamines usually clears it up, but this time the antihistamine didn't help and it took 2 months to resolve. I've still been battling flare ups.
nausea, vomiting, fever 101 & flushed feeling p/vax;
Tingling and numbing sensation in the left and right feet and toes (10/28/21 to 9/2/22).
Itchiness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal.   On 01-Feb-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 02-Feb-2021, the patient experienced PRURITUS (Itchiness) and ERYTHEMA (Redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 04-Feb-2021, PRURITUS (Itchiness) and ERYTHEMA (Redness) had resolved.            The consumer followed up with her PCP and was informed by PCP that these are common side effect and her immune system is responding to the vaccine.  The consumer stated that she took Tylenol rapid release gel cap and Hydrocortisone 1% to subside her side effect.  The consumer also stated she is currently taking cholesterol and blood pressure medicine which she did specify which ones.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Immediately weak and light headed after shot.  Next morning had red itchy bumps all over both legs. Almost 3 weeks later has not gone away
Itching on injection site, itching on same side arm and neck. A couple days later noticed a sort of hive surrounding injection site.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand: Pfizer/BioNTech, Dose number: 3; Vaccine brand other: Moderna, Dose number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Apr2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech, Dose number: 3; Vaccine brand other: Moderna, Dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given for COVID 19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer reporting on behalf of his son through a Pfizer employee. A male patient of an unspecified age and ethnicity received TRUMENBA on 16May2016. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever and chills, both on 16May2016, 6-10 hours after the vaccination. Therapeutic measures were taken as a result of the events. The patient woke the reporter up in the middle of night with these symptoms and was then taken to the ER/hospital. The outcome of the events was unknown. Follow-up (17-May-2016): New from the same contactable consumer includes: events considered serious and events clinical course details. No follow-up attempts are possible. No further information is expected.
40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022.  On 28 Jan 2022 Maximum or minimum temperatures reached range was positive 34.7F to positive 41.2F, on 30 Jan 2022 temperature range was positive 34.7F to positive 41.2F which occurred approximately for 48 hours, on 31 Jan 2022 temperature range was positive 34.7F to positive 41.2F for 12 hours and on 04 Feb 2022 temperature range was positive 35.2F to positive 41.7F for 12 hours.  No adverse event was reported.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-539812, MOD-2022-540812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow-up received contain significant information Patient Information, Dosage Information, Reporter details were updated.
Post vax, the pts developed an injection site reaction that included redness, tenderness, swelling, and hot to the touch. No fever was noted.
Shoulder sore and over a period of a few weeks had progressed to frozen shoulder with muscle spasms and loss of ability to raise left arm to side and behind back.  Numbness and tingling to left thumb and index finger.  Unable to use left arm for lifting more than 5# for 10 months then was very weak.  Went thru several months of physical therapy and one shoulder manipulation procedure along with numerous anti-inflammatory drugs.  Over the course of 2 years the shoulder pain has progressed to other joints and I am now seeing a rheumatologist for this.  I am still unable to use my left arm to its full potential due to the limited range of motion which has resulted from the flu shot.
mom stated pt had an allergic rxn & was crying non stop & devel hives;pt to MD who said that the pt is allergic to pertussis-mom did not call the clinic when this incident happened or go to ER