chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had vaccine and still got shingles/Suspected vaccination failure; Still got shingles, eight weeks now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In December 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and still got shingles, eight weeks now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Partial event onset date was captured based upon reported information.
Pain in the left arm where I was vaccinated that lasted for 48 hours; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 06Feb2021 at 10:00 AM, as a single dose for COVID-19 immunization at school or student health clinic. The patient did not receive any other vaccine in four weeks. The patient's medical history included osteoporosis and allergies: Penicillin. Concomitant medications included Lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 06Feb2021 at 04:00 PM, the patient experienced pain in the left arm where he was vaccinated that lasted for 48 hours. The patient did not receive any treatment for the adverse event. Outcome of the event was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the vaccine on  04/22/2021. On 08/29/2021 I woke up and had raised itchy spots that began on my legs. within a week I went to see my doctor. I was prescribed triamcinolone acetonide and was referred to a dermatologist. The dermatologist diagnosed me with guttate psoriasis.  By the end of the  year  the raised itchy spots spread all over my body except my face. I went to another dermatologist and was prescribed Taltz.
A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to; A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li; A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li; A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 12:00 (Lot number: Ew0173) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, administration time: 12:00 PM, Vaccine location: left arm, Lot no: Ew0153), administration date: 16Apr2021, when the patient was 31 years old, for COVID-19 Immunization.  The following information was reported: FATIGUE (non-serious) with onset 31May2021, outcome "not recovered", described as "A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to"; DIZZINESS (non-serious), DIZZINESS (non-serious), FEELING ABNORMAL (non-serious) all with onset 31May2021, outcome "not recovered" and all described as "A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li".  Additional information: Patient reported A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily life and has lasted for 2 weeks and it's no relief, I do not have health insurance so it's very hard for me to get this checked out. Patient did not receive other vaccine in four weeks and other medications in two weeks. The patient did not receive any treatment.Patient did not had COVID-19 prior or since vaccination. patient was not tested for Covid post vaccination. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Blood was coming out both nostrils and down throat and could not be stopped without intervention; went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention; Bruising also noticed on arm and leg; This is a spontaneous report from a contactable HCP (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included Allergic to penicillin (body rash). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) for Allergy pills and multi-vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 in arm left on 04Mar2021 (lot number: EN6198) for covid-19 immunization. The patient experienced blood was coming out both nostrils and down throat and could not be stopped without intervention, went to emergency room with gushing bloody nose that would stop, bruising also noticed on arm and leg on 30Mar2021 16:00. Reported as: On Tuesday 30Mar2021 went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention. Bruising also noticed on arm and leg.  Bleeding resumed after returning home from ER, used Afrin to stop (Afrin up both nostrils).  Now stabilize. The adverse event result in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected; Sender's Comments: The events "blood was coming out both nostrils and down throat" most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history was reported as may be high blood pressure and drug reactions/allergies to latex. Concomitant therapies included hydrochlorothiazide (manufacturer unknown). The pharmacist reported that on 19-MAY-2014 after the patient was vaccinated with ZOSTAVAX lot # J013449 expiration date- 24-JAN-2015, dose 0.65 ml, route subcutaneous the patient developed blistering at injection site which looked like rash. No lab/diagnostic studies were performed. The outcome of blistering at injection site which looks like rash is reported to be Not Recovered/Not Resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. Patient's pertinent medical history, drug reaction/allergies and concomitant medications was not provided. On 17-FEB-2016, the patient was inadvertently administered a dose of PNEUMOVAX 23 lot # K009107, expiration date 21-JAN-2016 (strength, dose, frequency, route was not provided). It was reported that the vaccine had expired on 26-JAN-2016. There was no adverse effects reported. No product quality complaints (PQC) involved was reported. Causality assessment was not reported. No further information provided. Additional information is not expected as the reporter cannot be contacted.
W/in 15 min post vax, papular rash on arm, subsequently spreading over body. No resp sx. No vomiting. Had not been ill. Devel diarrhea next day. No egg allergy.
Rash at injection site and above the site on her arm; across clavicle and  chest to sternum;  half way up neck.  No other side effects. Rash was gone in the morning.  Do not know when the rash appeared.  Noted it when I changed her for bed at 10 PM. (Rec'd vaccine at 1:20 PM) She had moved her arm throughout afternoon as instructed.
Left upper arm pain that is involving the entire muscle of the upper arm. Increasingly getting worse, not better. After 7 days the aching is intermittent waves of throbbing. Like a tooth ache. Had to use heat on the arm on day 6 to get comfort during the night.  Discomfort when moving of touching the arm. No local swelling or redness.
Pain at injection site initially and than overtime inability to abduct arm with continued severe pain in deltoid area.
transient lower extremity weakness; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In April 2020, 2 weeks after receiving Shingrix, the patient experienced lower extremities weakness of. On an unknown date, the outcome of the lower extremities weakness of was resolved with sequelae.   It was unknown if the reporter considered the lower extremities weakness of to be related to Shingrix.  Additional details were provided as follows: The reporter was inquiring because he experienced this symptom two weeks out from the second inject of Shingrix. The event occurred around April 2020. The weakness was transient. The reporter asked if there were any reports of transient lower extremity weakness with Shingrix. The reporter personally did not believe if there was a correlation but wanted to see if it had been reported during trials and follow up. The patient was concerned now only because of the possibility of taking the COVID vaccine. The reporter did not consent to follow up.
one had been infected with and recovered from a SARS-CoV-2 infection with symptom; one had been infected with and recovered from a SARS-CoV-2 infection with symptom; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), on 14Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "one had been infected with and recovered from a SARS-CoV-2 infection with symptom". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: The average half-maximal authentic, notes: virus-neutralizing antibody concentrations against BA.2 PRSD01, BA.1, and parental of the in the NM/r-treated patient (1668, 1170, and 5239, respectively) is 2.0, 1.7, and 2.6 times lower than the boosted and infected control. No treatment with NM/r (oral protease inhibitor nirmatrelvir combined with ritonavir (Paxlovid)). Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Patient was inadvertently administered Tdap instead of her second hepatitis B injection. According to patient she had previously been administered a Tdap. *(The previous Tdap was not administered at our facility). According to patient - there were no adverse events.
Inconsolable crying(3 hours), high fever, pain, redness, swelling at injection site and entire upper arm x 4 days at present time.
Severe arm pain and lymph node pain along chest wall on left side; intense mid-back pain, nausea, fatigue
Information has been received from a 75 year old male physician who on 20-MAY-2011 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck). Two days later, on 22-MAY-2011 the patient developed generalized myalgia and arthralgia. The physician reported he was otherwise healthy and took no medications. It was unspecified whether the patient sought medical attention. The patient was given unspecified treatment. At the time of the report, the patient was not recovered. Additional information has been requested.
"tight muscles in my neck"; "terrible diarrhea"; "was sick as a dog"; "really bad leg cramps"; "zero appetite like when I had COVID-19"; lost 2 pounds; "I feel like I have to urinate all the time"; "my bladder is very uncomfortable since getting the vaccine"; I can't eat; "a little itchy"; abdomen hurting; backside hurting; "violent chills"; "super bad headache"; "it hurt really bad"; "I am scared"; "real hot"; "started feeling really bad"; This spontaneous case was reported by an other health care professional and describes the occurrence of FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), MUSCLE TIGHTNESS ("tight muscles in my neck") and DIARRHOEA ("terrible diarrhea") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST SODIUM (SINGULAIR), Flomax, Breo Inhaler, ESTROGENS CONJUGATED (PREMARIN), Celexa, CLONAZEPAM (KLONOPIN) and Flexeril for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), CHILLS ("violent chills"), HEADACHE ("super bad headache") and MYALGIA ("it hurt really bad"). On 01-Jun-2021, the patient experienced MUSCLE TIGHTNESS ("tight muscles in my neck"), DIARRHOEA ("terrible diarrhea"), ILLNESS ("was sick as a dog"), MUSCLE SPASMS ("really bad leg cramps"), DECREASED APPETITE ("zero appetite like when I had COVID-19"), WEIGHT DECREASED (lost 2 pounds), POLLAKIURIA ("I feel like I have to urinate all the time"), BLADDER DISCOMFORT ("my bladder is very uncomfortable since getting the vaccine"), FEEDING DISORDER (I can't eat), PRURITUS ("a little itchy"), ABDOMINAL PAIN UPPER (abdomen hurting) and BACK PAIN (backside hurting). At the time of the report, FEAR ("I am scared"), FEELING HOT ("real hot"), FEELING ABNORMAL ("started feeling really bad"), MUSCLE TIGHTNESS ("tight muscles in my neck"), DIARRHOEA ("terrible diarrhea"), ILLNESS ("was sick as a dog"), MUSCLE SPASMS ("really bad leg cramps"), DECREASED APPETITE ("zero appetite like when I had COVID-19"), WEIGHT DECREASED (lost 2 pounds), POLLAKIURIA ("I feel like I have to urinate all the time"), BLADDER DISCOMFORT ("my bladder is very uncomfortable since getting the vaccine"), FEEDING DISORDER (I can't eat), PRURITUS ("a little itchy"), ABDOMINAL PAIN UPPER (abdomen hurting), BACK PAIN (backside hurting), CHILLS ("violent chills"), HEADACHE ("super bad headache") and MYALGIA ("it hurt really bad") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
First shot - Extreme fatigue occurred three days after shot (all most passed out) and lasted for a period of 5 hours.  Had fatigue the next two days, but for a shorter period.  This is the same physical effect I had when I actually contracted the COVID-19 virus in November of last year. Second shot - Second day after shot I felt as if my system was in hyperdrive; kind of a buzzing feeling. Had similar fatigue issues as before, but the hyperdrive feeling was much worse.  I couldn't function all day and laid on the couch. Third day I was fine.
Day one swelling hardness, and deep redness.  Day 2 redness, swelling all the way to elbow and unable to bend arm, pain to the point of not being able to sleep.  Day 3 fever, laying on couch and not moving.  Swelling, and some redness.  Day 4, better but still swelled, no fever.  He woulds have been better off getting the chicken pox.  He would have missed 3 days of school if it was not summer.
expansion of lips; rash around lips; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (expansion of lips) and CHEILITIS (rash around lips) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), LISINOPRIL, HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), OXYBUTYNIN, PROBIOTIC 10, TEMAZEPAM, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), MULTIVITAMIN & MINERAL, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), DONEPEZIL HCL and CEFTRIAXONE SODIUM, TAZOBACTAM SODIUM (BACTRUM T) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHEILITIS (expansion of lips) and CHEILITIS (rash around lips). On 09-Feb-2021, CHEILITIS (expansion of lips) had resolved. At the time of the report, CHEILITIS (rash around lips) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included Benadryl (diphenhydramine), Benadryl cream, hydrocortisone cream, vasoline petrolium jelly.
pt recv vax 5NOV97 & noticed welt @ inj site that evening noted gen rash legs, trunk, chest, felt hot, itchy;rash lasted 2 days then faded, itching cont;?fever-did not take temp;
the second dose would be given late; face redness; tingling lips and tingling tongue; arm felt weird, it bothered the patient and it hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face redness), PARAESTHESIA ORAL (tingling lips and tingling tongue), PAIN IN EXTREMITY (arm felt weird, it bothered the patient and it hurt) and OFF LABEL USE (the second dose would be given late) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (face redness), PARAESTHESIA ORAL (tingling lips and tingling tongue) and PAIN IN EXTREMITY (arm felt weird, it bothered the patient and it hurt). On an unknown date, the patient experienced OFF LABEL USE (the second dose would be given late). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Tingling mouth, at a dose of 1 dosage form. On 24-Feb-2021, PAIN IN EXTREMITY (arm felt weird, it bothered the patient and it hurt) had resolved. At the time of the report, ERYTHEMA (face redness) and PARAESTHESIA ORAL (tingling lips and tingling tongue) outcome was unknown and OFF LABEL USE (the second dose would be given late) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter.  It was reported that the patient consulted her health care provider and an allergist for the symptoms that she experienced and both providers recommend her to get the second dose of vaccine even though the second dose would be given late.
Patient received vaccine at approx 5:30PM on 11/28. Later that evening, patient developed a mild headache, diffuse, 4/10. Patient did not take any over the counter analgesic medicine. Patient was able to sleep throughout the night without any apparent difficulty. Upon awakening in the morning for school, patient felt dizzy and light headed. He was able to get out of bed and ambulate without falling. Patient still had a headache at that time described as the same. Patient over all "did not feel good" with "slgiht upset stomach." Patient therefore went back to bed. At approximately 9am, Dr. called the family to discuss the cost of MRI with the family. At that time they discussed the patient's symptoms and I advised them to give him some motrin for the headache and to encourage fluids. The patient's right arm, where he recieved the shot, was slightly "tense" but without any erythema or swelling or pain per the family. Of note, the patient did not have any increased work of breathing, shortness of breath, hives, rash, or facial or tongue swelling. I advised the family to keep the patient hydrated today and to come to my office in the afternoon if he was not feeling better. At approx 5pm yesterday afternoon, the patient did come to my office. At that time he still complained of mild, 4/10, diffuse headache. His last motrin was in the morning. He felt less dizzy and lightheaded. His abdominal discomfort had resovled. He had general feeling of weakness but ambulated well. No Nausea or vomiting or diarrhea. no rhinorrhea or cough. The patient was stable. I advised the family to continue pushing fluids and to continue taking tylenol or motrin for the headache. I spoke with the family at approx 10 am today. The patient still had a residual headache with "slight upset stomach" without emesis or diarrhea. He did go to school today.