chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; I had internal shingles; nerve pain/awful pain; 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.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (original vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient had the original vaccine and then both the doses of Shingrix, years ago from the date of reporting. After receiving Shingrix, the patient got shingles. The patient reported that, he/she had internal shingles, too.  The patient had most awful pain in his/her entire life. The patient did not even know there was such a thing.  At the time of reporting, the patient was still having nerve pain but tolerable.  The patient's doctor said, he/she might have this pain for the rest of his/her life. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
feel like I get a little warm and it went away and then it came back and then; Mouth is dry; I feel my head was warm and my left arm was hurt; I feel my head was warm and my left arm was hurt; I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath.; muscles isn't right and then I have shortness of breath; short of breath; This is a spontaneous report from a contactable consumer/patient or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 and expiry date: unknown), dose 2 via an unspecified route of administration on 21May2021 at 09:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Any other medication : Consumer stated, "Not yet. The patient was calling to see if its okay to use asthma machine because the patient was having like panic attack. The patient was taking a solution for asthma (Albuterol). The patient do take Proventil for inhaler and also have Flovent and also have machine. The patient experienced a panic attack I am not sure because my head was warm for couple of second then I was short of breath on 21May2021 (I put one second Pfizer shot today and it was 9'o clock in morning and few minutes ago I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath), muscles isn't right and then the patient had shortness of breath on an unknown date on May2021, feel like i get a little warm and it went away and then it came back and then, mouth is dry and i feel my head was warm and my left arm was hurt on an unspecified date. No treatment was received for the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath. Outcome of the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath, short of breath, muscles isn't right and then I have shortness of breath, Mouth is dry, I feel my head was warm and my left arm was hurt was unknown, feel like I get a little warm and it went away and then it came back and then was not recovered.  Follow-up (21May2021): This is a follow up-spontaneous report from a contactable consumer.  Information on Lot/Batch number was available. Additional information has been requested.
Outbreak with eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Outbreak with eczema) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Outbreak with eczema). At the time of the report, ECZEMA (Outbreak with eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
it will be more than 42 days after first vaccine dose; as painful as it was; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (as painful as it was) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it will be more than 42 days after first vaccine dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN (as painful as it was). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it will be more than 42 days after first vaccine dose). At the time of the report, PAIN (as painful as it was) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it will be more than 42 days after first vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter. for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment
The day of the shot was uneventful. The next morning when I got up, I had this overwhelming fatigue. I ate a light breakfast and went in the back room and sat in a recliner the entire day. I also drank water all day. I picked at food and all I can say was that it was like a fly in fly paper. I was on that chair all day smacked. I was completely exhausted. I fell asleep sometimes with a blanket. I was not able to concentrate on reading a book. They day went by really fast. my husband came home and I told him it felt like I lost a whole day. Overwhelming fatigue and out of it. Next day, I was fine. Recently, I'll wake up and I just have a lot of things to do. It's just such an effort to get things done because of the fatigue. It'll hit me in the morning and I just don't want to move. A lot of times I'm fighting the fatigue so that I can keep going. It's hard, and it's just like bouts. So, it's hard to get cleaning and stuff done and I don't quite have the usual stamina that I used to, so I've been getting things done in small portions.
MOTHER REPORTS THAT AFTER FIRST SERIES (CARD NOT YET AVAILABLE) BECGAN NEUROLOGICAL DETERIORATION AND IS CURRENTLY SEVERELY-PROFOUNDLY DELAYED WITH SEVERE HYPOTONIC CEREBRAL PALSY AND AN ACTIVE SEIZURE DISORDER (AS DOES THE SISTER WITH SIMILAR HISTORY), FOR WHICH A WORK-UP HAS NOT PROVIDED A SPECIFIC DIAGNOSES.  I WOULD LIKE TO KNOW IF THIS WAS PREVIOUSLY DIAGNOSED, AND ASK FOR HELP (ALONG WITH HIS NEUROLOGIST) IN ESTABLISHING OR DYSESTABLISHING A DIAGNOSIS OF VACCINE ASSOCIATED ENCEPHALOPATHY. 60 day follow up states pt has not recovered. Still has severe quadiplegia, profound delay and significant. The office and hospital records of his initial deteioration are still not available to use. Follow up on 06/09/2004: His handicap remains as before (severe CP, profound delay, seizures, fever ,a-tube) The issue of causality is confined by his sister developing comparable neurologic handicaps without a clear association to immunization, but also without an established medical etiologic diagnosis.
Ottitis Media with Effusion, Possible Acute Otitis Media, Unilateral Left Ear Beginning ~ 1 week post vaccine: Began as feeling of ear fullness progressing to ache/pain with continued feelign of fullness. Also had significant post-vaccine symptoms ~8 hours post-administration of second dose: fever, malaise, chills which mostly disappated within 12 hours. No significant issues following first administration. No History of COVID-19 symptoms.
Pt with Rash starting 24 hours after vaccine on face then to bilateral arms day 2, followed by bilateral legs day 3, scattered areas on trunk, Temp 99.8, facial lesions 1/2 cm papular erythemic with vesicular center and honey crusting started between eyes and migrated across top of head across mid-line, erythemic deep nodular lesions about 2-3 CM diameter on bilateral arms and legs. most prominent on arms, generalized swelling of bilateral wrists, no defined lesions noted.   CBC,CMP Sed Rate and CRP pending.
Severe fatigue 2 hours after the shot lasting for 36 hours. Pain throughout the upper arm that received the injection lasting for 36 hours treated with Advil.
Had Covid in December; Had Covid in December; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: 057F22A) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: PK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Previous heart attack", start date: May2005 (not ongoing), notes: Previous heart attack, May2005, 1 stent placed; "1 stent placed" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 25May2005; ATORVASTATIN, start date: 25May2005. Past drug history included:ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Had Covid in December". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Dec2022 to 09Dec2022.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 21-APR-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J013451, expiration date 24-JAN-2014 (dose and route not reported) with worst case exposure of 34F for 434 hours, Dates of excursion: 06-MAR-2014 to 21-APR-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy ), VACCINATION SITE ERYTHEMA (Red ) and RASH (Rash) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy ), VACCINATION SITE ERYTHEMA (Red ) and RASH (Rash). At the time of the report, VACCINATION SITE PRURITUS (Itchy ), VACCINATION SITE ERYTHEMA (Red ) and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported
Fever, Cough, chills, lethargic, kidney stones leading to nephrostomy tubes,
pt recvd vax 17SEP77 & 1 wk p/vax exp discomfort, fatigue & a sl fever; in approx DEC77 sufered discomfort, pain & stiffness; pain, discomfort & stiffness gradually worsened & spread to all joints;chills, rashes, fatigue, skin discolor;
Swollen lymph nodes right armpit day after injection, fatigue, dizziness was only immediately after injection but subsided, chills are off and on mild.
Patient came for flu shot 10/8/2020 and reported injection site reaction with it being red and swollen the night that she got the injection. She then went over the weekend (date not specified) to a urgent care and was diagnosed with cellulitis and treated with antibiotics and steroids.
Administered only the ASO1B adjuvant; Patient was administered only the ASO1B adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2022, the patient received the 1st dose of Shingrix. On 30th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments:  The patient was administered only the ASO1B adjuvant component of the Shingrix vaccine. The reporter consented to follow up. Additional supportive information:  The patient received only adjuvant component of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report was received from a pharmacist regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 11-AUG-2015, the patient was vaccinated with first dose of VAQTA (lot # L01405, expiry date 28-APR-2017) dose, route unknown. Then on 07-JAN-2016, the pharmacist administered the second dose of VAQTA (lot # L036878, expiry date 26-MAY-2017) to the same unspecified patient. It was reported that the second dose of VAQTA was administered one month earlier than recommended. Concomitant medications were not reported. Product quality complaint (PQC) was not filed. Additional information is not expected as reported did not wish to contact further.
The pt experienced pressure, burning sensation in left arm from shoulder to hand including numbness. Currently, still has symptoms.
This case was reported by a physician via call center representative and described the occurrence of muscle soreness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle soreness and fever. On an unknown date, the outcome of the muscle soreness and fever were unknown. It was unknown if the reporter considered the muscle soreness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that after receiving SHINGRIX, two patients developed sore muscles and fever after receipt of SHINGRIX. The healthcare professional would not give patient's initials or dates of birth, did not have vaccine lot or expiry dates. This case has been linked with case US2018154161 and US2018154163, reported by same reporter.
/11:  took Blood Pressure at pharmacy while waiting for shot 120/90. 1st shot of Moderna.  Brain fog  and then fatigue later in the day.  5/12: chest pain/pressure. Took an aspirin ~6pm.  5/13: went to urgent care. ECG normal. BP 136/86. Labs normal.  5/15: purchased BP monitor  136/90  5/16: BP 147/9X?  5/17: BP 132/76. Visit with Primary Care Dr.     Typical BP based on  Dentist Records  9/28/2020 117/69  1/20/2021 121/59  4/26/2021 92/52     As to my anxiety level. I did not have much of any anxiety on the day that I got the shot (maybe 2 on  a scale of 10)and was feeling good about starting the process of getting vaccinated. The next day I did start to become concerned when I started having chest pain.  I do tend to have anxiety before going  to the dentist 5 on a scale of 10.     Continuing to monitor blood pressure  and will reconvene with the doctor if it does not resolve in a couple weeks.
This spontaneous report as received from an approximately 60 year old male consumer reporting on himself. In 2003, the patient was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 645646/0068N exp date 26-NOV-2004) (dose and route not reported) and in 2007, after four years, the patient received the second dose of PNEUMOVAX 23 (Lot # 658075/0962U exp date 30-JAN-2009) (dose and route not reported). No adverse effect was reported. Additional information is not expected. There is no contact information.
Fever of 101 Chills  Nausea  Headaches  Muscle aches  Extreme fatigue  Swelling of forehead
had the shingles shot and can't get rid of them/ suspected vaccination failure; had shingles, can't get rid of them.; There is pain day and night; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles for 8 years).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient had shingles for 8 years and was taking medication twice a day. The reporter stated that, he/she had the Shingles shot and could not get rid of shingles. There was pain day and night. The reporter suggested to get vaccinated if the person is fifty years or older. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a social media by a physician (who is the father) refers to female patient (who is the daughter) of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL. The consumer stated that the patient went from a varsity lacrosse player to chronically ill, steroid dependent with autoimmune myofascitis (disability) after taking the GARDASIL. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
C/o hurting, mom looked and noticed redness. TYLENOL given by mom. By am, soreness gone. Redness disappeared after 3 days.
This spontaneous report as received from nurse refers to unspecified number patiens of unknown age. On an unknown date the patients were vaccinated with GARDASIL (lot# was not reported). Nurse reported the vaccine administered were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
pain in her arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A female patient of an unspecified age received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was, and concomitant medications were not reported. caller she took her second Pfizer Covid 19 Vaccine on Thursday after lunch before 2pm. She experienced pain in her arm as she did with the first dose on an unspecified date. The pain continued along with swelling and feeling a little uncomfortable that started that night. Just before 4am she experienced a fever. The rest of the day her bones were hurting especially her pelvic bone around behind her butt cheek. She had leg, arm, knee and sometimes chest pain. On that Saturday she had red blotches about 3 inches from her elbow up to her shoulder. They were cluster as well as individual spots on her left arm (injection are). Injection site has been swollen and hurting. She experienced a shocking sensation over her body. Pain from the base of her neck up the side behind her ear to the back of her head.  On Sunday she had fine boils coming up at her shoulder around to the back of her clavicle. On Sunday the bumps were itchy with a weird tingling sensation. The red blotchy all over arms have not itched. Caller continues to have pain along with the "little bumps". Caller asking if she should have bloodwork drawn. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
warm; arm felt sore again; itching; hard; the injection site is red; sore arm; hard spot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot) and INJECTION SITE INDURATION (hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Feb-2021, the patient experienced INJECTION SITE INDURATION (hard spot) and INJECTION SITE PAIN (sore arm).   On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (the injection site is red). At the time of the report, INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (arm felt sore again), INJECTION SITE PRURITUS (itching), INJECTION SITE INDURATION (hard spot), INJECTION SITE INDURATION (hard), INJECTION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (the injection site is red) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment medications reported. Patient is fully vaccinated.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: TCR attached -Events outcome updated.
CRAMPS, NAUSEA, MUSCLEACHE, HEADACHE, DIZZINESS, LOW BLOOD PRESURE, ONE HOUR. TREATMENT: BENADRYL (IV)
The night following injection, the patient experience increased anxiety, chills, possible fever, headache, backache, generalized muscle aches, and abnormally vivid dreams throughout the night. Monitoring of symptoms is continually being addressed by the patient's mother.