chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3; breakthrough infection; This is a literature report for the following literature source(s).  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent solid organ transplant recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3"; COVID-19 (medically significant), outcome "unknown", described as "breakthrough infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown result; Positive, notes: 6 months following D3, indicating antibody durability among aSOTRs.  The reporter considered "4/34 asotrs experienced breakthrough infection between 3-6 months post d3" and "breakthrough infection" related to bnt162b2.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
Got The Shot and still got them/ Suspected Vaccination Failure; still got them; Terrible Pain like Bees Stinging; This serious 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. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got The Shot and still got them/ Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still got them) and pain (Verbatim: Terrible Pain like Bees Stinging). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that, the patient got the shot and still got them, terrible pain like bees stinging. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
itchy, rash all over neck, arms, abd, runny-no temp;no coughing;
Same night of vaccination (9/30) I had fever, chills, heart pounding, muscle aches, joints aching, extreme fatigue. Next day (10/1) I had muscle aches,  joints aching, extreme fatigue, heart pounding, feeling of depression and anxiety. I also had very vivid nightmares that woke me up at night. Day after that (10/2) I woke up with several pimples (I haven't had acne since I was a teenager). This acne won't go away and is getting worse each day. I also had severe depression and anxiety and my heart was skipping a beat. I had severe fatigue again. Today 10/3 my acne has gotten worse, I feel like my menstrual cycle was affected and I have severe depression and anxiety and my heart is still skipping a beat.
Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    Concomitant medication details not reported by the reporter. Reporter reported that lost power the next day in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 2-MAR-2023-28-MAR-2023 vaccines were administered to 26 patients.  Treatment details was not reported by the reporter. This case contains information for the 23rd patient out of 26 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Throat seized up, difficulty swallowing Profuse saliva production Fever - 101.8 Weak Took Advil in evening to reduce fever
Chills; Rash itches; Rash all over her body including her face that itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash itches), RASH (Rash all over her body including her face that itches) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced RASH PRURITIC (Rash itches) and RASH (Rash all over her body including her face that itches). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, RASH PRURITIC (Rash itches), RASH (Rash all over her body including her face that itches) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided. Treatment medications were not provided.
Chills; Headache; Tiredness; Flu-like Symptoms; Aches/pain; Inappropriate Schedule of Vaccine; This case was reported by a consumer and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 8th December 2020, the patient experienced chills, headache, tiredness, influenza-like symptoms and pain. On 8th December 2020, the outcome of the chills, tiredness and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the headache, pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills, headache, tiredness, influenza-like symptoms and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and 1day after the patient had chills, pain,headache, tiredness and influenza-like symptoms. The patient first dose of Shingrix 3 weeks ago and that she received the 2nd dose day before reporting which led to shortening of vaccination schedule. The reporter asked when the 2nd dose was recommended.   The reporter refused to answer any questions related to the AE and abruptly ended the call. The reporter did not consent to follow up. Limited information was able to be collected from reporter and did not provide HCP contact information.
Itching; Pain; Swelling; Redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th April 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On 16th April 2019, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine and about 24 hours later the patient experienced pain, swelling and redness at the injection site. A day before at the time of reporting, the patient started experiencing itching at the injection site. The patient was still experiencing all of these events. The reporter did not consent to follow-up.
Prior to receiving the vaccine, my platelet levels were in the normal range. After the 1st vaccine, I noticed fatigue within 1st 24 hrs. for several weeks. With the second vaccine, I had fatigue as well but now experience bruising that I did not have before. I have not received any treatments. My hematologist did not think the numbers were so severe that the needed to be treated. I was told to return to follow up and see where my number are. I also experienced headaches for the first month or so after the first vaccine. The same thing occurred after the second dose. I do not usually get headaches, so this is not normal for me.
I started having pain in my lower back and shoulder. I had SOB. Pain in back that went up to my jaw. I went to the hospital. They did a cardiac work, came back negative for heart attack. The COVID-19 test came back negative. They did a chest CT scan to rule out PE. They show the I had COVID-19. I got swab the next for COVID-19, was negative. I still having SOB that is getting worse. They said I had a mild carditis.
Pt reports big blister forming 1 inch below the injection site about the size 3inx6in, sensitive to touch rather like a shingles outbreak. It's been almost 1 week and the blister is just going down. Tylenol and icing has helped.
Hospitalization: 1/13/2023 - 1/19/2023 (6 days) Presentation to the ED: dyspnea, chest tightness x2 days.  COVID + date: 1/12/2023 Treatment: remdesivir & dexamethasone Discharge to: deceased on 1/19/2023.  002A21A 2/24/2021 017B21A 3/29/2021 028K21A 12/28/2021
patient resulted positive to COVID-19 after vaccination; patient resulted positive to COVID-19 after vaccination; This is a spontaneous report from a contactable other hcp (patient).   This 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 27Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient resulted positive to Covid-19 after vaccination on 27Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
pt acquired full blown chickenpox w/greater than 50 lesions following varivax given over 1yr ago;chickenpox still active;
had vulvar issues and lesions; was diagnosed by biopsy as lichen planus; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm and on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: VULVAL DISORDER (non-serious), outcome "unknown", described as "had vulvar issues and lesions"; LICHEN PLANUS (non-serious), outcome "unknown", described as "was diagnosed by biopsy as lichen planus". The event "was diagnosed by biopsy as lichen planus" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: multivitamins, albuterol inhaler prn. Reported Event: I had vulvar issues and lesions which was diagnosed by biopsy as lichen planus, which had flare up after booster. After booster, I had oral lesions also for which I have seen my dentist and still getting workup for lichen planus. Due for my second booster, but worried about flare up. Have seen many case reports regarding this and want to report it. Hospitalization Prolonged: No. Known allergies: No. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit. What treatment received for the adverse event? steroids topical, tacrolimus topical, dental visit. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site blanched and  cool to touch, after the blanching, the injection site had a bluish-tinged appearance. Ice pack applied to injection site, mom was instructed to monitor site and call office back if symptoms persist or worsens.
Initially cold, chills, achy, arm pain T 99.4. By 7/16/09 progressive loss of strength both arms T increase 100.4. Saw MD 7/17/09 sent pt to ER for testing CT, X-Rays, MRI, Spinal Tap, Labwork all testing inconclusive yet numbness and weakness persisted. By 7-22-09 hands improved some difficulty writing yet seems to be resolving.
Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on 16-NOV-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL dose of Pneumovax 23 (Lot # 651406/0620F). On 17-NOV-2006 the patient developed an injection site reaction of a swollen arm which was very hard to move. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. No product quality complaint involved. Follow-up information indicated that no reaction occurred. Additional information is not expected.
Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; Painful, warm touch, red swollen rump at the site injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE SWELLING (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE PAIN (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE ERYTHEMA (Painful, warm touch, red swollen rump at the site injection) and VACCINATION SITE INDURATION (Painful, warm touch, red swollen rump at the site injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE SWELLING (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE PAIN (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE ERYTHEMA (Painful, warm touch, red swollen rump at the site injection) and VACCINATION SITE INDURATION (Painful, warm touch, red swollen rump at the site injection). At the time of the report, VACCINATION SITE WARMTH (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE SWELLING (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE PAIN (Painful, warm touch, red swollen rump at the site injection), VACCINATION SITE ERYTHEMA (Painful, warm touch, red swollen rump at the site injection) and VACCINATION SITE INDURATION (Painful, warm touch, red swollen rump at the site injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient applied ice and hydrocortisone for treatment, but the symptoms persisted.
Left mid humerus swelling 10 x 12 cm x 1/2 cm with warmth, erythema (generalized), no vesicles, pustules, red streaks. (started 1 1/2 hours after injection per pt).
PT recd Engerix-B (1ml IM deltoid) 26MAR91 & 30APR91; 12 hrs p/2nd dose (700PM) exp'd severe hives; PT went to ER & was rx'd w/Benadryl IM & Epi .25cc SC & Benadryl 75mg PO; PT stated throat feels itchy; rash subsided; no further hep vax;
Information has been received from Observant LLC, concerning an 18 year old female female with no concurrent conditions and no medical history who completed GARDASIL series on unspecified date. In December 2009 pap/colposcopy was performed indicating ASCUS. The patient was diagnosed with ASCUS prior to C1N1. At the time of the report, the patient was recovering. At this time, relationship of ASCUR prior to C1N1 to GARDASIL therapy was unknown. This was originally reported by a physician. Additional information has been requested.
Armpit pain; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 15Mar2021 at 18:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 20Feb2021 at 14:00 as a single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 16Mar2021, the patient experienced armpit pain. The patient did not receive treatment for the armpit pain. The clinical outcome of the armpit pain was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
terrible nerve pain and frozen shoulder; terrible nerve pain and frozen shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEURALGIA (terrible nerve pain and frozen shoulder) and PERIARTHRITIS (terrible nerve pain and frozen shoulder) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced NEURALGIA (terrible nerve pain and frozen shoulder) and PERIARTHRITIS (terrible nerve pain and frozen shoulder). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NEURALGIA (terrible nerve pain and frozen shoulder) and PERIARTHRITIS (terrible nerve pain and frozen shoulder) 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.   Products known to have been used by the patient, within two weeks prior to the event, included diabetic pills, blood pressure pills, blood thinner and pills for nerve pain leg.