chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute generalized pustular psoriasis; This is a literature report.  A male patient in his 40's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "morbid obesity" (ongoing); "hypertension" (ongoing); "psoriasis" (ongoing); "depression" (ongoing); "anxiety" (ongoing); "emergency department" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE taken for fungal infection; NYSTATIN taken for fungal infection; PREDNISONE; DOXYCYCLINE; METHYLPREDNISOLONE; LISINOPRIL taken for depression; BUPROPION. The following information was reported: PUSTULAR PSORIASIS (hospitalization, life threatening), outcome "recovering", described as "Acute generalized pustular psoriasis". The patient underwent the following laboratory tests and procedures: biopsy skin: showed psoriasi-form dermatitis with, notes: intraepidermal neutrophilic pustules, supporting the clinical diagnosis of AGPP; blood creatinine: elevated; blood culture: showed no growth; investigation: ill-appearing with chills, malaise, decreased, notes: oral intake for several days, and diffuse erythematous patches studded with fine pustules involving his trunk, arms, and legs; negative. Therapeutic measures were taken as a result of pustular psoriasis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (07Feb2022): This is a literature report. New information included: primary reporter and literature information, medical history, lab data, dose number added, product indication and dosage, treatment received updated to yes, seriousness criteria updated to life threatening, outcome changed to recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of Acute generalized pustular psoriasis. 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
she had her first dose, her arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had her first dose, her arm was very sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (she had her first dose, her arm was very sore). At the time of the report, PAIN IN EXTREMITY (she had her first dose, her arm was very sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.   Treatment details included She received the second dose on Friday and took Tylenol to prevent pain. She took 2 tablets in, the car before the vaccination, 2 tablets before bedtime, and 2 tablets in the morning.    Reporter did not allow further contact
covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 18-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) was resolving.            No concomitant product use was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was provided. Company comment-This spontaneous case concerns a 56-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 approximately 8 months 17 days after receiving third dose of mRNA-1273 vaccine. Patient had received first two doses of Moderna at an interval of 42 days which is not in accordance with the recommended vaccine interval (Inappropriate schedule of product administration). No further details on clinical course, lab test results and treatment received were reported. The outcome of the event was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report   This case was linked to MOD-2022-575214 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 approximately 8 months 17 days after receiving third dose of mRNA-1273 vaccine. Patient had received first two doses of Moderna at an interval of 42 days which is not in accordance with the recommended vaccine interval (Inappropriate schedule of product administration). No further details on clinical course, lab test results and treatment received were reported. The outcome of the event was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Inflammation both eyes 20-30 minutes after injection. No resp. distress. Sent to ER, Benadryl po.
I have now developed erectile dysfunction. Never had it before my shots. Dr is helping me but no results as of yet. I am very scared right now. Please let me know what to do.
Returned to Employee Health Clinic on 7/14- c/o of swollen neck glands lg. tender anterior cervical node on (R) and single occipital node on (L). Sore throat, (R) ear pain. Seen by MD. Strept screen "negative" considered viral. Seen by MD 7/15 with fine morbilliform rash on forearms, back & abdomen ? MD to viral exanthem vs Rx MMR. Mono "negative".
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for three patients. This is the first of three reports. An adolescent patient of an unspecified age and gender received TRUMENBA, intramuscular on an unspecified date at a single dose as protection from meningitis B. The patient's medical history and concomitant medications were not reported. The patient experienced pain, redness, and swelling at the injection site on an unspecified date. It was reported that the patient was given meningococcal group B rlp2086 one day and the very next day the patient came back with the reactions. Outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018405600 same reporter, events, suspect product; different patient;US-PFIZER INC-2018405601 same reporter, events, suspect product; different patient.
all over itching and hives; all over itching and hives; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 10Mar2021 18:30 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included Hashimoto's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took biaxin and experienced allergy.  On 12Mar2021 14:15, the patient experienced all over itching and hives. The events were considered as serious requiring doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).  The patient underwent lab tests and procedures on 18Mar2021 which included sars-cov-2 antibody test: negative. Therapeutic measures were taken as a result of all over itching and hives includes: EpiPen injection. Outcome of events was recovering.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.  Additional information received on 02Apr2021 to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
A skin rash (redness) the size of my hand appeared on my left arm. It was also sore and swollen feeling like a hard muscle. This happened about a week after the shot. I took Aleve 220 mg tablet every 12 hours and rubbed on small amount of Cortisone cream 1% on the rash. The symptoms have slowly improved over several days after the onset.
Varicella Meningitis - developed headache and fever on 9/24/21.  Vomiting and meningismus on 9/25/21 and admitted to hospital.  CSF confirmed meningitis and CSF PCR confirmed VZV.  started on acyclovir IV on 9/25/21 and continued through 10/5/21.  Has had complete recovery.
Initial report received from health care professional on 17 Dec 2009: This patient was vaccinated with FLUVIRIN 0.25 ml, intramuscular, on unknown date. The vaccine was inadvertently given to 2 years old. No adverse effect were noted after administration.
The pt experienced right upper arm erythema that was 5 x 6 inches in size.
Within a week of the vaccine, arm started to feel tender below the shoulder. Pain then radiated down the arm. Felt like a numbness and tingling, similar to nerve pain. Now the numbness has moved to all parts of the body. Patient no longer able to do day to day physical activities.
Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 27-Oct-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 27-Oct-2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 27-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 27-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Date the vial placed in refrigerator was on 18-Oct-2021. There was no temperature excursion. The patient had no adverse event. No treatment information was reported.
In first 5 min after shot felt dizzy, Remained seated for 15 min and dizziness ended. Felt slightly disoriented for one hour but able to function. About 90 min after shot, vision was blurred and began feeling the top of head burning.  Inspection of head showed no redness but burning equal to second degree burn continued for 24 hrs and treated it with cold wet cloths which eased pain.  Two hours after injection, vision improved but became hyperactive and did housework for 3 hours. Headache and fatigue began and pain in right arm shooting down to fingers. Injection shot became hot and swollen and continued.   Sore throat, muscle aches, nausea, weakness, fever, chills began 6hrs after injection and lasted  12hrs. Treated with Zofran and Tylenol. Tylenol wasn?t effective and switched to Tramadol with Tylenol was effective.
noticeable heart palpitations, never had them before in my life (that I could feel) until after vaccine
started w/pox 15MAY98-confirmed 18MAY98 by MD;no exposure known;no illness x/itching & irritable crusted by 20MAY98;
No adverse event but patient received the incorrect vaccine.  Should have received the Bivalent Booster
Two hours post vax pt developed a deep burning and radiating pain at the injection site. The pain woke her up at night. Pt also has rotator cuff pain not related to the vaccine. Follow up states as of 01/19/2000 patient recovered.
severe local rxn to anthrax immun 2 days p/vax w/20x28cm area of erythema & warmth;
Information has been received from a 67 year old female patient with no drug reactions and "shingles 10 years ago" "1 week ago" on approximately 05-MAR-2009 was vaccinated with "one dose" of ZOSTAVAX (Merck) (lot # not available). Concomitant therapy included ALENDRONATE SODIUM (MSD). "1 week ago" on approximately 05-MAR-2009 the patient experienced redness, swelling and heat at the injection site after receiving ZOSTAVAX (Merck). Those symptoms subsided after a few days but then began experiencing a tingling sensation on one side of her body that was similar to how she felt when she had shingles 10 years ago and she did not feel well in general. The patient did not have any blisters. The patient had sought medical attention from pharmacist. The patient's adverse events persisted. Additional information has been requested.
8/9/09 rash started on lower buttock and spread to belly and back and by 8/12/09 was also on both legs thigh area both legs. Today 8/14/09 rash remains the same and is not going away.
I received the incorrect vaccine, initially, at my doctor visit today. I received the  Pfizer Bivalent vaccine on Sept. 28, 2022. I presented today at the office for a Fluad vaccine. I was given another dose of the Pfizer Bivalent accidentally. I also received the Fluad flu shot today.
This is a 41 year-old who had been in his usual health until approximately May 2003. He began experiencing joint and muscle pain in May of 2003. He describes his muscle pain as being an ache that is 5/10 in intensity. He experiences his pain continuously. He states that his joint pain is primarily in his bilateral elbows and knees. The joint pain is constant with an intensity of 5/10. He was diagnosed with bilateral ulnar neuropathy with numbness in hands in March of 2004. He is also experiencing pain in his upper shoulder/neck and lower back pain. He describes this pain as constant with intermittent spasm, 7/10 in intensity. His pain interferes with his job and activities of daily living, in that he cannot lift heavy weight.  He was a heat casualty in June of 2003 while deployed. He began to experience migraine headaches and chronic fatigue. His migraine headaches are occurring on a daily basis with 3-10/10 intensity. He experiences associated nausea, dizziness, photophobia and near syncope. He states that his headaches start in frontal and progress back or from back to front with associated neck pain.   He began experiencing shortness of breath in September 2003. He attributed his symptoms to being in the desert for along period. He is now unable to walk long distances due to his shortness of breath. Additionally, he states he becomes short of breath if he is talking for long periods.  He has rashes that appear primarily on his upper body that began in September 2004. He initially had blister like bumps on his arms. In April 2004, he experienced a rash on his stomach that was diagnosed as leishmaniasis, which confirmed by biopsy. He has begun experiencing new rashes on his upper body that has not been explained. The client describes his current rash, as round circular (the size of a quarter) lesions with associated scattered small bumps on his upper posterior torso and scrotum.  He is currently in the Wellness Program. He is on Medical Hold. He has just completed signing of his medical board and is awaiting demobilization orders to return to his home of record.
Information has been received from a healthcare worker concerning a 15 year old female patient who was vaccinated IM with the first 0.5 ml of GARDASIL (Lot # 666929/0331Z) on 12-AUG-2010, and the second dose on 12-OCT-2010. On 13-OCT-2010 the patient started feeling dizzy which lasted all day. AE onset date was also reported as 12-OCT-2010. The patient 's feeling dizzy persisted. The patient did not seek medical attention. Follow-up information has been received from a physician concerning the 15 year old female student with no illness at time of vaccination felt dizzy and extremely tired for 24 hours. The patient felt like fainting for 24 hours. The patient's events recovered 24 hours later. No further information is available.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA251031 and 2018SA251067 (same reporter). This case involves a patient an unknown demographics who was vaccinated with a dose of ACT-HIB (Batch number: A111A, expiration date: 19-Sep-2020, dose, route and site of administration were not reported) on an unknown date, which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was also reported that refrigerator temp reached 56 F for 15 days from 01-Aug-2018 to 15-Aug-2018. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This initial spontaneous report was received on 15-AUG-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 19-SEP-2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot #, were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-APR-2016, he was treated by a physician at a walk-in clinic for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 17-SEP-2016, the male patient was treated again by the same physician, for ongoing and worsening symptoms of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Information has been received from a consumer concerning her 71 year old sister with no known allergies, high blood pressure and diabetes who in September or October 2007, was vaccinated with a single dose of series of zoster vaccine live (Oka/Merck). Subsequently, around 14-MAR-2008 the patient started to break out in shingles and had a lot of pain. Medical attention was sought. The patient's back hurt so she went to a chiropractor who stated she had red dots on her back.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates from 01-AUG-2017 to 14-SEP-2017, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as M035828, expiry date 28-MAY-2018 (albumin status, dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 13 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Lot number M035828 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1709USA011237.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th October 2018, 2 days after receiving SHINGRIX, the patient experienced pain, skin scaly, pimples, skin irritation, pruritus and erythema. On an unknown date, the outcome of the pain, skin scaly, pimples, skin irritation, pruritus and erythema were not recovered/not resolved. It was unknown if the reporter considered the pain, skin scaly, pimples, skin irritation, pruritus and erythema to be related to SHINGRIX. Additional details were provided as follows: At around 10:00 AM, the patient received a dose of SHINGRIX on left arm. The patient was at a football game and all of the sudden the patient had a breakout on her elbow that the patient described as a patchy section which was red, pimply looking area, irritated and scaly. This area was about 3 to 4 inches and 1 to 2.5 inches wide. The patient had concern about that, she might have shingles based on the appearance of the area but the patient was unsure. The patient was planning on see her physician on 10th October 2018.