chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dispensed dose of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna Covid-19 vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient neither diagnosed with COVID-19 nor tested positive. Patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long-standing health conditions.     On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were taken by the patient. The vial did not undergo any temperature excursion and it was unknown when the vial initially stored in the refrigerator.  It was reported that patient did not experienced any adverse events. The results of moderna stability study showed proper activity againt COVID-19   Treatment medications were not reported.
Patient stated she experienced pain in the area below her neck and above her chest which made it difficult for her to breathe.  Patient was unable to walk and supported to sit on the ground by her parent.  Symptoms improved after 5-10 minutes and patient appeared to recover after 20-25 minutes.
Area is swollen, hot red to left thigh. Treatment CLENDA 75/5 1 top po tid x 10 days.
Pt reports localized pain to left deltoid persists. Has had imaging and EMG, Neurology consult, PMNR and no resolution so far.
I had the expected flu-like symptoms for a couple of days, and then on Day 3 got nauseous and started feeling tingling on my face (below the nose and around my mouth. It felt like pins and needles. When it went on for several hours I called Hospital and they advised to contact them if it worsened of I began having symptoms of Bells Palsey or a stroke (not concerning at all!)  I took tylenol then ibuprofen and it went away. It's come back two more days (up to today) but has not worsened. Just thought I should report it.
She was challenged with pneumococcal vaccine PPV23; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 64-year-old female patient. Her concurrent condition included chronic spontaneous urticaria, hypertension, hyperlipidemia, rhinitis allergic, glucose tolerance impaired, gastroesophageal reflux disease, atrial fibrillation, chronic kidney disease and diverticulum. The patient's medical history included pyelonephritis, osteomyelitis, hepatitis viral test negative, rubella, scarlet fever, measles, measles, Surgical history was significant for tonsillectomy in childhood secondary to recurrent streptococcal pharyngitis, appendectomy with peritonitis at age 5 and tonsillectomy.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, frequency, strength, route of administration and anatomical location were not reported) for challenged.  Literature report:
This spontaneous report was received from a Medical assistant referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reaction, allergies and concomitant medication were not reported. On an unspecific date the patient was administered with improperly stored ROTATEQ (lot # M018957, expiration date 22-NOV-2017)(strength and dose were not provided) orally for prophylaxis.  It was reported that the temperature excursion was for for a total of 10 hours and was exposed to 1.36 C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist, via a company representative, refers to a female patient of unspecified age (older than 65 years). The patient's medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot numbers and expiration date were not provided). No concomitant therapies were reported. On that same date, Three hours after vaccination, the patient called the pharmacist and reported a rash on her knee which the patient thought was spreading. The outcome of rash was unknown at the time of the report. The reporter did not provide a causality assessment for the event. Additional information has been requested.
Blood clot on left leg from knee to the groin area. Never had problems before,  not 1 person in my family ever had this , not long trips , ground or Arial.
Soreness at injection site for 48 hours Mild fever (100.2°F) for about 3 hours starting about 24 hours following the vaccination
About a week after receiving my second dose, I started to feel like I was achy and I was hurting all over. I had a lot of pain, especially in my left arm, which is the side that I had breast cancer. Under my left breast was hurting as well. I had surgery to remove lymph nodes from my breast on 02/09/2021. I went to my doctor on 03/09 and I advised that I was having frequent urination with blood in my urine. I was referred to a Urologist, who I saw on 03/12. They put me on an antibiotic and did a cystoscopy. I had the cystoscopy on 03/25. Other adverse events that I'm experiencing are vertigo or feeling dizzy spells. I am also experiencing blurred/hazy vision and numbness in my extremities. It seems that every night, my hands, arms, legs and feet will be tingling or be numb. The main place is in my feet where I will have shaking/trembling occur and shoot to my legs. My hands will also shake at times and my fingers and joints hurt. I did go through radiation after my symptoms started, but that was for my cancer. Overall, I just feel achy all the time.
Fainting within less than 5 minutes of vaccination, very low heart rate, head injury, ambulance arrival and transport to Hospital where Patient received care. Laceration on head, low heart rate and concussion required Patient to be out of work, unable to drive and required PCP immediate follow-up.
HAD A REACTION; PSORIASIS STARTED TO COME BACK AND THEN FLARED UP; STENT PLACED; This solicited report received from a consumer via Pharmacy concerned a 47 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. The patient received combination product golimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: LDS00MA expiry: 31-MAR-2024) 50 mg, 1 time every 1 months, therapy dates were not reported for psoriasis. Product constituent parts included Ultrasafe passive (route of administration, lot, serial number, model number, UDI number, and expiration were not reported); and Ultrasafe passive accessory (route of administration, lot, serial number, model number, UDI number, and expiration were not reported). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after patient had his covid vaccine, he had a reaction and a couple of weeks later, his psoriasis started to come back and then flared up. It was unknown if patient was taking Simponi at the time of vaccination. It was reported that, Simponi will be discontinued and he will be switching to Cosentyx. On unspecified date in NOV-2021, the patient had stent placement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of golimumab was not changed. The outcome of the psoriasis started to come back and then flared up, had a reaction and stent placed was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and stent placed, and had a reaction was related, and between covid-19 vaccine ad26.cov2.s, and psoriasis started to come back and then flared up was not related; and between golimumab, and stent placed, psoriasis started to come back and then flared up, and had a reaction was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220341028-COVID-19 VACCINE AD26.COV2.S -Stent placed. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.
diarrhea two days after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-MAY-2022 Reporter's Comments: The case was reported from patient via interactive digital media. The patient experienced diarrhea 2 days after the dose of Shingrix. Additional Supportive Information: The follow-up would not possible as no contact details were available.
3/24/2021 11am vaccination A couple hours later, I went back to work. I started feeling pains in my neck and feeling 'off'. The pain went to my hands, achy, and numbness radiated to feet. Felt awful driving home. Four hours, my body felt like 'hit by a baseball bat'. I did take some Tylenol and Ibuprofen. I went to bed, started to get chills with heating pad, felt like I just needed to sleep. My husband kept me hydrated. It hurt in my neck.  My temp was between 103-104. Included shaking, chills, sweats, fatigue.  A few days later, pain from shoulder to my neck. Past weekend, I went to see my chiropractor as I couldn't make pain go away, unless I lifted my arms. This is the only time I have ever seen a chiropractor and saw them a total of 8 times. They wanted me to go to 12 but it was 'getting expensive'.  *pretty much gone away *COVID +, Jan 2021
A non-serious spontaneous report of "an employee who also has a history of asthma, inadvertently received H1N1 LAIV" and "patients asthma is worse after she got H1N1 LAIV" has been received from a pharmacist, concerning a 43-year-old female subsequent to H1N1, Intranasal. The patient had a history of asthma. No concomitant medications have been reported for this patient. On 06-Nov-2009, the patient received H1N1, Intranasal for unknown indication. In Nov-2009, starting next week after the vaccine administration, the patient noticed that her asthma progressively got worsened and it was resolving after antibiotics and steroids were given, at the time of report. The outcome of the event of "employee who also has a history of asthma, inadvertently received H1N1 LAIV" was considered as recovered, while that of "patients asthma is worse after she got H1N1 LAIV" was recovering at the time of reporting.
Healthy 11 year old developed sudden onset of back pain, paresthesia and weakness, transfer to hospital ICU - diagnosis acute transverse myelitis.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for myocardial infarction. Vaccination took place 2/3/09. According to physician relationship is 'none'.
5/13/2023  I was sitting down, my ears started ringing loudly. Then I got very dizzy, the room was spinning around and I leaned to my left. I thought I was going to fall out of my chair.  This lasted for about 15 minutes. I also was nauseous. I had this five more times, the last time was twice yesterday.  I went to the doctor on 5/16/23.  She felt it was an inner ear thing, but was not sure. Yesterday I went for an ultra sound , unsure of results. I was given Meclizine for vertigo.
Got the poke and ended up getting shingles/Suspected vaccination failure; Shingles; 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 poke and ended up getting shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a consumer via interactive digital media. The patient got the poke (shingles vaccine) and ended up getting shingles. 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. The follow up would not possible as no contact details were available. This case had been linked to US2023AMR067344, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR067344:Same reporter
My son started to have little no movement on the right side of his face. I took him to the ER and he was diagnosed with Bell Palsy.
severe Headache started the next evening along with sore throat, cough, sweating, chills, pounding/throbbing in the ears, trouble breathing, elevated heart rate symptoms persist through today 4/15/21
Moderna COVID-19 Vaccine EUA,: headache, weakness, nausea, achy body, rash on arm where shot given that itches, temp, night sweats, trouble regulating body temp, chills, slight change in taste. Symptoms lasted an entire week. Rash is still there two and a half weeks since shot along with a lump at injection site. Still have occasional headache like one I had following shot.
Adacel temperature excursion range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction with no reported adverse event; Adacel administered after temperature excursion with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA302671.  This case involves a 13 years old female patient it was reported diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] had temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event and Adacel administered after temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that adacel had temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event (product storage error).  On 11-Jul-2022, the patient received a  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (strength: unknown) (lot U6923AA and expiry date: 21-Jan-2023) via intramuscular route in the left deltoid for immunization was administered after temperature excursion with no reported adverse event (poor quality product administered)( latency : same day).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Patient has cerebral palsy and scoliosis.  Her nurse alerted the pharmacy that the patient was hot and anxious.  She used an ice pack on her neck and drank some coke.
Right upper arm with large red, indurated area that is tender to touch and palpitation x 2 days. Used Benadryl and cold packs
Pt feels fine- When I called to his home- per family member that speak a little english.
Came down with Zoster shingles virus - full outbreak. Outbreak location: Upper left torso, back, armpit, chest.
Herpes simplex on face; Taking acyclovir until blisters disappear; This case was reported by a consumer and described the occurrence of herpes simplex in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex (on her face and mouth ever since patient was child). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (had approximately 10 years ago). Concomitant products included rosuvastatin and lisinopril.   On 11th November 2022, the patient received Shingrix. On 20th December 2022, 39 days after receiving Shingrix, the patient experienced herpes simplex and blister. The patient was treated with acyclovir (Acyclovir Tablets). On an unknown date, the outcome of the herpes simplex and blister were not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This report was submitted by public reporting. This report was submitted via the online direct entry reporting system. The reporter was the patient.  The patient previously had a shingles vaccine approximately 10 years ago and broken out shingles.  The patient had a history of herpes simplex on her face and mouth ever since the patient was a child. The patient took the new Shingrix shot a month ago and now had herpes simplex break out on her face. The patient did not had any itching or pain and still do not.  Fortunately, patient had some acyclovir tablets 400 mg so she took one today and will continue to take them until the blisters disappeared.  The patients next dose due in January 2023.  The reporter wanted to know if this was common reaction.  The reporter consent to follow up.
Swelling, hot to touch, not painful, but spreading. Instructed to apply cold compress or ice and Benadryl every 4 hrs
palisaded neutrophilic granulomatosis dermatitis; Foreign body granuloma of skin and subcutaneous tissue; rubella virus granulomatosis disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included multiple sclerosis.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as seven years after vaccination), the patient experienced papules that grew to larger pink to violaceous plaque involving the left arm which was diagnosed initially as granulomatous dermatitis and was treated with hydroxychloroquine without benefit. After twenty years from the onset of the event, an skin biopsy was collected and histopathology results showed Palisaded and foreign body granulomatous dermatitis with concern for follicular rupture, infection, or consideration of palisaded neutrophilic granulomatous dermatitis, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 754 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 2251.2 mm3, CD3 CD4 T cells count: 895.2 mm3, CD3 CD8 T cells count: 1382.8 mm3 (elevated; reversed CD4:CD8 ratio), Activated T Cells HLA-DR CD4: 9.86%, Activated T Cells HLA-DR CD8: 40.6% (elevated), CD19 B cells count: 52.97 mm3 (low), CD56 CD16 NK cells count: 658.1 mm3, T-Cell mitogen proliferation: 103%, Rubella IgG titer: 1171 IU/ml, Rubella neutralization titer: 5120 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease ( Palisaded neutrophilic granulomatous dermatitis,  granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
A report was received from a health professional on 18Oct02, concerning a 6 month old female vaccinee who inadvertently received the Fluvirin vaccine on 17Oct02. On 17Oct02 a 6 month old vaccinee received 0.5ml of the Fluvirin vaccine. There was insufficient information to determine the reporters causality assessment.
Pt recv vax on 4/28/99; on 4/30/99 pt exp local allergic rxn of erythema, swelling, warmth
Acute congestive heart failure;  diuresis initiated.  The patient had abnormal EKG with first-degree AV block, right bundle branch block and left anterior fascicular block.  He was evaluated by cardiology with recommendation for a 30-day event monitor to see whether the patient is in need for pacemaker or not.  The patient started physical therapy and has agreed with social services recommendation to go for short-term rehab. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
I had a congestion, coughing, body aches,chills, no fever, and heat swings. These symptoms did not happen all at once. I took at home test  COVID-19 and it came back positive.
Within a day his whole upper arm swelled significantly; was red and hot, took an antihistamine, swelling went down. 10 days following shot broke out in hives around site, very itchy, swelled again.