chrisvoncsefalvay/vaers-outcomes huggingface dataset:
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided  date of refrigeration was 19 aug 2021
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction. Treatment information was not provided by the reporter.
I felt extremely achy all over especially in my arms hands neck and back/left arm aches all the way down; I had a headache; felt lightheaded at times/slight dizziness; experienced chills on and off; But I was very tired and it lasted for around 20 hours.; not feeling normal; This is a spontaneous report from a contactable consumer (patient herself). An elderly female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL9262), via an unspecified route of administration on the left arm, first dose on 28Jan2021 09:15 at single dose for COVID-19 vaccination.  Medical history included pre - diabetic and have hypertension, known allergies Yeast and some perfumes Sulfa drugs. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication included metformin and losartan. On 28Jan2021, at 08:00 PM, patient felt extremely achy all over especially in her arms hands neck and back. She had a headache and felt lightheaded at times and experienced chills on and off. So she took ibuprofen for extremely achy all over especially in her arms hands neck and back. She had a headache and felt lightheaded at times and experienced chills on and off. But patient also stated that she was very tired and it lasted for around 20 hours. It has been 4 days since the shot and she was not feeling normal in that she have some lightheaded or slight dizziness and her left arm aches all the way down. Patient was not treated for the other events. Patient was not tested post vaccination. The outcome of the events was recovering.
Patient stated that about 1 hour after receiving vaccine, he experienced lightheadedness and dizziness. His BP went down to 77/53 which lasted for about 6 hours.
Subject first noticed her fingertips itching and burning in the winter of 2004. She had previously experienced this sensation as a child. She developed skin splints and stress fracture in Sept 2005 for which she was taking Naprosyn. In December 2005 subject noted a more severe skin reaction - itching and burning with hives all over (including in her throat). She began seeing an allergist and was treated with Claritin. She was diagnosed with Cold-Induced Urticaria for which she takes cyproheptadine and carries and epipen. Prior vaccination history includes Anthrax dose #1 FAV071, #2 FAV075, #3 FAV071, #4 FAV080, Influenza NOV-2003 and Smallpox MAR-2003.
Initially soreness in arm of vaccination site (left upper arm). Then breakout of hives and intense itchiness which began in a small location and gradually spread to multiple locations throughout my body from the neck down.
The patient called into the clinic's nurse line on 8/9/23 reporting a persistent sore left arm and possible small "knot" at site where Gardasil was injection on 7/20/23. She reports she had no soreness until about 2 days after she received the Gardasil injection and it has been sore since. The soreness never worsened, it has just been persistent. Denied rash, nausea, vomiting, fever, chills, warmth/redness at site, systemic signs of an allergic reaction (hives, pruritis, anaphylactic-type reaction), or other symptoms. She declined a same-day appointment for evaluation due to work, but accepted an appointment today, 8/10/23.  Today CRNP evaluated patient in the office. Per evaluation notes, skin is clear. A palpable vaccine lump or nodule is noted. Some concern for inflammation or bursitis but difficult to assess. Should see PCP, recommended ice and Motrin, and return in 6 weeks to reassess.  The patient is scheduled for an appointment on 9/21/23 per her preference for reevaluation of site prior to receiving Gardasil dose #2.
Lump under armpit with sharp pains radiating from lump towards heart. That area of skin feels tight and dry.
Narrative:  COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 03/03, Pfizer, dose #2 09/22 cc: dx: Acute hypoxic respiratory failure, COVID Pneumonia in a vaccinated patient, ACUTE DECOMPENSATED SYSTOLIC CHF, improved. LOS: 5 days 09/22 pt cc: cough, fatigue, dyspnea, fever, exposure: unknown 09/22 BinaxNOW COVID-19 Ag: NOT DETECTED 09/22 PT/INR 12.1/1.08 09/22 BNP: 963.3 09/22 FIBRINOGEN: 422 09/22 DDIMER: 1.60 09/22 LACTTIC ACID: 1.42 09/22 FERRITIN: 94.5 09/22 COVID swab, result: detected 09/22 SARS-COV-2 IGG Eval: 6.25 09/22 SARS-COV-2 TOTAL AB, SPIKE result: >2500.0 09/22 CTA PE impression: teral pneumonia. Please correlate with Covid status. 09/23 FIBRINOGEN: 431 09/23 DDIMER: 1.79 09/23 ESR: 35 09/23 TROPONIN I: <0.016 09/24 CXR impression Bila 1. No evidence of pulmonary embolism. 2. Bilateral peribronchial consolidation. Groundglass opacities in the periphery, more than expected for simply interstitial lung disease. This is concerning for pneumonia including COVID-19. Correlate clinically. 3. Findings compatible with UIP pattern interstitial lung disease, worsened since March 2020. teral mixed interstitial and airspace opacities with a lower lung predominance, similar to prior. Otherwise no pneumothorax or large pleural effusion. Stable cardiomediastinal silhouette. Osseous structures grossly stable with partially imaged cervical fusion hardware and vertebral cement. 09/24 FIBRINOGEN: 308 09/24 DDIMER: 1.05 09/24 ESR: 51 09/24 IONIZED: 1.05 09/25 FIBRINOGEN: 292 09/25 DDIMER: 1.00 09/25 ESR: 38 09/26 FIBRINOGEN: 308 09/26 DDIMER: 1.04 09/26 ESR: 18 09/27 COVID swab, result: NOT detected 09/27 FIBRINOGEN: 284 09/27 DDIMER: 0.84 09/27 ESR: 32
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) that was out of temperature and was not supported the in house stability. No concomitant medications were reported. No product quality issue was reported. No adverse events were reported. This case is related to case numbers 1404USA010833 and 1401USA010632 via same reporter link. Additional information has been requested.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JAN-2018, the patient was vaccinated with an expired dose of ZOSTAVAX injection (dose and route were unknown) (lot # M038351, expiration date 06-DEC-2017) for prophylaxis, which was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # L046300, expiration date 17-JUN-2018). The patient had denied any adverse effects.
Patient received Moderna COVID vaccine on 3/1/21 (lot # 001A21A), 3/29/21 (lot # 008B21A), and 11/11/21 (lot # 032F21A).  On 1/9/22, patient tested positive for COVID and admitted to our inpatient facilit with acute hypoxic/hypercapnic respiratory failure (unclear how much of this is COVID vs possible new CHF vs chronic OSA vs OHS) and worsening pain for chronic cutaneous venous stasis. As of today (1/11/22), patient is still admitted in our med/surg unit.
Pt received 1st dose of moderna vaccine and immediately reported nausea. Patient reported feeling dizziness after previous vaccinations so pharmacist was planning for observation time of 30 minutes regardless. After current vaccination, pt immediately reported nausea and then shortly after dizziness, pt was sitting down for observation time of 30 minutes and reported feeling ok before going home with her partner.
A dose of vaccine given on 11/10/2021 when it expired on 11/9/2021. Moderna contacted and dose deemed to be effective.
Chronic headaches that lasted 24 hours each day.  Became progressively worse.  Took. OTC migraine meds that eventually stopped working.  Saw Dr for first time in August of 2021 for the headaches.  Neurologist was referred.  MRI scheduled but extreme migraine put me in the local ER on 9/24/28, and Ctscan showed a tumor in the cerebellum.  Hemangioma blastoma was determined and craniotomy to remove it was performed.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 2 years old patient who experienced received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; PNEUMOCOCCAL CONJUGATE VACCINE; and HEPATITIS A VACCINE. On 08-Mar-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA via unknown route in the left thigh. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was reported that no adverse effects have been reported. 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 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.
This spontaneous report as received from a physician assistant via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route, application site, frequency lot # were not reported). On the same day of vaccination, the patient felt "sick" (malaise) and the following day, the patient experienced necrosis of the injection site. The necrosis was described as a "deep necrosis" which was removed on an unspecified date. The patient has a "deep wound" and experienced "a lot of pain". As treatment the patient underwent a debridement weekly. The reporter also mentioned the patient could not use arm for long period of time (movement disorder). The outcome of injection site necrosis, malaise, movement disorder and wound was unknown. Upon internal review necrosis of the injection site was considered medically significant. The event pt could not use her arm for long period of time was considered disabling. Additional information has been requested.
The patient was found unconscious - ambulance was called and pt was hospitalized. Her BP (according to the patient) was 80/50
Patient is a 75 y.o. female patient of MD with history of bullous pemphigoid, diabetes, GERD, hyperlipidemia, hypertension, and rheumatoid arthritis presented to Doctors Hospital with nausea and vomiting.   Gastroenteritis - resolved  Generalized weakness Patient presented to the ER with 3-day history of nausea, vomiting, and diarrhea In the setting of COVID-19 + diagnosis Afebrile, no leukocytosis, lactic acid 1.8, lipase 15, ALT 33, AST 86, ALP 205 Patient received bolus IV fluids in ER Reports symptoms have improved, no longer vomiting, but has minimal appetitie Continue supportive care, consult PT/OT   Acute respiratory failure with hypoxiaCovid-19 Virus Infection COVID pneumonia Date of onset of symptoms: 1-2 weeks ago Symptoms present on admission: Nausea, vomiting, diarrhea, fatigue, decreased p.o. intake Date of covid positive test: 11/18/2022 Vaccination status: vaccinated Imaging: Chest x-ray showed pulmonary edema, most likely COVID pneumonia, BNP 60 Oxygen requirements on admission: Saturating 90-91% on room air, desats w minimal activity down to 85% Decadron started 11/21/2022, out of window for remdesivir   Diabetes mellitus, type II, with long-term insulin Hemoglobin A1c 9.9% Patient reports she takes 15 units Lantus twice a day Will continue along with SSI and glucose checks Patient follows with Dr. of Endocrinology   Essential hypertension Restart home dose of lisinopril   Bullous pemphigoid Patient on Rituxan infusions Follow-up outpatient
I tested positive for COVID-19 on 01/25/2023. I had headache and sore throat. My sore throat gelt like it was in a different place. I also had body aches. My symptoms lasted for three days.  I also went to urgent care on 02/01/2023 due to a sinus infection, this started on 01/27/2023.  I still get tired at times but I can say I have recovered from my symptoms.
shingles; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient previously took dose 1 of bnt162b2 for COVID-19 immunisation on an unspecified date. On an unspecified date, the patient experienced shingles (hospitalization).  The patient was hospitalized for shingles for 5 days.  The clinical course was reported as follows: The consumer wanted to report a case of shingles for their 90-year-old mother in law approximately 30 days after receiving her second dose of the COVID vaccine. According to the consumer, the patient had a terrible case. The patient ended up in the hospital for five days and was in her second week of rehab. The consumer felt that shingles was probably underreported, and the consumer personally knew three people who had it following their vaccines. The clinical outcome of the event, shingles, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Patient had 5 minute tonic/clonic seizure (with fever) with prolonged post-ictal period. Was admitted for 2 days for observation and pending negative cultures. Patient recovered quickly without issue. Felt to be febrile seizure. (Admitted to out of state hospital.)
pt w/very pruritic/indurated erythematous rash w/temp to 103 24hr p/vax;on day of eval 7MAY no systemic sx;rash remains;of note working in vegetation several days before rash appeared / contact dermatitis vs drug eruption;
Bone Aches, extreme fatigue, chills, nausea starting about 12:30 pm on June 3, 2021 and continued throughout night.  Fatigue on June 4, 2021.   Second dose of COVID shot administered May 4,2021.
Had 2nd GARDASIL vaccine at 1pm, numbing and tingling in upper back (side of shot), elbow numb and wrist hurting. She couldn't put on her jacket. Pain in arm and back ended at 3pm. At 6pm started migraine symptoms, by 9 pm symptoms were "worse than a migraine" requiring a MD call and suggestion to go to ER for evaluation. 800mg of MOTRIN, didn't help.
pt was given mmr, varicella and flu vaccine on 11/13/19. pt started with rash on 11/26/19. also had minimal cough and rhinorrhea that day as well.  seen in pediatrician office today. pcp suspicious of mmr reaction or "bad batch" due to another pt given mmr with same lot # and had similar reaction.
I tested positive on 05/03/202 for breakthrough COVID. It was a mild sore throat and fatigue. A few days later I started having congestion, cough and body aches. On My 06, 2022 is when I started feeling better. I didn't have to see a doctor at all. I took two home test and they were negative. I just felt like I had COVID and I was around someone who tested positive for COVID. I did a PCR on 5/3/2022 and it was positive. This is my first pregnancy and my due date is July 23, 2022.
Developed mild chest tightness with wheeze 6 to 8 hours after meningococcal vaccine on 7/13/2004. Albuterol inhaler was started the next day as symptoms increased. She slept well through the night. She was seen by me, her PCP, the next day, two days after the vacine. Exam & spirometry were both normal. She had a prior history of asthma at age 9 years of mild degree, followed by occasional exercise-induced asthma, but none in over one year from this incident.  On 7/21/2004, six days after the first office exam and eight days after the vaccine, she returned for evaluation of a rash. She had small urticarial lesions around her waist. No wheezing on auscultation. Last inhaler use was five hours before the exam. Intermittent welts had been present for two days. Rx'd with Benadryl oral. QVAR inhaler started.
initially papular lesion devel @ inj site;pt then became febrile w/other areas of red papular rash developing on face & scalp & trunk;# of lesions 5-10;@ time of presentation, fever resolved w/o new lesions;
Lips have felt chronically dry/chapped since receiving vaccine, but in reality they are not chapped.  For the past 3+ weeks foods  with salt now taste insanely salty and the tip of tongue feels as though it was burned (it was not burned).
Headache, Myalgia, Fever, NauseaVomiting, Localized pain, swelling; chills, fatigue Narrative:
Patient experience light headedness and drowsiness. Had patient sit on floor against wall, gave patient ice pack to apply to back of neck. Symptoms resolved approximately 10 minutes after onset.
I woke up Friday night around 11:00 pm with extreme pain left upper arm and body aches. Went to a stand-alone ER. The doctor told us it was just severe inflammation and gave me an anti-inflammatory injection, hydrocodone, and an Rx for TYLENOL 3. Over the next 36 hours or so I took the TYLENOL 3 around the clock and it didn't seem to do much other than put me to sleep. I got worse over the course of time and by Sunday, 11/26/2017, around 2:45 pm, I went to a hospital ER with extreme pain to my left arm, swelling and redness covering the entirety of the upper left arm, high heart rate and blood pressure, extreme headache anytime I moved, body aches, severely dehydrated, and a fever of 102.7. A chest x-ray and blood test was ran. My WBC was at 29 and I was diagnosed with cellulitis of the left arm. I was admitted to the hospital, put on morphine, ibuprofen, and an IV antibiotic and fitted with a heart monitor. I was hesitantly released Tuesday evening, 11/28/2017 with an Rx of BACTRIM and Ibuprofen, told to watch my temperature and if I were to start running one, to contact my doctor immediately or come back to the ER. I still have the reddish/purple stain looking mark on my arm from the infection.
Sore arm; Warm at injection site; Stiff; Sore arm; Swollen; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm at injection site), MUSCULOSKELETAL STIFFNESS (Stiff), the first episode of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE SWELLING (Swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Lyme disease, Blood pressure high and Diabetes.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced VACCINATION SITE WARMTH (Warm at injection site), MUSCULOSKELETAL STIFFNESS (Stiff), the first episode of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red at the injection site). On an unknown date, the patient experienced the second episode of PAIN IN EXTREMITY (Sore arm). At the time of the report, last episode of PAIN IN EXTREMITY (Sore arm) had resolved and VACCINATION SITE WARMTH (Warm at injection site), MUSCULOSKELETAL STIFFNESS (Stiff), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.