chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bivalent Moderna COVID-19 vaccine Beyond 30 days in the refrigerator; No adverse event; Dose administered after 30-day Use By DateProduct; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By DateProduct), PRODUCT STORAGE ERROR (Bivalent Moderna COVID-19 vaccine Beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-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. On 06-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By DateProduct). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent Moderna COVID-19 vaccine Beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By DateProduct), PRODUCT STORAGE ERROR (Bivalent Moderna COVID-19 vaccine Beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By DateProduct) and PRODUCT STORAGE ERROR (Bivalent Moderna COVID-19 vaccine Beyond 30 days in the refrigerator).    No concomitant product reported by reporter.  Patient received expired Bivalent Moderna COVID-19 vaccine Beyond 30 days in the refrigerator. It was open box of vial size 2.5ml. Vial was initially stored in refrigerator on 29-Nov-2022 and beyond use date was 29-Dec-2022 and it was administered on 06-Jan-2023. Vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.
sz x2-fever 39C;30s episode @ home;4min episode in ER tonic clonic, eyes rolled back, emesis x 1;URI sx x 2-3 days  w/cough;
I received both doses into my left shoulder (4 weeks apart).  Approximately 1 day after receiving my 2nd dose, I noticed that my left arm was becoming increasingly weak and unstable.  I have a history of shoulder dislocations and have had my shoulder surgically repaired in 1997.  Over the course of the next 2-3 days, my shoulder continued to have range of motion issues and felt as if it could dislocate with any ill-advised movements.  I have taken extra precautions to keep my shoulder/arm close to my body to prevent any additional injury.  As of 4/12, (3 days post injection), I still have significant soreness and weakness in the shoulder.
COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved. Not Provided      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  They reported that patient all previous shots were Moderna. They did not have the patient records handy.  Treatment medications were not reported.
Patient given influenza vaccine on 10/8/2018 after already having a dose this season on 9/24/2018.
Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion hospitalization). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.  Company Comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of Herpes zoster, which was severe and required hospitalization. The event occurred at an unknown time after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization.   This case was linked to MOD-2021-425619, MOD-2021-425615 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of Herpes zoster, which was severe and required hospitalization. The event occurred at an unknown time after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization.
Information has been from a family member of a patient with a history of allergies who approximately 05-JUL-2007 was vaccinated with a single first dose of ZOSTAVAX. On approximately 03-AUG-2007 the patient developed shingles. Unspecified medical attention was sought. There was no further information provided. There was no product quality complaint involved. Additional information is not expected.
on 8/3/2020  patient stated she started to have a localized reaction to her shot.  Area is red and swollen when the shot was given.  on 8/6/2020  the patient came by the pharmacy to let us know about the reaction.  I told the patient to take some benadryl and apply a compress to the area to help with the redness and swelling.  Patient's family care dr was notifed.  Also we are going to follow up with the patient in a few days to check on the progress of the reaction
Chills without fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills without fever) and FATIGUE (Tiredness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included FAMOTIDINE, AMLODIPINE, HYDROCHLOROTHIAZIDE, LISINOPRIL, ATENOLOL, VITAMIN B3, SIMVASTATIN and MIRTAZAPINE for an unknown indication.   On 25-Mar-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 26-Mar-2021, the patient experienced CHILLS (Chills without fever) and FATIGUE (Tiredness). At the time of the report, CHILLS (Chills without fever) and FATIGUE (Tiredness) was resolving.            No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Pt. developed hives all over body within 1 hour of receiving 1st GARDASIL.
Guillain-Barre' Syndrome; Initial information received on 05-Dec-2019 and additional information received on 06-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves adult male patient who experienced Guillain-barre' syndrome (Guillain-Barre syndrome), while received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ249AA (Expiry date Apr-2020) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious Guillain-barre' syndrome (Guillain-barre syndrome) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event during 11 days. (hospitalization during 11 days).  Final diagnosis was Guillain-barre' syndrome.   Patient received 5 days of infusion treatment  in hospital.  The patient outcome is reported as recovering for Guillain-barre' syndrome.; Sender's Comments: This case involves an adult male patient who presented with Guillain-Barre syndrome after vaccination FLUZONE HIGH DOSE. Time to onset is compatible with the role of vaccine. However, patient's medical condition at the time of vaccination and lab tests ruling were not reported. Based on available information the role of individual vaccine cannot be assessed.
Case 1 -- Local reddened area 3-4 inches in dia. Red, hot, swollen, and oozing.
Sun 10pm change in taste. Taste continued all day Tuesday. Had COVID test done. It was negative. That evening  his eye started blinking.... Bells Palsey.  Difficulty with face movement. Today still persisting. Now taking a steroid. He is a MD.
This spontaneous report was received from a male consumer of an unknown age reporting on himself. The patient's concurrent condition and medical history were not provided. On 25-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous in his arm (unspecified arm) (lot No. and expiration date were not provided). Concomitant therapy was not provided. The patient reported that after he received the dose of ZOSTAVAX on 25-AUG-2015, he noticed an insect bite on his leg (unspecified leg). The insect bite was treated with an unspecified antibiotic. Since using this unspecified antibiotic the patient's leg had developed a rash approximately at the end of August 2015 (1509USA001246). At the time of the report, the insect bite was not recovered. It was unspecified if lab diagnostic studies were performed. The patient did seek medical attention at an office visit. The consumer did not provide the relation between the insect bite and ZOSTAVAX. Additional information is not expected as no reported details were provided.
Rash; This spontaneous case was reported by an other and describes the occurrence of RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.            Treatment : Therapy with Rybelsus
Patient experienced muscle swelling, pain. Had a bump in the area of the arm where the vaccination was given. Checked with the patient today. Pt is doing ok. Mentioned her pain is gone, still has the bump but much smaller in size. her husband mentioned it is becoming smaller and smaller day by day.
I received the Shingrix shot on a Thursday (7/16/20) and did not have any reaction at all. Upon waking up 5 days later, Tuesday (7/21/20) I started to have intermittent pain on my right side flank. I was hoping it would go away. I woke up early the next morning (7/22/20) in excruciating pain on my right side. It felt like someone was stabbing me over and over and I was bent over in pain. I went to Urgent Care.
24 hours after injection, shoulder, triceps, mid upper arm swollen and pink, mildly tender.
L upper arm - sl tender sl red indurated area lower deltoid area. Not cellulitis  ADVISED TO CONTINUE TO MONITOR AND OKAY TO APPLY HEAT.
Red ring around shot site on left arm, diameter of about two inches. Skin area inside ring is reddish.
testing positive for amphetamine; This is a spontaneous report from a contactable consumer reported for himself. A 27-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 16:50 at the age of 27-years-old (Batch/Lot Number: ER8733) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included stomach pain from an unknown date and colons (as reported).  The patient's concomitant medications were not reported.  The patient reported that he tested positive for amphetamine after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there were reported cases of testing positive for amphetamine after getting vaccinated for COVID 19. He mentioned that he never used any prohibited drugs. He stated he got his first vaccine on 08Apr2021 and like he took around the mid-day then the second day suddenly he went to a sample, a urine sample and somehow it showed there was he tested positive in case, he didn't use drugs and he did not do drugs and anything that it showed he tested positive, he had a word with doctors they said it might be a positive reaction or something but you got to call Pfizer and just tell them about that. He got the vaccine at mid-day like it was around his appointment was 16:50 and he got it that on 08Apr2021 and he did the drug test on 09Apr2021 when he woke up on the next day. The outcome of the event was unknown.  Information on lot/batch number was available. Additional information has been requested.
On Monday 1/30/23 the Pfizer Covid 19 Bivalent for 5-11 yrs was administer to the patient without being diluted first., as a result the patient received a higher than recommended dose.  Post administration the patient complained of burning in 1 eye (he noted this is not the first time he has experienced this symptom) and missed school due to a sore throat on Weds 2/1/23.  Doctor was alerted as soon as the error was discovered and patient/parent advised of potential increase of local and systemic adverse reactions due to the higher dose given, per CDC guidelines the patient will not need to be revaccinated.
w/in min devel swelling of eyes, nasal passages, wheezing & cyanosis was rushed to ER for 02, Adrenalin & steroids;is expected to be hosp overnoc
Information has been received from a physician concerning a 19 year old female with attention deficit/hyperactivity disorder who on 21-JAN-2008 was vaccinated with her third dose of GARDASIL.  The patient experienced transient abdominal discomfort with a prior dose of GARDASIL.  On 26-JAN-2008 the patient was seen for complaints of a sore throat and felt to have neck muscle strain accounting for her pain.  On 29-JAN-2008 the patient was seen again for chest pain and light headedness.  An electrocardiogram (EKG) was normal.  Pain seemed to be musculoskeletal in nature (costochondritis).  Anti-inflammatory agents were prescribed, which the patient did not take, but instead went to the emergency room for narcotic analgesics.  The physician does not feel that these complaints are related to GARDASIL, but rather to heavy lifting (patient works in a nursing home).  The patients outcome is unknown.  Additional information has been requested.
Decedent was  reportedly feeling unwell with respiratory complaints for several days to week prior to death, progressively became more ?wiped out? and tired, staying in bed most of the time. She was found unresponsive in the bathroom where she was pronounced dead by EMS.  Autopsy confirmed bilateral pulmonary thromboemboli as cause of death, with multiple risk factors including obesity (BMI 46.9), recently sedentary, COVID-19 and Influenza vaccinations, and Desogestrel/ethinyl estradiol
In December of 2021, I noticed I had a enlarged lymph node under my right arm. It does not hurt, it's a hard knot on the underside of my arm. It's about half inch large and quarter inch wide. I went to the doctor for a mammogram and ultrasound. They saw nothing and the technician told me it was likely the vaccine. It  is still there I believe it has gotten smaller.
infection; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient resided in an assisted living facility. The patient experienced infection on an unspecified date with outcome of unknown.    Information on the Lot/Batch number has been requested.
20 days after the first dose I experienced dizziness every time I stand from my seat, haven?t experienced this so often, still happens but not every time now. Since May 12 I am experiencing a very strong pain on the top of my right foot that started waking me up in the middle of the night for 3 days in a row, after that I?ve been feelin so much pressure in my right leg, I believe is related to blood circulation, and I even felt a strong pressure at the back of my neck. On May 14 I bought Diosmin Hesperidin over the counter, and children aspirin, I?ve been taking that since that date, it has improved very little, I can?t tell any difference. I have never experienced anything like this before, and I am very concern of a stroke or blood clog.
back pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN LISPRO (HUMALOG) for an unknown indication, LEVOTHYROXINE.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment heating pad was taken.
expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
NOT FEELING GOOD; NAUSEOUS; EXHAUSTED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and other pre-existing medical conditions included patient changed medication from one anti-anxiety medicine to another anti-anxiety.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced not feeling good. On 2021, the subject experienced nauseous. On 2021, the subject experienced exhausted. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling good, nauseous, headache and exhausted was not reported. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about December 2015, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 20-MAR-2016, the patient was treated by a physician for ophthalmic shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Upon internal review ophthalmic shingles was considered medically significant. Additional information has been requested.
Developed oral allergy syndrome secondary to worsening seasonal allergies. These symptoms developed several months after the original injection in the form of seasonal allergies. Despite wearing N95 face masks, patient still experienced worsening allergic rhinitis with no relief from OTC medication including daily Benadryl use. On July 22 of 2023 these allergies expanded to foods when patient ate an apple and developed severe swelling in the upper throat and mouth.
Erythema, induration and blistering at immunization site 24 hrs after given.
After 2nd vax had typical flu like symptoms for 48 hrs but the headache never left. It?s 6 weeks now.
Patient received Covid 19 vaccinations  on 6/23/2021 and on 7/14/2021 without immediate complications. He developed fevers  on 8/23 and was diagnosed with multifocal pneumonia, severe anemia, and hepatitis with elevated AST/ALT and INR  on 8/30. Subsequent work-op including imaging with PET-CT , bone marrow biopsy, and liver biopsy revealed severe autoimmune hepatitis based on massive lymphoplasmocytic hepatic infiltration by histology,  elevated serum  IgG and ANA. He was treated with prednisone and rituximab.  His condition is currently improving, The degree of liver infiltration with lymphocytes and severity of hepatosplenomegaly is atypical what I usually see in new diagnosis of autoimmune hepatitis.