chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache and overwhelming exhaustion of  1.5 days duration starting approximately 1 hour after vaccination.  Lethargy and mental fog of >2 days post vaccination starting 1 hour after vaccination
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19.  Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Patient had vaccine administered on 12-14-11 at 0900 am. Experienced (L) arm pain around injection site to axillary area, radiating to (L) breast, and down (L) arm to fingers. No swelling. Took ALEVE did not help. Pain 7 out of 10. Next day better but still a pain primarily on posterior upper arm and into palm. But was getting better.
I am allergic to it; Initial information was received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care via Social Media.  This case involves a patient of unknown age and gender who had allergic to vaccine (allergy to vaccine), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious allergic to vaccine (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Known allergies: Augmentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Covid 19 treatment, brand: pfizer, treatment start date: 03Oct2022, treatment stop date: 07Oct2022, indication for treatment of Covid-19. Other medication in 2 weeks product is entyvio, start date: 10Oct2022,and stop date: 10Oct2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Inadvertently administered Kinrix instead giving Dtap and IPV separately.  Monitored client for 30mins. Provided education over adverse signs and symptoms to mother.   Gave VIS over Kinrix, Dtap, and IPV.   Mother verbalized understanding.  Made f/u phone call on 1/19/2022 to check on client.  No answer left message to return nurses call.
Patient reported that he developed a rash approximately 24 hours post vaccination. Patient observed to have 5 or less papular lesions across forearms and hands. Patient reported the symptoms 11 days after vaccination date.
Patient arrives to be seen for weakness.  Apparently patient's wife had a difficult time getting him up today and getting him dressed.  Patient does not seem to have any unilateral weakness.  Patient has dementia and his complete history is suspect.  Patient is really not sure why he is here.  Patient does not appear to be in any acute distress he is not seen coughing vomiting etc..
PAINFUL LEFT ARM SINCE VACCINATION.  LEFT ARM IS HEAVY SOME TIMES. SLOWLY GETTING BETTER. DOING RANGE OF MOTION EXCERCISES.
Pt c/o body aches, arm swelling, hot to touch and red in color at injection site.
Patient  developed chest pain 7 days post  first dose of Moderna vaccine administered on 8/17/21. DEVEPOPED CHEST PAIN ON 8/25/21. Was seen in TTA on 8/28/21 for chest pain evaluation.  Had CT angiogram on  8/28/21 which showed a nonocclusive thrombus in posterior descending branch  of right pulmonary artery.  He was started on Eliquis in the ER and is currently on it. Inamte was examined and , we do not see any risk factors for PE other than getting the vaccine recently. Tested negative for covid all the time since last year. Never had covid infection.  Patient is currently in stable medical condition and discharged back to the facility.
Achy to shoulder in arm of injection; Soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy to shoulder in arm of injection) and VACCINATION SITE PAIN (Soreness at site of injection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Achy to shoulder in arm of injection) and VACCINATION SITE PAIN (Soreness at site of injection). At the time of the report, PAIN IN EXTREMITY (Achy to shoulder in arm of injection) and VACCINATION SITE PAIN (Soreness at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Tuesday December 28, by evening time: soreness at injection site (left arm), and mild flu-ish symptoms including freezing hands and feet at first, and freezing body as a whole by midnight. Tylenol helped. Wednesday December 29: Freezing temperatures continued. Injection site pain expanded on the left side to shoulder, chest, neck, and ear. Ear in particular was quite uncomfortable, though in and out. Unusual itchiness in the area of left chest pain, as well. Onset of cold symptoms, including congestion and post nasal drip. Tylenol helped. Thursday December 30: Most pain had subsided by Thursday aside from injection site soreness. Cold symptoms persisted. Headaches began that were like migraines-- throbbing behind left eye, sensitivity to light, limited appetite.  Headaches and cold symptoms persisted through Sunday January 2 (4 days total). Patient tried various forms of treatment in the interim: tylenol (ineffective), advil with increasing dosage volume (moderately helpful, but short-term), and nasal spray to relieve congestion in case it was sinus headache (efficacy unknown). Headaches subsided by Sunday afternoon. Unclear if that was a result of any of the treatments. TBD if headaches will resume on Monday Jan 3.
Transferred from another hospital. Presented there on 7/14/2021 with shortness of breath. While at outside hospital (OSH), pt with BP of 103/54, HR of 65, RR 20.  Upon presentation there, pt with oxygen saturation of 77%.  He was started on Optiflow with 25 L at 85%; pt now with spO2 of 91%.  Pt had elevated D-dimer, so CT angio chest done.  It showed multifocal pneumonia; no PE. He had nl trop and EKG.  Pt was given Azithromycin and Decadron while there.  Request for transfer made given pt's need for Optiflow. When received at our hospital, patient was resumed on dexamethasone, started remdesivir, ceftriaxone and doxycycline. He continued to have acute hypoxemic respiratory distress requiring mechanical ventilation.  Developed septic shock was requiring pressors had low blood pressure and was found to have septic shock from COVID pneumonia, with superimposed likely Gram-negative bacterial infection. received  Steroids, Rocephin, doxycycline, remdesivir.  Received 1 dose of Actemra. Course complicated by rhabdomyolysis, new onset atrial fibrillation. Passed away on 8/16/2021
Very painful at injection site for a month. pain disappeared.  Came back after a month and lasted for a couple of weeks. Disappeared and has returned again as of 8-18-20
Patient presented for first dose of Covid vaccine.  Received Moderna vaccination without incident.  Client was only 15 and error was discovered immediately after vaccination. Father present and apologized to nurse for bringing someone under vaccination age.  Patient left with no adverse reactions. Nurse admitted it was the end of the clinic and very hectic and just did not verify the birthdate. New process has been put in place for all nurses to circle land initial age on paper registration form or write the age on the blue paper used in conjunction with electronic registrations.
Breakthrough case admission after 2 vaccines 1/27/21 Pfizer EL9264 2/17/21 Pfizer EN6201
I developed a large itchy rash on the 9th day, 3/3/21, after my first Moderna dose around the injection site.  On day 10 I also developed same type of rash on the area below my lower back around the cheek area ?sit bone?.   I?m watching to see if it travels anywhere else.   It is somewhat behind my knee as well.  The itch began subsiding two days later but was extreme in that timeframe.   I used Lamisil cream on the areas and it did help.   I also began taking Claritin.  The itch is gone and rash is completely gone on torso and very faded on arm,  3/9/21. I hope you find this helpful.   I?m determined to get my 2nd dose on 3/22/21 even though this reaction is frustrating.
Around 10-10:30pm the evening after I received my shot, I developed a fever.  Despite taking 2 extra-strength Tylenol at 10:30pm, my temperature quickly went up to 104.0° by 1:00am.  My temperature remained elevated through Monday morning.  I was generally achy as well.  By the time I awoke Monday morning, I had developed a rash on my torso (from my chest to upper belly; my lower back & hips; & the inside of my upper thighs).
03/10/2021 Chief Complaint Patient presents with Cough symptoms x 3 days, exposure last week Nasal Congestion, Clinical Support, 3/11/2021, RN COVID-19 virus infection Dx, Progress Notes, (Registered Nurse) Encounter Date: 3/11/2021 Signed. Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions, Instructions, COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide, Office Visit, 3/15/2021, PA-C, Family MedicineSOB (shortness of breath) +2 more, Dx Cough Fever, Shortness of Breath, Reason for Visit, ED, Discharged, 3/15/2021 (4 hours) ED Last attending. Treatment team COVID-19, Clinical impression, Weakness Generalized Chief complaint.
On day 9 following vaccine, developed large (size of a hand) burning rash at injection site. Extreme body (muscle and joint) pain. No fever. Took cleratin, applied ice pack to location with no relief. Now applied an otc topical cortisone cream 1% will see if it helps.
Patient is a 71 yr. old male admitted for Hospital (non-ST elevated myocardial infarction) [I21.4], ACS (acute coronary syndrome) [I24.9, Please refer to the History and Physical report for information on presentation. The patient was admitted. He ruled in for myocardial infarction and cardiology was consulted. He was started on beta-blocker and statin and aspirin and anticoagulated. Subsequently he was taken for angiography. The following results were found: Right dominant coronary anatomy. Left main-0%. LAD-mid 90% stenosis with plaque extending up to the diagonal bifurcation. Distal 30% narrowing.  TIMI-3 flow. D1-small with proximal 40% narrowing. D2-medium size vessel with mid 30% narrowing. Circumflex-proximal 30% supplying a large branching OM. OM1-luminal irregularities up with up to mid 20% narrowing. RCA-dominant vessel with slight luminal irregularity distally. Right PDA-20% narrowing proximally.  Right PLB-30% narrowing proximally. The patient underwent PCI with stent to the LAD and transferred to the floor. I discussed him with Dr. who recommended discharge to home this afternoon. ACE inhibitor
within 12 hours of receiving the second dose of the vaccine I experienced headache, acute body aches, and was bedridden for 24 hours.
Patient given Kinrix  for catch up shots (  Dtap and IPV  )  Which is indicated for age 4-6   patient is age 8 no adverse reaction was indicated.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 120 hours. The lowest recorded temperature was 34 F (1.111111111 celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The schedule for SHINGRIX was 2 doses over 6 month span. The patient had received his 2nd dose of SHINGRIX during the 6 month timeframe and a week or so later developed a case of Shingles which was verified by a physician at a separate location. The reporter did not consent to follow-up.
8 year old female patient who was given an expired dose of IPOL vaccine, with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via other healthcare professional and non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00829525).  This case involves an 8 year old female patient who received expired dose of suspect IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A) for prophylactic vaccination.  On 09-Oct-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1F973M and expiry date: 03-Oct-2021) (Frequency: once) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Nurse Practitioner states a dad just called and said his child was given an expired IPOL. Caller wants to know how soon she can get another one. Additional Description of event adverse events: Patient Information patient age less than year enter as 2 month, 4 month. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for Tuberculosis (TB) skin test 0.5ml o Strength standard except for Fluzone HD (high dose), standard. If baby was delivered: delivery date and if baby experienced an adverse event. Inform that they will be receiving a follow up questionnaire. If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is a requirement".   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 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.
Syncopal event approx 10 min after vaccine administration. LOC for a few seconds. Diaphoretic initially but quickly resolved. Pt admits to no breakfast and no water this AM. Did have coffee.
I don't drink and I don't smoke so I'm not sure why I have an enlarged liver now. I don't really do anything to effect my liver. I don't do any drugs, smoking or drinking. On 05/11/2022 my doctor told me I had an enlarged liver.
clumps of hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (clumps of hair loss) in a 40-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (clumps of hair loss). At the time of the report, ALOPECIA (clumps of hair loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported   No treatment medication reported
Left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) solution for injection, via an unspecified route of administration on left arm on 16Jan2021 09:00 at a single dose for Covid-19 immunization. Medical history was reported as none. Patient has no known allergies. There were no concomitant medications. Patient was not pregnant. The patient received the first dose on 28Dec2020 (lot number: EK5730). Patient did not receive other vaccine in four weeks. Patient has no other medications in two weeks. The patient experienced left axillary lymphadenopathy on 17Jan2021 21:00. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 after vaccination. Outcome of the event was recovered.  No follow-up activities are needed. No further information is expected.
Patient arrived to vaccine clinic accompanied by her husband. Patient received her first dose of the Pfizer vaccine in left deltioid at 1517 and then waited the suggested 15 min in the waiting are post vaccine administration. More than an hour later, staff made RN aware that patient and husband returned and is sitting in vehicle. Upon opening patients door to her vehicle, large amount of vomit was visibly noted inside of vehicle. Patient answering some questions appropriately but then does not answer others. Patient's husband mentioned patient does have mild dementia. No shortness of breath noted nor difficulty breathing. Patient was then transferred via wheelchair into clinic. Vital signs taken. Patient continues to vomit at this time. Ice pack provided. 911 called. Paramedics and Fire department arrived at approximately 1700. Medication administered via paramedics. Patient was then transferred out of clinic via stretcher accompanied by patients husband.
Information has been received from a nurse concerning a 27 year old female, with no pertinent medical history, drug reactions or allergies, who on 25-NOV-2006 was vaccinated with Varivax. Subsequently the patient developed lesions, which were first noticed on 09-DEC-2006. Upon examination the nurse practitioner noticed the patient had five lesions, and the patient mentioned getting new ones. The lesions that first appeared were still vesicular and had not crusted over at the time of this report. The patient was prescribed acyclovir (ZOVIRAX) 800 mg, 5 times a day for 5 to 7 day, along with oatmeal baths and an antihistamine for the itching. No further information is available. Medical attention was sought. There were no lab diagnostic studies performed. The outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Approximately one month after getting my vaccination I developed COVID-19. On 11/12 I began having a tickle in my throat that evening. On 11/13 I woke up with a worse sore throat, fatigue, and congestion. Tested positive on an at home COVID-19 and reached out to PCP. Prescribed steroids and an antiviral. Prescriptions have helped resolve symptoms but some are still lingering.
Redness, great deal of swelling (right arm looked as if a had a huge tumor hanging off it!!), (lasted approx. 4 days). I took a BENADRYL 1 tablet each night at bed time.
Received vaccine 1/5/21. On 1/8/21 she felt dizzy and nauseated and fatigued. Blood pressure, pulse, temperature, O2 level all within normal limits.