chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 045C21A, 011A21A and 016M20A) for COVID-19 prophylaxis. Patient had never been diagnosed with/ tested positive for COVID-19. No medical history was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Sep-2021 at 12:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:15 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). The female patient was not pregnant. No concomitant medication was provided by the reporter. It was reported that, expired vaccine was administered to the patient; the health care professional thought that Moderna had an extension like Pfizer and assumed vaccines would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022. The used vials were placed refrigerator on the same day of administration (07-Jun-2022) and vials did not undergo any temperature excursion. Event did not cause the patient to seek medical care. It was unknown if there were any other potential causes or patient experience similar events in the past. No treatment medication was provided by the reporter.
Initial serious case received from a physician via health authority on 19 Jan 2011: This patient with unknown medical history received influenza virus vaccine (batch number and manufacturer unknown) on left upper arm on 01 Oct 2009. The patient developed wound on the upper arm. Also it was stated that the patient developed basal cell carcinoma at the application site. No event onset dates were reported. The histology examination was performed on an unknown date but no results were reported. Outcome of the events was reported as unknown.
ADMITTED 12-22-22  FOR HYPERCALCEMIA WITH METS TO THE BONE (HAD H/O BREAST CANCER)   SHE TESTED + FOR COVID DURING THE HOSPITAL STAY ON 1-5-23 .   SHE WAS TRANSFERRED TO HOSPICE DUE TO HER CONDITION.
Red hot muscle and joint pain throughout body most of the night starting at 1:00 AM, finally letting up some at 5:30 AM.  Still was hurting more than normal throughout the next day (SAT), but slept very well that night, although Sunday I still wasn't back to normal.  I'm filling this report out on Wed, and still feel some tiredness, but the muscle pain is back to my normal fibromyalgia.  I don't believe I will be getting another booster in future.
Vitals Written @ 16 Aug 2007 1630 PDT HR: 104, RR: 24, WT: 35 lbs, Tobacco Use: No, Alcohol Use: No,  Pain Scale: 0 Pain Free   SO Note Written @ 16 Aug 2007 1631 PDT Chief complaint  The Chief Complaint is: Rash after vaccination today. History of present illness   The Patient is a 2 year 11 month old male.  2.5 yo boy with his mom: initially received called at 1600, spoke to mom about what was going and asked to have child brought in for examination.  Patient received what is believed to be Chicken pox vaccination this am, after he woke up from his nap this evening c/o of itching all over the abd and lower extremity, at no time was in respiratory distress, still being himself, laughing and playing. No change in PO intake.  Just wanting to itch the rash.  o Pruritus which is generalized. Allergies   No allergies, no allergy to foods, no known drug allergies, and no allergy to animal dander. Past medical/surgical history  Reported History: Reported medications: Not taking medication which has been reconciled with DD form 2766, and includes the following meds: Diagnosis History:  No asthma.   No eczema  No urticaria.   No anaphylaxis Review of systems  Systemic symptoms: Not feeling tired or poorly and not feeling tired (fatigue).  No fever and no chills. Pulmonary symptoms: No cough and no wheezing. Gastrointestinal symptoms: No nausea, no vomiting, and no diarrhea. Skin symptoms: Rash: multiple, generalized, spot: multiple, papule: multiple, and generalized. Physical findings  Vital signs: ° Normal (Reviewed). ° Current vital signs reviewed.  ° RR was normal.  ° PR was normal. General appearance: ° Awake.  ° Alert.  ° Well developed.  ° Well nourished.  ° Well hydrated.  ° Healthy appearing.  ° In no acute distress.  ° Not acutely ill. Nose: ° No nasal discharge seen. Pharynx: Oropharynx: ° Tonsils were not enlarged. Neck: ° Demonstrated no decrease in suppleness. Lymph Nodes: ° Cervical lymph nodes were not enlarged bilaterally.  ° Submandibular lymph nodes were not enlarged bilaterally.  ° Not tender. Lungs: ° Respiration rhythm and depth was normal.  ° Respiratory movements were normal.  ° Clear to auscultation.  ° No wheezing was heard.  ° No rhonchi were heard. Cardiovascular system: Heart Rate And Rhythm: ° Normal.  ° Heart rate was normal. Heart Sounds: ° S1 normal.  ° S2 normal. Abdomen: Percussion: ° Abdominal percussion was normal. Palpation: o Abdomen was not soft.  ° Abdominal palpation revealed no abnormalities.  ° No abdominal tenderness.  ° No mass was palpated in the abdomen. Hepatic Findings: ° Liver was normal to palpation. Skin: o Showed erythema.  o A wheal was seen.  o Urticaria.  ° No cyanosis.  ° No cyanosis of the hands and feet.
Slight fever, then fainted, fell hit head and had jerking back and forth, no continue, of stool then was fine.
Body aches; muscle aches; extreme fatigue; nausea; joint pains; headaches that become migraines; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 12Sep2021 at 12:00 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and did not usually have known allergies. The patient did not take any concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Sep2021, the patient experienced body aches, muscle aches, extreme fatigue, nausea, joint pains and headaches that became migraines. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events body aches, muscle aches, extreme fatigue, nausea, joint pains and headaches that became migraines was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
heaviness and burning in chest, tingling/burning/stabbing pains all over skin, red lesion on center of lower back- felt like WORST SHINGLES ATTACK I'VE EVER HAD and I HAVE HAD THE SHINGRIX VACCINE!, 101 fever, body aches, muscle soreness, fatigue.
THE DAY AFTER THE INJECTION THE AREA WAS RED, ITCHY AND SWOLLEN WHICH I KNOW IS NORMAL. TWO WEEKS AFTER INJECTION MY ARM IS STILL SORE, VERY RED, WARM TO THE TOUCH AND THE REDNESS HAS GROWN FROM A SMALL AREA RIGHT AROUND THE INJECTION SITE TO AN AREA LARGER THAN MY HAND.
On 1.7.21 my arm began to hurt by that evening my arm began to swell.  On 1.8.21 it had swollen significantly and had extreme pain. About day six it started to feel a bit better.  A week and a half later it still had a large hard knot at the injection site by 1.16.21 it started to itch. On 1.17.21 it began to itch really bad and swell  and get hard again, that evening I used topical Benadryl and hydrocortisone which made the itch dissipate slightly.   On 1.20. the swelling is noticeable from six feet away and can be seen popping up under my shirt sleeve.  I made an appointment with a doctor for 1.21.21.
Pharmacy inadvertently sent expired covid vaccine to our facility for administration on 2/15/2023; which was unknown by our facility until 5/2/2023.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age with no known allergies. On 29-AUG-2012 at 15:48 PM, the patient was vaccinated with the first dose of PNEUMOVAX23 IM, lot # H013581 the right deltoid (dose not reported). On 29-AUG-2012, the patient experienced local reaction - pain, swelling and redness. During the call the evaluate it was stated that signs and symptoms were improving. The outcome of the adverse events was reported as recovered/resolved on an unknown date. This is one of several reports from the same source (MARRS # 1211USA001592, 1211USA001593, 1210USA013157, 1302USA012880). Additional information is not expected.
The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023; No adverse event; Moderna Bivalent vaccine was administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day use by date), PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-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 03-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after 30-day use by date), PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (Moderna Bivalent vaccine was administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vaccine was stored in fridge on 24-Jan-2023 and administered on 03-Mar-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient did not report any side effects. No treatment information was provided.
Pt. reported adverse event much later after vaccination date bc scheduled to receive 2nd dose this week.  Says about an hour after vaccine, her eyes were watering.  Later that evening, they continued to water excessively and had a burning feeling.  All this resolved on it's own after 3 days.  She did not call to report earlier bc it was over the weekend and symptoms did improve.  She did also say several weeks later she made an appt with her regular eye doctor to check if there was any lasting damage which he said he did not see any.  Lyndia did also report some tenderness in the arm but it also resolved on its own after 2-3 days.
Patient began noticing in the afternoon sore muscles and pain increasing throughout the day.  He could not "use that arm very well" for about 24 hours.  Still reports some soreness though much improved.  Noted ASA with help.  No swelling, warmth or erythema noted at the injection site per patient.
Pt recvd vax 20NOV92 & 24 hrs p/vax pt exp rt upper quad pain, arthritic pain, loss of appetite, flu-lke sx, numbness in limbs & tingling in fingertips, tenderness & distension in abdo, pulsations in spleen, hyperactive reflexes;
Lot# 053E21A administered outside the 30-day use by date.  A case was opened with Moderna ID Case ID CEA-1261. "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
The patient was vaccinated with the first does of varicella virus vaccine live on 09/18/2000. Subsequently, the patient experienced slight redness. The redness was resolved in 2 days. The patient experienced redness and tenderness after the second dose of vaccine. There was no resolution after 48 hours. Medical attention was sought. No further information is available.
Fever, malaise, joint pain, headache, and pain for two days. Injection site swelling for four days so far. Red, tender hemispherical mass the size of a softball  in my left axilla.
The pt experienced a swollen left deltoid that was tender with itching down to the elbow. This lasted approximately 1 week.
10 minutes after shot throat was itchy, 30 minutes after shot throat was more itchy and broke out in hives across chest and outside of throat
Itchiness and redness of the vaccine site.  Cold pack applied.  Vital signs within normal limits. After 26 minutes they removed the cold pack. Five minutes later the site was no longer red or itchy.
Rash on entire body starting on left arm.  Then moving up the neck to face and legs with minimal swelling. Physician recommended otc Benadryl for 48hrs every 6hrs.
This spontaneous report as received from a health department administrator refers to a 18 year old patient. On 2015 the patient was vaccinated with GARDASIL dose 1 for prophylaxis. On 08-JUL-2017, the patient returned to the health department for the second dose of their HPV vaccination series with GARDASIL 9. The outcome of inappropriate schedule of drug administration and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration to be not related to GARDASIL 9 and GARDASIL. The reporter considered interchange of vaccine products to be not related to GARDASIL and GARDASIL 9. Additional information has been requested.
What feels like anxiety attacks (Heart racing, Throat feels closed up) happen everyday usually. sometimes occur multiple times a day usually at night or late afternoon. After the first dose they started small and got bigger and more frequent after the second shot they have become smaller and a little less frequent but still occur. I should note that I used to have anxiety attacks 5 or so years ago just like this but have since stopped having attacks all together up until my first shot
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a by a healthcare provider. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live ( ZOSTAVAX).  Additional information has been requested.
Patient experienced a full syncope event after receiving his first Pfizer COVID vaccine.  Pharmacy contacted EMS and patient was monitored for 30 minutes and left on his own accord (with a parent)
pt states she has sore left arm around the injection site and looks like she had two injection marks.  Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
Pt recvd MMR vax 3JUN92 & recvd 2nd dose of Hep B vax 24JUN92 & on 1NOV91 pt devel mild diffused lymphadenopathy in the cervical region; swollen lymph nodes were under 2 cm in size; pt had no addt; sx;
After immunization baby had been fussy and subsequently probably 8-10 hrs later started moaning and groaning next for 12 hours; Not breast feeding well; hence was seen in office 24 hours later  without any significant findings
Lightheaded. Nasea. Fatigue. Vommiting. Chills.
Symptoms (Nausea, Joint Pain, Diarrhea, headache, Fatigue) which started after receiving the first of 3 shots in 2000, continued after this the 2nd shot.  After this shot, the level of fatigue worsened. Recommendation : AVA exemption, To continue treatment with current providers to facilitate continuity. Review of ER and Hospital D/C Summary confirms diagnosis of strep pneumonia and past history of hypertension. This hospitalization was several months after dose # 3 of Anthrax vaccination. When this report came in, the date in Box 10 was not specified. The patient had 3 doses of Anthrax vaccine and when the case was typed up, the date of dose # 2 (3/31/00) was chosen for Box 10. Pneumonia did not develop until January 2001, four months after dose # 3 (9/20/2000).
I got the vaccine I just start having issues with my knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPATHY (non-serious), outcome "unknown", described as "I got the vaccine I just start having issues with my knees".   Additional information: Patient reported that during the COVID time, got the first vaccine and then the other two later. Patient was trying like, patient does not remember that the patient has vaccine card and since patient has got the first vaccine it was 2020 probably or does not remember exactly but some months after patient got the vaccine, patient just started having issues with knees but now after three years they found that the patient has arthritis and did not have a problem with the patient's knees, any problem in the patient's body. So, the patient was concerned how can the patient complain or ask questions that patient has right now because it's weird. The patient was 43 years old and now the doctor says that it was really not coming case that patient got this arthritis having right now and the patient was in pain everyday so the patient found now that it's not just the patient, many patients and the internet that they say probably the vaccine that they got for the COVID.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300340085 same patient and drug, different dose and events;
Severe diarrhea 10 stools per day,  started 8/18/23, lasted 11 days. Diaper rash. Supportive care, oral hydration OTC topical ointments
pt recv vax 15DEC98 & became back w/excessive vomiting, fever, gen malaise that lasted 1wk;
patient became pale,coughed, and vomited after leaving exam room (had not been crying or upset during immunization procedure)
Wednesday - 12/29/21 Day of Vaccine - One hour and 20 minutes after vaccine - Nausea and vomiting , muscle spasms to arms and legs Could not drive home from a store - called wife to pick him up. Placed heating pad on at home - drank 2 sport drinks for hydration. Fell asleep. After 2 hours awakened with visible muscle spasms to arms and legs. Right forearm is swollen.  Thursday - 12/30/21 - Muscle spasms continue - fell putting pants on. Went to local Emergency room at 0630 - Was given Ativan, Tylenol and Ibuprofen and a nausea med.  Friday - 12-31-21 - In bed all day - muscle spasms continue - nausea continues -  Saturday 01/01/22 - Out of bed - eating lightly - spasms continue Sunday 01/02/22 - Nausea - eating lightly - spasms less - continue Monday 01/03/22 - Went to work - eating lightly - spasms continue Tuesday 01/04/22 - AT work - eating lightly - spasms continue. 1"-2" red blotchy patches form on arms and legs. Ate a full meal. Wednesday 01/05/22 - At work- faint red patches remain to arms - left swollen forearm is new symptom. Spasms continue. Feeling ill. Recommend going to ER or Personal Physician. Left work in stable condition per self. States he is OK to drive himself home or to the doctors office
headache; sore arm; fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, pain in arm and fatigue. On an unknown date, the outcome of the headache, pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm and fatigue to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had issue with the vaccine and experienced sore arm, fatigue and headache. This case has been linked with US2021AMR001169 reported by same reporter, same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001169:Tdap vaccine, same patient
Myalgia, Arthralgia, Fever, chills Narrative:  Other Relevant History:
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of patients received doses of GARDASIL (dose, route and indication not reported) and PEDVAXHIB (dose, route and indication not reported) that were stored improperly. No concomitant medications were reported. Additional information has been requested.