chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unfortunately we did use this beyond the use date of 10/9/21.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown age and gender. Current conditions included immunisation. Information on patient's medical history, historical drugs, drug allergies and concomitant medications were not reported. In approximately 29-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, anatomical location, lot # and expiry date were not reported) for immunisation. On the same day (reported as "immediately") after the vaccination, the patient began to bleed profusely from the injection site for a few minutes. The patient did not received any treatment. No overdose and cancer was reported. The pharmacist stated that she controlled the bleeding with napkins. On approximately 29-NOV-2018, the patient got recovered (reported as when the patient left the pharmacy the patient got recovered and no longer bleeding was there). Causality assessment was not provided. No Product Quality Complaint (PQC) was reported.
DX: Allergic Reaction, redness, swelling at site of injection warm to touch pain at site of injection. Benadryl - cool compress
Severe shoulder pain/ joint pain in both shoulders; Hard for her to sleep; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (Hard for her to sleep) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (Hard for her to sleep). At the time of the report, ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (Hard for her to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt stopped having stools @ approx 3mos; would not have BM for 5-7days w/o rectal stimulation; stools were runny & full of mucous; fully tested for Hirschsprung's disease (barium enema & rectal bx -  neg for Hirschspring's);
about 5min p/vax eyelids swollen & red, devel sl wheezing & coughing;tx w/epi, DPH
Multiple red blanching some slighlty thick red patches and macules all over but mostly on his trunk on extremities. He has it too on his palms and soles. No felt swelling at this time. Some patches are dark reddish on the left anterior thigh. No purpura, no petechia noted. Mother is concerned his rashes have spread. He has fever for 2 days now. He is itchy. He almost had anaphylaxis.
He was given Meningococcal conjugate in error. He already got a dose on september 2022. No adverse reaction observed. Patient alert and oriented. Stayed for 15 minutes observation
Pt describes total loss of muscle control for 3 days post vaccine starting the night of vaccine. Pt reports incontinence as well. Pt reports he had the same reaction for the last 4 shots
This spontaneous report was received from a medical assistant, refers to 4 patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, four patients were administered improperly stored doses of PNEUMOVAX 23 (dose 0.5 ml after the temperature excursion reported on 22-SEP-2014. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Patient stated his arm started to itch the evening of the vaccines and he developed welts all over his upper and lower arm. His arm turned purple but he feels it may have been from scratching the itch. He came to the pharmacy the day after and was advised to take BENADRYL.
Rash in left hand from the knuckles above the wrist  red  with whelps and itchy.
presents w/parotitis 2wk p/vax;mom claims cough (non prod) & low grade fever began day p/vax & has cont;
pt recv vax & 4hr later pt had 1min episode of stiffening, glassy-eyed staring then gen tonic-clonic movements of all extremities w/duskiness of face;sx stopped;resolution of cyanosis;pt was sleepy next 2hr;
Significant swelling and redness of leg in which DTAP was given. Area of swelling was the lateral aspect of the leg, from hip to knee. Swelling and redness persisted for 4 days.
This spontaneous report as received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. On unknown dates, the patients were vaccinated with 0.5 ml doses of GARDASIL (lot # not reported) intramuscularly that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a pt who experienced a streptococcal septicemia infection and developed a response to only 3 or 4 of the serotypes. The pt received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day IM. Concomitant medication were not reported. A physician reported that the pt received all 4 doses of Prevnar and developed a streptococcal septicemia infection (pneumococcal sepsis) (drug ineffective). Date were not provided. Antibody level testing determined that the child developed a response to only 3 or 4 of the unspecified serotypes but not to those remaining (decreased immune responsiveness). Pt recovery status is unknown.
Death Certificate 4/22/2021  Cause of Death - Hypertensive Cardiovascular Disease
Headache; Chills; tiredness; Sore; Felt not well; injection site is painful; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported for a 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318) at 59-year-old as single dose for COVID-19 immunisation. Medical history included ongoing diabetes. Concomitant medication included metformin taken for diabetes. The patient got the first dose on 02Feb2201 and on 03Feb2021 been experiencing headache, chills, tiredness and injection site was painful. Consumer stated, "she got the shot on 02Feb2021 and on 03Feb2021 patient just at all days then she having headache and chills. I noticed "possibility" (not clarified) sore but her question was can patient take like Ibuprofen or something to deal with the headache". Consumer stated, "on 02Feb2021 she got (received vaccine) and this morning (03Feb2021) during the class time. She just felt not well. She calling to see if I can take Advil or ibuprofen for the headache down." When probed still having the problems, consumer stated, "(Yes)." Consumer added, "she just need to know she can take ibuprofen for this headache to "cool down" (not clarified). Outcome of the event headache was not recovered and all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Limiting effect on mobility; Pain in ankle/ leg pain; Chills; Restless/tired; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restless/tired), MOBILITY DECREASED (Limiting effect on mobility), ARTHRALGIA (Pain in ankle/ leg pain) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE, METOPROLOL and HCTZ for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced RESTLESSNESS (Restless/tired) and CHILLS (Chills). On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOBILITY DECREASED (Limiting effect on mobility) and ARTHRALGIA (Pain in ankle/ leg pain). The patient was treated with VITAMIN B6 at a dose of 1 dosage form and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) ongoing since an unknown date at a dose of 1 dosage form. On 12-Apr-2021, CHILLS (Chills) had resolved. On 15-Apr-2021, RESTLESSNESS (Restless/tired) had resolved. At the time of the report, MOBILITY DECREASED (Limiting effect on mobility) outcome was unknown and ARTHRALGIA (Pain in ankle/ leg pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood test: negative (Negative) Performed a blood clot test which returned negative.         Treatment information included Vitamins prescribed by neurologist.  Patient was referred to a neurologist who also performed a number a tests, with all returning negative. Patient stated neurologist began her on a vitamin regimen, but she has not seen any relief so far.  Patient said that she went to the doctor and gave her vitamin B6 , B12 and folic acid to take. She said her legs are doing better. Dr. said she may need physical therapy.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow up information was received on 8 May 2021: updated event - Mobility decreased, added the outcome of the event leg pain as not recovered, added lab test and concomitant medication. Patient had been to her Primary Physician and Neurologist. On 03-Aug-2021: Follow-up information received contains updated outcome of the event leg pain as recovering, updated concomitant medications
2 x 2 cm area of redness and swelling x 2 days. 200mg Motrin and 20mg Benadryl given in office. No fever;normal pulses and resp.
Received shingles vaccine 6-13-13 Rt arm - Quarter size redness developed 6-15-13 getting larger by 6-20-13. Hot to touch. No itching or soreness fatigue off and on.
Severe chills - worst of my life Lasted for 12 hours Woke up at 3 AM with them and they suddenly disappeared 12 hours later, and I felt fine
vaccine was administered 3 inches below the bottom of the deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered 3 inches below the bottom of the deltoid muscle) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 1995. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Hypertension, GLUCOSAMINE and COLECALCIFEROL (D3) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 02-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered 3 inches below the bottom of the deltoid muscle). On 02-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered 3 inches below the bottom of the deltoid muscle) had resolved.            No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: the follow up were received on 03-MAY-2021. the updated information includes:patient demographic details were updated.action taken was updated.medical history was updated.concomitant medications were updated.second vaccine dosage was updated.
It started out with diarrhea for 3 or 4 days, chills, sore throat, upper respiratory symptoms, slight cough, fatigue, running nose, and weak. I went to an urgent care clinic, and they tested me for strep and COVID-19. I tested positive for COVID-19 and negative for strep. They prescribed me an oral steroid and it helped with my sore throat. I saw my doctor 03/20/2023 for a regular visit but I was still feeling tired and unwell. She told me to rest.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not reported. On 12-APR-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (25/0.5) (units not reported) (lot# K008927, expiry date: 17-MAR-2016, dose: 0.5 ml, intramuscularly). Concomitant therapy was not reported. No adverse effects was reported. Additional information has been requested.
pt recv vax 12SEP96 & that evening pt exp fever & nausea;13SEP96 pt devel a rash around the lower leg, waist & trunk which itched;rash was described as pimple-like areas not typical of chickenpox;By 18SEP96 pt had completely recovered;
Severe headache and fatigue and sore right arm at injection site. Took an  Excedrin Day 3 no symptoms .
Nausea, 24 hours profusely sweating, 10 minutes headache, started 30 minutes after receiving injection, lasted 6 hours pain to elbow, 24 hours Sleepiness, tiredness, 30 hours
patient get  sick from flu shot; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got sick (illness) while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication 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 got sick from flu shot (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 19-FEB-2016 the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot#, K007243, expiration date 13-DEC-2015; dose and dose number were not reported, oral). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Covid 4/28/22 Acute on chronic respiratory failure with hypoxia 4/28/22  Currently still admitted but planning a discharge to a Skilled Nursing Facility. 5/5/22
Local reaction in left thigh where vaccine was administered including large red spot that has grown since it started, tenderness, fever, and achiness.
This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient did not have any drug reactions/allergies. On 16-DEC-2017, the patient was vaccinated with a dose of VARIVAX (dose, units, frequency not reported) lot # N014631, expiration date: 11-MAY-2019 via subcutaneous route and a second dose on 18-JAN-2018 (dose, units, frequency not reported) lot # N014631, expiration date: 11-MAY-2019 via subcutaneous route. On an unknown date, the patient was found to be pregnant (exposure during pregnancy). The last menstrual period (LMP) was 30-NOV-2017 and estimated date of delivery (EDD) was determined to be 06-SEP-2018. No known adverse effects were reported (no adverse event). It was unknown if any lab diagnostics/studies were performed. The patient did not require any intervention. The events did not result in any significant disability/incapacity or hospitalization. No further information was provided. At the time of the report the outcome of pregnancy was unknown. No product quality compliant (PQC) was present.
used a vanish point syringe and the vaccine leaked out of the side while I was administering.  I offered to revaccinate since I am unsure how much liquid came out but patient declined
MODERATE LEFT AXILLARY PAIN WORSENS WITH ARM MOVEMENT  MODERATE LEFT  CERVICAL PAIN AND LEFT SHOULDER PAIN
ILLNESS, LOWER ABDOMINAL PAIN, LOWER BACK AND UP SIDES  - IN AND OUT OF DR.'S APPT. AND MEDS. FINALLY DIAGNOSED WITH NON-HODGKINS LYMPHOMA AROUND 6/6/2021 AND BEGAN CHEMO 6/28/2021. DECEASED FROM "NEUTROPENIC FEVER" (NOT OFFICAL AS THEY HAVE YET TO PRODUCE A DEATH CERTIFICATE.).
This spontaneous report as received from a physician refers to a couple of nurses of unknown age and sex. The physician reported that he had heard from a couple of nurses that they had completed the vaccination with RECOMBIVAX HB (lot#, expiration date and route not reported). On an unknown date, as a child. As they entered the nursing school they had their titers checked on an unspecified date and were found that the hepatitis B titer was low and they had to be re-vaccinated. No concomitant medications were reported. Additional information has been requested.
Neck pain; Fever; Headache; Chills; Redness; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events neck pain, fever/pyrexia, headache, chills, redness/erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) via unknown route for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient experienced the event(s) neck pain, fever, headache, chills, redness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), neck pain, fever, headache, chills, redness was unknown.
The same day post vax, this pt experienced acute tetany, and her whole body went ridged. The pt was sent to the ER. As of 01/31/00, the pt had recovered.
Received vaccination March 29th, 2021, I started getting COVID symptoms headache, fever, body aches, extreme fatigue, Diarrhea, May 9th, 2021. I Called my PCP and they directed to go to the Urgent Care to get checked out. They did a physical Exam, COVID test, and Influenza A-B tests, both came out negative. ER determined that I was diagnosed with "Acute Upper Respiratory Infection - Encounter for Screening COVID-19," nothing too bad. My PCP just wanted to check that I did not have COVID and to check out all the basis. I was in the ER for about an hour and then went home.  I self isolated for 2 weeks, symptoms lasted for about a week.
Patient's daughter reported 3 days after vaccination that the patient has extensive bruising at the injection site indicative of a hematoma as well as itching at the site of injection. Patient reports have pain and issues with the itching around the injection site also. Advised patient's daughter to take OTC medication appropriate for her elderly age as well as to be cautious when taking Benadryl for itching  (potentially harmful drug for elderly patients per List) and to monitor for side effects. Patient's daughter will monitor the situation and will report back if things do not improve within two days or a week time interval.
Pt. states she's not had full use of her (L) arm since she received the influenza vaccine, no redness, swelling or visible abnormalities. States arm is fine from elbow down. All the pain in her shoulder. States she can't reach back with her arm.
1 DAY AFTER IMMUNIZATION, PT STATED SHE FELT SORENESS. 2-3 DAYS POST SHOT NOTICED REDNESS AT INJECTION AND INCREASE IN BRUISING ON SKIN AND AT TIME OF OBERSVATION SIZE SLIGHT BIGGER THAN HALF-DOLLAR COIN. STILL SORE. PT TAKING TYLENOL AND COLD COMPRESS FOR PAIN RELIEF.
tired; slight headache; felt achy, had a sore arm; slight fever; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tired), HEADACHE (slight headache), MYALGIA (felt achy, had a sore arm) and PYREXIA (slight fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced FATIGUE (tired), HEADACHE (slight headache), MYALGIA (felt achy, had a sore arm) and PYREXIA (slight fever). On 29-Apr-2021, FATIGUE (tired), HEADACHE (slight headache), MYALGIA (felt achy, had a sore arm) and PYREXIA (slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not mentioned. Treatment medications were not provided   This case was linked to MOD-2021-186933 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.