chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. A male patient (age unknown) received a dose of PREVENAR 13 on 23Dec2010 in his right thigh. The patient was also administered SYNAGIS on 23Dec2010 for RSV prophylaxis. Relevant medical history and concomitant medications were not provided. The patient's mother noted swelling at the injection area in the immediate period following the vaccine. Within 7-10 days of the vaccine being administered, the area became very noticeable. It was described as a large mass in the right thigh that had slightly grown since the vaccine was administered. The reporting physician feels he has possibly ruled out SYNAGIS as the cause of the mass due to zero reports of injection site reactions from the manufacturer of SYNAGIS. The reporting physician stated that this mass does not display the typical injection site reactions so they are unsure if it could potentially be a sarcoma they are dealing with. The patient has a consultation scheduled with an orthopedic surgeon on 12APR2011 and he may have an MRI at that time. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Chills, body aches and headache. The headache lasted from late Saturday night/ early Sunday morning until late morning on Thursday, 6/24.
3AM t103.4 ax; 7AM t102.4 ax; 3PM 102.4 ax; vomited 12PM had eating-drinking well;
My skin became hypersensitive about 24 hours after my vaccination.  I was in a lot of pain, it hurt to sit or touch anything.  I felt like I had a fever but a fever did not register when I checked it.  This lasted around 14 hours or so.
Started to have a headache approximately 2 hours after vaccination progressed the next day to severe headache, body aches, took TYLENOL OTC for headache and body aches.
2th dose received after 12 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2th dose received after 12 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2th dose received after 12 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2th dose received after 12 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
I was administering the vaccine in child's left thigh . Sibling interfered and pushed the plunger. More than half of the vaccine dibbled down into child's thigh . Approximately o.1 ml was left in the syringe.  The child was revaccinated with no issues.
Soreness and swelling redness at injection site. Took ALEVE three times. Soreness continues on third day.
A large red raised rash 3"X2.5"  appeared on my left deltoid 24 hours after the vaccination. It was hot, somewhat painful, and itched. This was my second Moderna injection. I had no reaction at all after the first one.
Had a month long itchiness in the left arm with the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Had a month long itchiness in the left arm with the 1st dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Had a month long itchiness in the left arm with the 1st dose). At the time of the report, PRURITUS (Had a month long itchiness in the left arm with the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
9 days after Varicella Vaccine given, he developed a cough.  On the 10th day after vaccination (12/28/07), he was diagnoesd with pneumonia and hospitalized overnight.  Also diagnosed with RSV and Influenza Type B.  1/8/08 Reviewed hospital medical records which reveal patient experienced cough, congestion, irritability, reduced oral intake x 5 days & developed dehydration.  Admitted 12/31/2007-1/1/2008. Tx w/antibiotics. FINAL DX: RSV, Influenza B & dehydration.
Injected with a long needle that hit her bone; Most of the content of the syringe spilled out; Most of the content of the syringe spilled out; A spontaneous report was received from a consumer concerning a female patient of unknown age. The patient had her second dose of the vaccine and she was injected with a long needle that hit her bone and while the nurse who was administrating the vaccine tried to pull out the syringe, most of the content of the syringe spilled out.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on an unknown date.  The patient received their second of two planned doses of mRNA-1273 (batch number not provided) in the for prophylaxis of COVID-19 infection.    The agent said the patient had her second dose of the vaccine and she was injected with a long needle that hit her bone and while the nurse who was administrating the vaccine tried to pull out the syringe , most of the content of the syringe spilled out. She is not sure if she needs to get another short or not.  Treatment information was not unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided.   The outcome of the events was unknown.; Reporter's Comments: This report refers to a case of wrong technique in device usage process, underdose, and device connection issue for mRNA-1273 (lot# unknown) with no associated AEs reported.
This spontaneous report was received from a pharmacist, concerning a 36 year old female patient. The patient did not have relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 23-MAR-2018, the patient was vaccinated with a dose of VARIVAX, 1 ml subcutaneously once, lot # N009768 and expiration date on 24-MAR-2019, for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK). On 30-MAR-2018 (also reported as "after a week later"), the patient developed a lump around the vaccination site, redness and pain. The patient did not sought medical attention, no treatment was given for the event and no lab diagnostics or studies were performed. The patient was not recovered from the events by the time of the reporting. The reporter did not assess the causal relationship between vaccination with VARIVAX and the events.
My first symptoms were heart palpitations and hard to breath for a few hours, low grade fever with aches for 2 days. I?ve been experiencing sudden sharp painful headaches for the past few days.
Pt reported chest pain, flushed in face, tachycardia, hypertensive, and SOB after receiving Pnuemovax 23 injection. Resolved on own after 20mins.
DVT IN BOTH LOWER LEGS; This spontaneous report received from a patient via a company representative concerned a 40-year-old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was otherwise healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose and start therapy date (on an unspecified Friday) were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  On an unspecified date, on Monday the patient sent a photo to his doctor of what was happening with his legs (redness) and on an unspecified date (Tuesday) he was diagnosed with Deep Vein Thrombosis (DVT) in each lower leg. The patient was seen at a hospital (unknown date). The patient was being treated with Xarelto (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of DVT in both lower legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210857658-COVID-19 VACCINE AD26.COV2.S - DVT IN BOTH LOWER LEGS. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
difference more than 35 days between 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (difference more than 35 days between 2 doses) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Patient's medical history is not provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (difference more than 35 days between 2 doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (difference more than 35 days between 2 doses) outcome was unknown.        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.   No concomitant medication was reported . No treatment medication was reported .
Dose administered 20 hours after punctured; Dose administered to 16 year old; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 20 hours after punctured) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 20 hours after punctured) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to 16 year old). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 20 hours after punctured) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  It was reported that vial was initially punctured on 09-Sep-2021 at 3 P.M . It was stored at room temperature post puncture for about 20 hours. The vial did not undergo any temperature excursions.  Treatment information was not provided.
PT RECEIVED INJECTION 8/8/2022 AT ED AFTER LACERATION REPAIR, 8/10/2022, PT WAS SEEN AT URGENT CARE FOR SX THAT OCCURRED 5 HRS AFTER INJECTION. PT REPORTS FEVER, NAUSEA, VOMITING AND DIARRHEA.
Pt. reported that the morning after receiving her 1st Moderna vaccine, she started itching on her neck, then bilateral upper extremities, and is now moving to her back, and the side of her torso.  Pt. administered 8mg Decadron intramuscularly to right upper outer quadrant of buttocks.
+ Ag test 01Jun2022; + Ag test 01Jun2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 17Mar2021 as dose 2, single (Lot number: EL3247) and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "+ Ag test 01Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Received TDaP and Flu vaccine (not sure which-it was preservative free if that helps). About 5 minutes after, experienced presyncope-vision blacking out, slurring words, not able to stand.   About 10 hours post-vaccine, started getting a fever and muscle aches. Lasted for two days. Fatigue is continuing.
Developed temporal arteritis and polymyalgia rheumatic 32 days post booster. temporal artery pain, vision changes, skeletal muscle weakness, severe headaches with neck and shoulder pain, excessive fatigue.  OF note, this person also developed PMR with vision changes 60 days after vaccination of same type  on January 7, 2021 but as the association was not listed in medical literature until recently, the person did not know this was a reaction to the vaccine (or would not have accepted a booster).
Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient stated that he has had a rash on his left arm from injection site to elbow since receiving the Moderna Vaccine.  He requested his second dose be given in his right arm.
Redness, pain, and swelling area near injection site. Allergic localized reaction is cellulitis.
15 min after flu vaccine administered - pt returned to office w/2 red blotches on cheeks. BENADRYL 5 ml given.
SEVERE BACK PAIN; PAIN ALL OVER; MALAISE; WEAK; CHILLS; HEADACHE; WEIGHT LOST; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1888979 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced weight lost. On 04-APR-2021, the subject experienced pain all over. On 04-APR-2021, the subject experienced malaise. On 04-APR-2021, the subject experienced weak. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced severe back pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from severe back pain on APR-2021, was recovering from headache, and weight lost, and had not recovered from chills, malaise, pain all over, and weak. This report was non-serious. This parent/child case is linked.; Sender's Comments: V0-Medical assessment comment is not required as per standard operating procedures.
Hives and rash beginning on 8/29 around 11:00am. It first appeared on the lower leg. By 8:00pm it was on both arms, torso, and back of thighs.  Hives appeared on the chest.
Tiredness; headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 10:24 (Lot number: EN6201) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Open Heart Surgery", start date: 18Dec2013 (unspecified if ongoing), notes: Bicuspid valve; "Aortic Aneurysm", start date: 2013 (unspecified if ongoing), notes: Open heart Surgery, repaired.; "Total Knee Replacement", start date: 2011, stop date: 2015, notes: Total knee replaced Left Knee; "Thyroidectomy", start date: 2003, stop date: Aug2018, notes: Thyroid removed Aug2018; "High blood pressure" (ongoing); "AFIB" (ongoing); "Thyroid" (ongoing); "Heart" (ongoing). Concomitant medication(s) included: SOTALOL taken for hypertension, start date: 2017 (ongoing); METOPROLOL taken for atrial fibrillation, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2015 (ongoing); SYNTHROID taken for thyroid disorder, start date: 2018 (ongoing); ASPIRIN 81 taken for cardiac disorder, start date: 2013 (ongoing); VITAMIN D3, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time:, Date: 16Feb2021, Time: 10:08AM, Site and Route of Injection: , Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN-6201), administration date: 16Feb2021, for COVID-19 Immunization, reaction(s): "Chills", "aches", "Headache", "Stomach Upset", "Tiredness", "Arm Swelling". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 18:00, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset 09Mar2021 18:00, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, headache.  Additional information: no prior vaccinations within 4 weeks. Relevant Tests: the patient had blood work done 3x a year due to heart and thyroid issues. She also had an echocardiogram done yearly since 2013. She had (6) stress tests since 2008. She had numerous MRI's and CT scans due to various issues. There was not enough room to list all of it on this page. This Questionnaire was not for the average person to complete. Most doctors will charge a fee to complete this form and the pharmacists say to see your doctor about this form. You people are not in the real world. Most people would become frustrated and throw this in the trash. Get real. What a joke.   Follow-up attempts completed. No further information expected.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 22, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 22, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Patient states that after every annual flu vaccine she has ever received, she has an asthma attack.  This was the quickest she had ever had one after a flu shot.  After Albuterol MDI, pt was fine after 10 minutes.
The patient developed a blood clot in the left calf 2 weeks after the first dose of Moderna COVID vaccine, which required treatment with Eliquis 5 mg twice daily. The patient also reported hearing loss that needed treatment with a tapering steroid protocol. The sense of hearing did not recover after the most recent loss event.
This spontaneous report as received from a healthcare worker via a company representative refers to a 50 year old female patient. On 25-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # K004487, expiration date 21-AUG-2015, 1 dose once) intramuscularly. Concomitant therapies included TRAMADOL and TYLENOL. On 25-SEP-2014, the patient experienced fever, body aches and cough after receiving PNEUMOVAX23. The patient visited the emergency room (ER) on 25-SEP-2014, but was not admitted and went home the same day. The outcome of the events cough, fever and body aches were unknown. This is one of several reports from the same reporter.  Additional information has been requested.
Pt recvd 2 doses of Engerix-B, 2nd given 26APR91; 24 hrs p/2nd dose exp h/a, aching, t102; 4 days p/2nd dose exp wheezing; 11 days p/2nd dose improved but still having night sweats, fever, muscle & joint aches, SOB, neck  pain;
Pt recd vax 24JUN91 9AM approx 6PM woke up from nap & both eyes & lips were swollen; Spoke w/MD on call who ordered DPH; No further problems now;
Patient had a severe vasovagal episode.  He got extremely pale and fell asleep immediately after the vaccinations were given.  He spiked a fever to 101 and began vomiting that evening.  He was feeling better the following day.
received dose 1 / a half year ago /dose 2/ administered on July 15th 2021.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number K2CG4, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received 1 and a half year ago).   On 15th July 2021, the patient received the 2nd dose of Shingrix. On 15th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 1 dose of Shingrix 1 and a half year ago and dose 2 was administered on 15th July 2021, which led to lengthening of vaccine schedule. The reporter consent to follow up.
A few hours after my 2nd dose of the Moderna vaccine, I began to experience significant fatigue, headache, joint and muscle pain, heat flashes, brain fog.  I began taking OTC ibuprofen/acetaminophen but they didn't have any impact.  The side effects started to diminish about 24 hours later, and now at 36 hours they are almost gone.
This case was reported by a physician and described the occurrence of sweating in a 13-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On the morning of 2 February 2008 the subject received 1st dose of HAVRIX at 0.5 ml in the left arm. An unspecified amount of time following vaccination with HAVRIX, the subject experienced sweating and feeling very tired. This resolved after 20 minutes. Then on the morning of 02 August 2008 (the subject was now 14 years old) the subject received a 2nd dose of HAVRIX at 0.5 ml in the left arm. Immediately afterwards, he experienced tiredness and sweating which lasted 10 minutes. His blood pressure remained within 90/50 (his normal is 110/55). After 20 minutes he felt better and was sent home. His blood pressure went back up to 96/53 (improved). Follow-up information was received on 04 September 2008 via a physician, which conflicted with the initial report. The physician reported that all of the events resolved after 20 minutes, but listed the date of onset as 08 May 2008, which differs from the previously reported vaccination dates. The physician indicated that the events were resolved and were possibly related to vaccination with HAVRIX. In addition, the physician stated that no action was taken other than rest for the subject.