chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no other AEs reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 29-JUL-2021, the patient was vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (1 injection, lot # 1581027, expiration date 03-JUN-2021; strength, route of administration and anatomical site of vaccination were not reported) for prophylaxis (expired product administered). No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1581027; expirationdate: 03-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Red, swollen spot on arm starting 2 inches below injection site. Spot is about the size of a hand.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are deemed viable at the time of vaccine administration.  Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted pfizer to obtain expirations dates directly from them.  No adverse reaction reported from the patient at the time of vaccination. No adverse reaction reported since the administration of vaccination.
Pt reported arm pain late on 11/5/13 worsening overnight. Pt was directed to the ER on 11/6/13 where he was diagnosed with cellulitis and given clindamycin. Pain worsened overnight and pt returned to ER on 11/7/13 and was admitted and hospitalized until 11/9/13 for severe cellulitis in the arm.
On 1/8, developed diarrhea, nausea, stomach upset. Called in sick on 1/8. Symptoms improved 1/10. Developed pruritus on legs, arms and posterior neck; on 1/10/2020; cannot recall time. w/ scratching becomes red. Took Benadryl last night which caused her to sleep. She reports that she had COVID PCR test performed today through CU, in the bldg. denies other symptoms, SOB, wheeze, rash. recommend that she follow-up w/ her PCP, allergist.
Fever of up to 104.5  lasting for 16 days, fatigue, rash, anemia, bloody nose, muscle/joint pain.
PC: fever to 101. Per pt, pain, warmth, redness at sight slight swelling at *:30 am . Temperature 100.0. Positive myalgia. Erythema and small nodules at injection site.
Patient completed two Moderna vaccines in February 2021. She developed a productive cough, fatigue, headache, and fever after exposure to her positive family member. She used home covid test and resulted positive on 12/20/21. Her symptoms were not improving, and she noted low oxygen saturation at home. She came to ED on 12/22/21 and was admitted for shortness of breath and hypertension. She received one dose of Remdesivir and IV/PO steroids. She stayed afebrile and hemodynamically stable. She was discharged home with home oxygen on 12/24/21.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:29 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month. On 03-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow up received contains Non Significant Information
Feelings of something pinching her all over, it was a nerve ending effect; Feverish; Chills; Second dose given past day 35, she received her second shot outside of the recommended time frame because she could not get time off from work; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Second dose given past day 35, she received her second shot outside of the recommended time frame because she could not get time off from work), SENSORY DISTURBANCE (Feelings of something pinching her all over, it was a nerve ending effect), PYREXIA (Feverish) and CHILLS (Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083821A and 083821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and SPIRONOLACTONE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose given past day 35, she received her second shot outside of the recommended time frame because she could not get time off from work). On an unknown date, the patient experienced SENSORY DISTURBANCE (Feelings of something pinching her all over, it was a nerve ending effect), PYREXIA (Feverish) and CHILLS (Chills). On 22-Jul-2021, INTENTIONAL PRODUCT USE ISSUE (Second dose given past day 35, she received her second shot outside of the recommended time frame because she could not get time off from work) had resolved. At the time of the report, SENSORY DISTURBANCE (Feelings of something pinching her all over, it was a nerve ending effect), PYREXIA (Feverish) and CHILLS (Chills) outcome was unknown.            Concomitant product information also included an unspecified allergy medication.  Treatment information was not provided.   This case was linked to MOD-2021-276530 (Patient Link).
Approximately 12 hours after injection, developed "pressure in head".  24 hours, "slight weakness" muscles esp legs.  48 hours: temperature - 102 with "light flashes" both eyes.  72 hours, decreased weakness, flashes decreased.  On day 6, minimal weakness.  No HA, no spots/flashing.
08/24/2023  Noted itchy rash at her left upper back and left upper extremity .  She denies burning in the area.  The patient states she noticed it while running cross-country.
R09.02 HYPOXIA 3/27/2023 SMALL BOWEL OBSTRUCTION
On the day of the vaccine, I started my period early.  The flow appears to be normal however, the day after I got the vaccine I had some of the worst cramps I have ever gotten in my life. I have only had very mild cramps, if any, over the last year or more. And I only remember more serve cramps once or twice over the last 4+ years. They were so bad I had to stop what I was doing, go home take 1000mg of tylenol and lay down. The pain only started to subside about 1 hr after I tool the tylenol and had a heat pack on my abdomen. The pain started to come back 2 hrs after I took the tylenol. I eventually feel asleep. I appear to be much better this morning but can still feel some tension in my abdomen. Have not taken any meds.  My period does vary some. Over the last 9 months (not including the one that just recently started) I average 25.44 days in between. Going back 9 months , time in between in days: 27, 25, 22, 24, 24, 28, 23, 30, 26. This last one that started the day I got the vaccine was only 19 days from the last one.
Patient reported having rash on his legs that started around bedtime the day flu shot was administered.  Had mild redness at injection site with no to minimal swelling.  No reports of fever, rash near injection site, or breathing issues.
Patient with history of COVID-19 vaccination admitted to hospital with COVID-19 detected PCR. Provider d/c note: " 47 YO male with a past medical history of IgM gammopathy in July 2022 after evaluation of neuropathy, Waldenstrom macroglobulinemia and non-hodgkin's lymphoma that presents to the emergency department with complaints of fever as high as 101F at home with body aches, sore throat, diarrhea and nasal congestion. Patient reports having 3 episodes of diarrhea yesterday. Patient recently traveled after seeing his hematologist. Patient resides but has a summer home elsewhere. Patient reports last Chemo therapy of Bendamustine/Rituximab on 6/1/2023.  Patient started to recover as the fever was controlled. Patient was afebrile for > 24 hours and he was discharge in stable condition."
Red bumps/hives on face. Not itchy or painful, but warm to the touch and hives/bumps are slightly raised and pink/red.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 13:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to possibly penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metronidazole (MANUFACTURER UNKNOWN) and daily multivitamin (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. On 14Apr2021 at 23:00, the patient experienced red bumps/hives on face, not itchy or painful, but warm to the touch and hives/bumps were slightly raised and pink/red. The patient took OTC benadryl but bumps were still present 8 hours later. The patient continued to treat with benadryl. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included the treatment with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red bumps/hives on face, not itchy or painful, but warm to the touch and hives/bumps were slightly raised and pink/red was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse referring to a 33 years old female patient who was not pregnant. The patient's concurrent condition included allergy with erythromycin and penicillin. The patient had no medical history or concomitant therapies. Information about the patient' concurrent condition was unknown. On 31-OCT-2018, the patient received her first dose of GARDASIL 9 (0.5 milliliter, lot # R023608, expiration date 30-APR-2021; strength and frequency were not provided) intramuscular for prophylaxis (reported as prevent against human papillomavirus (HPV)). On an unknown date in 2018 (reported as an unspecified time after receiving), the patient developed numbness in her right arm. On 06-DEC-2018, the patient went to hospital due to the numbness and an ultrasound venous doppler was performed of the right arm. The result of the ultrasound showed a deep vein thrombosis (DVT) in her right brachial artery. The patient was not admitted to the hospital and was prescribed XARELTO 15 mg (unspecified frequency). The nurse stated that the patient would be following up with an unspecified vascular surgeon due to the DVT on an unspecified date. At the time of reported, the patient was still experiencing numbness in her right arm, that was determined to be significant disability by the reporter. The outcome of the numbness in her right arm and DVT in her right brachial artery was reported as not recovered. The causality for the events was not reported. Upon internal review, DVT in her right brachial artery was determined to be medically significant.
parent returned to clinic approx 10 minutes p/vax recvd stating pt was passing out; pt was alert & responsive in clinic; planned to call EMS to transport pt to ER: mom stated would rather drive over to hosp; seen in ER w/hyporesponsive, hyp
Approximately 24 hours post vax, the patient developed a high fever that resulted in a febrile seizure.
Severe and acute pain in joints, hands, knees and feet. But now has chronic pain all other the body except face and top of head.
Pt developed a fever (105 or more) and then a seizure. He was treated for the sizure at a different facility.
Difficulty in swallowing; face red; Arm of injection hardly to move; Arm of injection hardly to move; A spontaneous report  was received from a 63 years old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events difficulty in swallowing, face red, pain, arm of injection hardly to move.  The patient's past medical history included anaphylactic reaction and the patient was allergic to codeine flu shot and shellfish. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029LA0A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On 28 Jan 2021, after the first dose of vaccination, the patient could not swallow water, face turned to be red and her arm of the shot was sore till the point that she hardly cannot use it. On the same day the patient went to Emergency Room, they gave her a medicine (unspecified medication) to relax.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event's difficulty in swallowing, face red and arm of injection hardly to move was unknown.; Reporter'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.
PATIENT RECEIVED VACCINE AT ABOUT 409PM. FELT FINE STANDING UP AND HEADING TO WAITNG AREA. WHILE GIVING ANOTHER VACCINE TO DIFFERENT PATIENT, SAID PATIENT WALKED OVER STATING HES NOT FEELING WELL. TOLD TO HAVE A SEAT,LESS THAN A MINUTE AFTER CHECKED ON PATIENT AND HE STATED HE FELT NAUSEAOUS AND NEEDED A TRASH CAN. GRABBED TRASH HEADING BACK OVER ASKED IF PATIENT ALSO FELT DIZZY PROCEEDED TO GET WATER FOR PATIENT WHEN HE PASSED OUT OF CHAIR FACE FIRST ONTO FLOOR. YELLED FOR EMS TO BE CALLED AND PROCEEDED TO TURN PATIENT OVER. HE THEN BEGAN TO WAKE UP. HE SAID HE FELT BETTER AND WAS FULLY CONSCIOUS. CHECKED PULSE SEMI NORMAL HE LAID ON THE FLOOR FOR A LITTLE BIT LONGER THAN WANTED TO SIT IN CHAIR. EMS ARRIVED AND STATED HIS HEART RATE WAS LOWER THAN NORMAL AND TOOK HIM TO HOSPITAL
An 8 year old patient received GARDASIL, HPV vaccine. Patient did receive the vaccine. Merck is researching & will let us know if dose will count. Private office. Human Papillomavirus vaccine. GARDASIL, Injectable; 0.5mL human papillomavirus vaccine. Have one age range recommendation for the HPV vaccine (11-26years). The statement that the vaccine can be given as young as 9 years, increases chance of error. No adverse reaction noted. Error discovered with scheduled appointment for dose 2 of HPV vaccine.
Initial unsolicited case received from a consumer via other company Pfizer under the Manufacturer Report number: 2017058504 on 23 Feb 2017. This case involves 3 patients (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date after the vaccination, the patients are sick with flu. It was reported as the patients received the flu shot every year and every single year they were sick with flu. The patient's lab tests and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
PERIPHERAL NEUROPATHY 11/20/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a medical assistant refers to a 71 years old female patient with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot number 672932/0599AE) (dose not provided) maybe intramuscularly at her left arm on 12-JUL-2012. No other co-susects were reported. No concomitant medications were reported. On 12-JUL-2012 the patient developed "extreme pain" radiating down the left arm that was vaccinated. The vaccination may have been given intramuscularly, however the medical assistant was not sure from looking at the injection site. The patient had sought medical attention via seen in office and no treatment was given for the adverse event. The outcome of extreme pain radiating down the left arm that was vaccinated was reported as not recovered/not resolved. Additional information has been requested.
Parent of child requested pfizer covid vaccine. Parent stated child is 12 years old. We adminstered pfizer covid vaccine ( ndc 59267-1000-03  0.3ml) which had EUA for 12 and older.  On Monday 12/6/21 when we are processing the paperwork for billing we discover the patient is only 11.5 years old. We called the parent and left a voicemail to call us back. adverse status unknown
Tested + for COVID via home kit on 10/17.  Scheduled for monoclonal antibody but condition worsened. Present to medical center on 10/21 with worsening dyspnea, cough, and fever. Started on dexamethasone and remdesivir. O2 requirements increased and started on baricitinib.  Hx DVT on warfarin with D-dimer 0.42 and low risk for DVT.  Bridged to enoxaparin. Increased confusion and mental status changes during hospitalization consistent with delirium. Not tolerating  po meds secondary to cough and high aspiration risk. Maxed out on Vapatherm with O2 saturations in the 80's. Family decided to transition to comfort care with DNR.
I received the Tdap vacc 7/18/08 approx 10:30am by above person at the time vacc was given I told her this was a very painful shot.  That evening at 9:00pm my arm was swollen, red at injection site and painful to the touch.  Before going to bed that night I had developed a temp of 102 degrees E.  By morning I woke up temp decreased but couldn't move or use arm for 4 days and I felt like I had the flu as well for 4 days.
tension headache in the lower back area of her head;; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure.; Constant headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698066.  A 30 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 24Oct2021 13:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TENSION HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "tension headache in the lower back area of her head;"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), MUSCLE TIGHTNESS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "described as above her neck; kind of a tingling and numbness while at the same time feeling tight and has pressure."; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Constant headache". Therapeutic measures were not taken as a result of tension headache, paraesthesia, hypoaesthesia, muscle tightness, musculoskeletal discomfort, headache.  Additional information: Family Medical History Relevant to AE(s): None. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. History of all previous immunization with the Pfizer vaccine considered as suspect: N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Since having been administered the first dose she has been getting reported events. She woke up in the middle night and the headaches were there. She went to sleep and woke up and the headaches were there. Constant headache: Began either one week or two weeks after the first dose. Serious: no. Patient was asking if this was normal with the Pfizer Covid Vaccine, because she was scared to get another dose relative to this event and wanted to call or see a doctor before getting the second dose to make sure it was not going to get worse. AE(s) require a visit to: Emergency Room and Physician Office: No. Investigation Assessment: No. Relevant Tests: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Anxiety, pneumonia , tremor right leg and right arm, weight loss, fatigue,, bronchiectasis/MAC, urinary urgency, Hypertension, constipation, Multiple hospital visits, inability to walk,  parkinson?s, metastatic adenocarcinoma uterine spindle cell
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning an 82 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.