chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reconstitution with sterile diluent; Reconstitution with sterile diluent and administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA721A, expiry date 30th September 2023) for prophylaxis.   On 12th January 2023, the patient received the 1st dose of Menveo. On 12th January 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date :13 JAN 2023 Reporters comment: The reporter was registered medical assistant. The reporter stated Menveo was reconstituted with a sterile diluent instead of the supplied diluent and was administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. Additional supportive information: As patient received sterile diluent instead of the supplied diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient was administered a concentrated dose of 0.2mL vaccine.  No adverse effects noted.
Narrative:  COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/19, Pfizer, dose #2 07/13 COVID swab, result: not detected 08/31, Pfizer, dose #3 09/18 SARS-COV-2 Variant Sequencing result: pending 09/18 COVID swab, result: detected 09/21 pt cc: chills, cough, diarrhea, fever, loss of taste or smell, myalgias, headache, fatigue, exposure: unknown 09/27 pt admit to medicine cc: covid, hypoxia dx: covid 19 pneumonia LOS: 4 days 09/27 CXR impression: Several EKG wires overlie the chest. There is a right internal jugular port catheter with tip in the region of the right atrium. An aortic valve stent graft is again seen. The heart is magnified by technique. Patchy bilateral alveolar opacities are seen distributed throughout the lungs, worrisome for Covid pneumonia. The visualized pleural spaces are well preserved. 09/27 CTA PE impression: 1. Negative for pulmonary embolus. 2. Known Covid pneumonia with diffuse groundglass infiltrates similar to chest radiograph performed earlier today. 09/27 US EXTREMITY VENOUS LTD impression: No evidence of acute or progressive deep venous thrombosis bilateral lower extremities. Chronic appearing nonocclusive/recanalized thrombus left popliteal vein initially imaged 10/2/2017 09/27 TROPONIN I <0.016 09/27 procalcitonin <0.05 09/27 ESR 31 09/27 DDIMER 7.00 09/27 bnp 51.7 09/27 ABG: i-pH 7.50, i-PC02 31.4, i-P02 73; i-HCO3 24.3 09/28 lactic acid 1.07 09/28 procalcitonin <0.05 09/28 FIBRINOGEN 469 09/28 DDIMER: 4.02 09/28 ESR 22 09/29 FIBRINOGEN: 342 09/29 DDIMER: 4.24 09/29 ESR 13 09/30 FIBRINOGEN: 250 09/30 DDIMER: 3,32 09/30 ESR 6 10/01 FIBRINOGEN: 226 10/01 DDIMER: 4.75 10/01 ESR 1
Pt. developed an injection site reaction characterized by a 10 cm area of redness and pain, the day following the injection.
Day one: Excessive sleep. Low grade fever at evening/night (not over 100,4). Nausea.  Fatigue. Tinnitus.  Body and headaches. Day three:  All above continue.  My entire left side started to appear heavier than the right, and I started to lose balance to that side.  5 rashes in one hand and 6 in other popped up.  March 31: I seen Dr,  first time.  He described at the after-visit summary: "Had Moderna covid vaccine march 3, the next day for the past month has been having off and on low-grade fever, weakness, skin eruption, loss of balance " April 6:  wrote to my doctor complaining about brain fog, which comes with blurry vision.  Episodes come in spells of hours to days.  During these episodes, I can't solve logic tests. But after it passes, I became near normal, a bit slow thinking.  Had a consultation on this day, and he described at the after visit summary: " Continue to have weakness after 2nd dose covid vaccine on March 3 2021 , off and on low grade temp , skin peeling both hands" April 15. Started to feel anxious and depressed for not being able to work. See the doctor.  He described: "She continue to feel weak , low grade temp after covid vaccine last month , not able to work in school , feels depressed , used to take Prozac that worked for her , no suicidal or homicidal ideation ." I started to take prozak 20mg and it made me feel better.  April 15, visit the doctor to see the growing lesions on my hands.  April 29, visit the doctor to see progress of the lesions May 12, Visit Dr for the firs time. She prescribed: ibuprofen (ADVIL,MOTRIN) Meclizine (ANTIVERT)  ondansetron (ZOFRAN) . May 19. Visit Dr with terrible nausea and fever that still continue every night plus all other symptoms she prescribes tramadol. it didn't help, only the anhistaminic seems to help.  May 21, I remembered I had toxoplasmosis with uveitis, and called dr to report and asked the titles. She gave me referral for an CTSCAN and MRI, ENT, and infections diseases specialists.  Because CT scan could be scheduled only for June 10, and because I was feeling I was going to die with all this symptoms, she suggested for me to go to the ER. I was reluctant because I didn't have $ to pay, But ended up going on May 26. CT Scan was normal, and they couldn't perform the MRI.  June 2- I see the ENT, DR. He ordered ENG and audiology.  June 7- Audiology: Pure Tone Audiometry:   Mild sensorineural hearing loss at 250-500 Hz. Rising to normal 1000-4000 Hz. Sloping to severe hearing loss at 8000 HZ. ENG: "Abnormal ENG-findings consistent with peripheral vestibular dysfunction (unilateral weakness to the right) Abnormal ENG-findings consistent with central vestibular dysfunction if occular motor dysfunction can be ruled out. (Vertical nystagmus and abnormal oculomotor tests)" June 13: Scheduled to see a neurologist.
Patient developed slight droop of the right side of the face 27 days after vaccination. Patient also has some numbness of the right side  upper lip. Denies other symptoms.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ with a Lot # reported as L033543 with an expiration date of 30-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that from 23-DEC-2016 to 31-DEC-2016, the vaccine was exposed to a temperature of 32 to 36 Fahrenheit degrees range (0 to 1 Centigrade degrees) for a time frame of 177.5 hours (for 6 cycles); from 03-JAN-2017 to 31-JAN-2017, the vaccine was exposed to the same temperature for a time frame of 464.5 hours (for 21 cycles); from 02-FEB-2017 to 28-FEB-2017, the time frame was 409.5 hours (for 16 cycles) and from 01-MAR-2017 to 15-MAR-2017, the time frame was 61 hours (for 6 cycles). The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004439: US-009507513-1704USA004438: US-009507513-1703USA010028: US-009507513-1704USA004437.
Patient received the first dose of covid vaccine on 4/9/2021.  Patient had also received the different manufacturer COVID vaccine the day before on 4/8/2021.
Flu coming on; Sore arm; Did not feel quite right/feeling funny; This is a spontaneous report from a contactable consumer via Medical Information Team. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for COVID-19 immunization. Patient stated that he received the first dose of the PFIZER BIONTECH COVID-19 mRNA VACCINE 3.5 weeks ago and the second dose last Wednesday (21Apr2021). Patient stated that after the first dose he had a sore arm, stated did not feel quite right, nothing major, like the flu coming on but no fever, stated feeling funny. Patient stated that nothing happened to him on the first, second or third day after the second dose of the vaccine side effect wise noting nothing like on the first dose. Patient stated he was concerned about the second dose not going in because he is not having any side effects. Patient stated the nurse stung him the first time and said nothing is coming out and the nurse stung him again and the patient stated he felt wetness on his arm. Patient stated the nurse did not squeeze up his arm and put it right in.  Patient stated the nurse said to him she did not like the "syringes" and the patient is thinking that the needle was bent. Patient stated he asked the nurse did everything go in and the nurse told him yes and sent him on his way. Patient stated his wife and mother had the second dose and had the same symptoms but stronger than the first dose. Patient stated his wife had the second dose Saturday and reported soreness stronger than the first time and body ached a little bit, not feeling ok, nothing major, patient stated yesterday her arm was still a little sore but today she is better. Patient reported his mother got the second dose on Saturday and reported about the same as his wife noting soreness in the arm and pain in the legs stating it is gone now. Patient stated he is not happy about the answer he received and stated he did not want to report anything to DSU. Patient hung up on agent before any demographics could be obtained, side effect reports verified and survey offered. Patient asked is there a test for antibodies to see if his vaccine worked. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a physician and described the occurrence of arthritis in a 59-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline). Concurrent medical conditions included chronic pain, degenerative arthritis, joint pain and low back pain. Concurrent medications included PERCOCET, CIPRO, PROVIGIL, PHENERGAN, NEXIUM, MAVIK, EPIMORPH, SENNA, Vitamin D (5000 units), Vitamin B Complex, One-a-day vitamins, Baby aspirin, Iron, CITRACAL + D, DHEA and Vitamin B-12. On 15 October 2010 the subject received a dose of Flu vaccine (unknown). On 16 October 2010, 1 day after vaccination Flu vaccine (within 24 hours of receiving Flu vaccine), the subject experienced severe arthritis. The subject was treated with Prednisone taper. At the time of reporting the event was unresolved. the physician considered the event was possibly related to vaccination with Flu vaccine. It was reported that the Flu vaccine was not administered at the office reporting and the reporter did not know the contact information of the facility at which the vaccine was given. No lot number of expiration date were known. The exact vaccine that was given was not known (FLUARIX or FLULAVAL), just that it was a GlaxoSmithKline flu vaccine. The subject was referred to a rheumatologist.
improperly stored vaccine administered; NO adverse effect; This spontaneous report was received from an office manager refers to a patient of unknown age.     The patient's medical history, concurrent conditions and concomitant medications were unknown. On 08-JUL-2019, the patient was vaccinated with one dose of improperly stored (Product storage error) therapy type of digital data logger rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R025713 exp.date: 20-JUN-2020) (strength, frequency, anatomical location was unknown) for prophylaxis. No adverse events was reported. The vaccine was stored at a temperature of 33.9 Fahrenheit for a time frame of 20 minutes. There was a previous temperature excursion of 30.3 Fahrenheit for 93 hours and 50 minutes. The outcome of product storage error and no adverse event was unknown.
This spontaneous report was received from a 66 year old female patient. The patients medical history included knee replacement surgery in the past and shingles in 2006. On an unknown date in 2008, the patient was vaccinated with first dose of ZOSTAVAX (lot number, expiry date was unknown) and patient had no adverse effect reported. On 25-SEP-2013, the patient was inadvertently vaccinated with dose 2 of ZOSTAVAX (lot number, expiry date was unknown). On 25-SEP-2013, within two hours of vaccination the patient experienced some swelling around the site of knee replacement. There was no treatment rendered for the event. The outcome of the events were unknown. Additional information has been requested.
arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization.  Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol.  The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy.   The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."
No adverse event; 1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.   No Medical History information was reported.    On 21-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (1 patient received a bivalent Moderna COVID19 vaccine as a primary series dose, first dose).    No concomitant medication information was provided.  It was unknown that patient was received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.
Risen appeared on right arm, not on the sight of infection. A rash is surrounding it and it is painful and red. It is also causing some itching.
Neurologic disorder. Daughter reported that 4-7 days post vax, her mother developed severe neurologic side effects. She reportedly experienced double vision, cannot move head, neck or shoulders, cannot lay down, sit up, walk or drive a car. She has been hospitalized and to the emergency room several times.
Swollen, red itchy eyelids, ears and hands 10 minutes after vaccines. No respiratory or GI symptoms.
RN administered Boostrix Tdap Vaccine  Lot: 7535X Exp. 02/15/2015 on 03/12/2015. Vaccine was administered after expiration date. No signs or symptoms noted, Patient was made aware, and was revaccinated on 03/16/2015 with Tdap vaccine with Lot: 65030AA and Exp. 05/01/2017 by BSN RN.
Pfizer 3/32/21, 4/13/21. Positive on 8/2/22
testing positive for COVID after getting the vaccine; testing positive for COVID after getting the vaccine; This is a spontaneous report from a contactable Other Health Professional reported for herself.  A female patient of an unspecified age (reported as 42) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after getting the vaccine in Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included COVID test in Dec2020: negative; positive. The reporter would like an explanation as to the rapidness of her testing positive for COVID after getting the vaccine. Can the vaccine cause false positive test results?  Information on interpretation of SARS-CoV-2 test results. The patient tested negative on Monday, got the vaccine on Monday. However tested positive today, asymptomatic.  Information about batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recvd vax 9AM 10OCT94 & late that afternoon about 5PM rt ear begin to feel stopped up & BY 8PM pt could not hear at all from rt ear; seen by MD 17OCT94 for ear problem tx w/no improvement; pts ear roaring sound & edema (inside ear);
Headache along with blurred vision and numbness on left side of face.  Has history of migraines, but this was different and has now persisted longer than one week.
Headache, Myalgia, arm soreness Myalgia, headache, arm soreness; taking tylenol, motrin. States he feels like he is "having a malaria attack."
Complaint of radiating discomfort down arm immediately after vaccination, but denies pain.  Patient also complained of headache. pO2 97%,  BP 122/80, pulse 71, respiration 20, SpO2 97% All symptoms completely resolved during triage (by 2:24pm)
Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. Pain under left side of breast bone and shoulder blade.
PT'S WIFE CALLED ON MONDAY STATING THAT THEY WERE ON THE WAY TO THE ER THAT HE HAD A FEVER IN THE ARM AND REDNESS. THE ARM HAD A RED LINE RUNNING DOWN THE MUSCLE IN THE ARM AND SWELLING. PT DR SAID HE HAD CELLULITIS AND SENT HIM TO TH ER AT MEDICAL CENTER HE WAS ADMITTED WITH A STAPH INFECTION, GIVEN ANTIBIOTICS AND IS DUE TO BE REELEASED TODAY. PT WBC 2 PLATELET COUNT WAS 75 RED BLOOD CELL COUNT WAS ALSO LOW AS WELL.
11/17/11 1345: Client had flu shot this afternoon (1315 hrs), 1st flu shot ever; waited in Health Unit waiting area x 15" after inject no symptoms, after returning to office began feeling tingling in (L) back & then some tingling in lips & tongue, VSS. HR 120, BP 124/90 R 12 on return to H.U. at 1340. Tx with BENADRYL 25mg 1 PO now. 1400 VS. repeat  120/90 HR 112, R 12-14 no wheeze, SOB, no swelling of mouth, lips or tongue.
Received Adacel 5-30-07 in L deltoid. since that time has had increasing pain in L upper arm/deltoid region radiating to neck. Muscle spasms in neck and weakness L arm referred to PCP.
Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2016488442) on 14 Nov 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Tetanus Diphtheria Pertussis Vaccine) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient had developed allergies to Tetanus Diphtheria Pertussis Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of the documents held by sender: none.
Abdominal pain, diarrhea, weight loss, rash on arm, fever. Diarrhea, abdominal pain, and weight loss persisted. Hospitalized on 9/27, diagnosed with Ulcerative Colitis, total Colectomy with end ileostomy on 10/26.
Per Dr visit/note: This is a little interesting that it is 3 days out from his vaccination initially and he had not had any issues prior to this morning.  I wonder if this is a type IV delayed hypersensitivity reaction.  After discussing with my nurse who gives lots of childhood immunizations, this likely was the Kinrix vaccine given IM in the left anterior thigh.  There is no evidence of acute infection at this time other than the erythema and the warmth but there is no fluctuance.  My suspicion is that the most likely diagnosis is hypersensitivity reaction although infection is not entirely ruled out.  He has no systemic symptoms at all at this time, no fevers or chills.  He is moving the joint above and below this area fine without any issues and there is no lymphangitic streaking.  I do not see an indication for blood work at this time today but if this progresses, there is lymphangitis type symptoms or he seems to be progressing I of course would recommend immediate return for further evaluation.  For now I recommend antihistamine, ice and compression to see if this will help reduce some of the response that he is having.  I want this rechecked in 24 to 48 hours as well.  Mom was comfortable with this plan.  Patient is brought in by his mother today for evaluation of significant swelling and erythema noted in an injection site from his 4-year-old vaccines.  He received his vaccines on Monday 4/26.  Mom did not notice any immediate reaction.  He complained slightly that day of some discomfort and pain in his left leg but it was not anything that was limiting his activity.  Mom gave him a shower last night and did not notice any redness or swelling that was apparent.  When he got picked up from preschool this morning he told his mom that his leg hurt and so she pulled down his pants to look at his leg and noticed that it was substantially erythematous, firm to the touch, warm and she was very concerned of possible infection.
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: about 1 minutes after covid 19 Pfiezer 5-11 yrs vaccine, patient complains of nausea. look pale on face. no fever. sweat a little bit. patient is responsive. Blood pressure was 58/43, heartbeat 55. mother was give her a sip of drink which she brought with her. After 15 minutes blood pressure was taken again at 91/77. heartbeat 84. patient looks almost back to normal.
Very strong leg pain  the following day that lasted two weeks.  Chest pains and trouble breathing  started on Sunday April 4th and continue today.