chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertent administration of TENIVAC instead of the intended TDAP vaccine with no reported adverse event; Initial information was received on 30-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 25 years old female patient who reported that inadvertent administration of tenivac instead of the intended tdap vaccine with no reported adverse event after receiving vaccines DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE and diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U7183AA via intramuscular route in the left deltoid (Suspension for injection) (with unknown strength., expiry date) for prophylactic vaccination (Immunization).  On an unknown date, the patient received a unknown dose of suspect DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient developed a non-serious event of inadvertent administration of tenivac instead of the intended tdap vaccine with no reported adverse event (wrong product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT, (unknown latency) following the administration of DIPHTHERIA and TETANUS and not otherwise specified PERTUSSIS VACCINE.  Action taken with DIPHTHERIA and TETANUS TOXOIDS (Tenivac) and DIPHTHERIA, TETANUS and PERTUSSIS (not otherwise specified) VACCINE (DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertent administration of tenivac instead of the intended tdap vaccine with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Widespread rash; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 26Apr2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included atopic dermatitis. The patient had known allergies to peanut, tree nuts, coconut and stone fruit allergy (peaches, apricots). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced widespread rash. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of event widespread rash was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
My COVID-19 infection symptoms started on 10/31/2022 in the evening. I had a runny nose, fever, chills, body aches, cough, and tiredness. I took a COVID-19 home test which was positive. After 1 month later I did an online call with a doctor because I still had cough from COVID-19. The doctor recommended to get FLONASE over the counter and to do nasal rinses.
Pt complained of vision changes, specifically sensitivity to light, blurred vision but did NOT have any eye pain or vision loss. Pt began to experience the symptoms the evening (11/8/22) after receiving the 2 vaccines and symptoms have continued until now, 11/16/22.
Information has been received from the mother of a female patient in her "early 20's" with no relevant medical history who on 25-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 mL). There was no concomitant medication. On 25-SEP-2006, the patient experienced "a lot of pain and nausea." The pain was described as a stinging feeling when the medication was being injected. The patient subsequently recovered from the pain and nausea one hour after vaccination. Medical attention was not sought. Additional information has been requested.
This case was reported by a nurse via other manufacturer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had sore, swollen injection site after receiving SHINGRIX. For tolerance to 2nd dose, refer case US2019GSK019571.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: blood clut in the lungs and legs-Severe, Additional Details: Per patient he went to the hospital on 3/17/21 and 3/23/21 and was diagnosed with a blood clut in his lungs as well as his legs. He was treated with Pradaxa but still continues to have difficulty walking and has overal body aches.
56 yo female patient received Pfizer COVID-19 vaccine on 12/18 @10:37AM. About 30 minutes after time of administration, patient had s/s of itching on her scalp, developing rash, and a warming sensation. Patient presented to the ED @11:10AM. Reaction was treated with diphenhydramine 50 mg and famotidine 20 mg in the ED. Patient has had similar reactions with almost every prior vaccination, including yearly influenza vaccine. She was observed for 90 minutes with no new onset of adverse symptoms.
Shortness of breath; Tingling; Numbness of body, face, neck; Tachycardia at 144; Palpitation; Elevated BP at 140/90; Chest tightness; Dizziness; Flushing of face; A spontaneous report was received from a physician, who was a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated blood pressure (BP) at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.     On 27 Dec 2020, three to four minutes after receiving the mRNA-1273 vaccine, the patient experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face. The patient reported the elevated BP was not her usual blood pressure. She underwent an electrocardiogram (EKG)unknown results and was given oxygen for the events. No other treatments were administered.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events, numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face, was considered resolving.; Reporter's Comments: This case concerns a 34 year old female patient, who experienced a serious unexpected event of hypoesthesia and paraesthesia and non serious unexpected events of dyspnea, tachycardia, palpitations, blood pressure increased, chest discomfort, dizziness and flushing. The event occurred within 3-4 min after first dose of mRNA-1273 (Lot# 025J20-2A) vaccine administration. The patient was treated with oxygen and no medication was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My neck swelled up on the inside and it was a really weird feeling. I was having difficulty breathing, it felt like a tube was in my throat. I had a pain going from my neck to the side of my skull. I eventually consciousness. The call center wouldn't let me talk to a doctor. I passed out, and finally was seen by a doctor. When I regained consciousness again, the doctor performed a mini examination on me by feeling the side of my throat. The doctor administered a prednisone shot for me; I took about two weeks to recover from that. I did notice the series of the vaccine that I have extreme heart palpitations and anxiety caused my symptoms to being worse since receiving the vaccine.
My arm broke out in a raised rash near the injection site and stayed for about a week. Never went to the doctor though.
2 days after the second dose, felt pain in right leg during regular morning run.  Patient continued in pain for a month, then went the the Emergency Room in Morristown Medical Center. During the ER visit, DRs saw DEEP VEIN THROMBOSIS , prescribed Xarelto 20MG & 15 MG (2x/day for the first 30 days) FOLLOW UP 9/7/2021 - HAD VASCULAR VENOUS DUPLEX LOWER BILATERAL -  CHECK-UP
Starting the day after the shot and continuing to today, there is pain, stiffness and difficult movement at site of injection
Approximately 3 weeks after receiving my second dose of the Moderna Covid vaccine, I began experiencing episodes of palpitations. I work in healthcare and these appear to runs of PAC?s (premature atrial contractions). To this date they occur all day long. I have never experienced these prior to receiving the vaccine.
Refridgeration excursions identified; No Adverse Event; Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) and NO ADVERSE EVENT (No Adverse Event) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Aug-2022 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 25-Aug-2022 at 3:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units).    No concomitant products were reported.  Anatomical location for vaccine administration was reported as deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07-Sep-2022. The vial underwent temperature excursion. No adverse reactions reported for the patient.  No treatment products were reported.
Severe Diahrea,( Pedialite), headaches (aspirin), Site tenderness, fatigue (sleep)
This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with an improperly stored dose VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
My Asthma has been controlled with occasional flare ups. Three days after the first dose of the vaccine my Asthma symptoms became severe. I could barely do anything. I had to use my recuse inhalers more often but they were not working.  I managed to maintain until I got the second dose and then it got much worse after that shot.  I can  barely talk and some days are very bad. I can't do anything not even my household chores. I need to lay on my side in the recliner to help my breathing. After the second dose I was on 60mg of Prednisone tapering to 40mg after ten days. It did not help with my symptoms at all. I was given Brovana Nebulizer after the vaccine. It did seem to help a little. I am scheduled to see my Pulmonologist.  I have also been dealing with constant headaches and I am laboring for breath all the time. It has been eight weeks and I have had no improvement. I used to be able to simple yoga but now I can never draw in breath.  Pulmonary,  Second Dose 027B21A-04/08/2021
Arm was discolored and peeling; Arm was discolored and peeling; This is a spontaneous report from a contactable consumer (pharmacy intern). A 65-year old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)(PREVNAR 13; lot number: CM1131; NDC number: 00005197102; expiry date: Apr2022) intramuscular, on 08Sep2020, at 0.5 mL, single, for immunisation/vaccination. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine on 08Sep2020, and a day or so later, she came in and stated her arm was discolored and peeling. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Mom reported child screamed off & on for 5hrs p/receiving DTP; MD states probably rxn to dtp wnted child to have ped dt in future;
Pt had moderate to severe periorbital swelling and truncal urticarial rash approximately 3-4 hours after receiving yellow fever (1st shot) and Anthrax #3 both left arm
An employee noticed two unopened vials of lyophilized vaccine component (ActHIB vaccine) without the liquid vaccine component (DTaP-IPV component). We cannot say with 100% certainty which two out of five patients were effected by the error and which MA is responsible. Vaccines with Lot #UJ876AA was entered into (EMR) on 06/21/2023. We narrowed our search down to the five patients that were given the Pentacel after 06/21/2023. Five vials come in a box. Two were missing the liquid component, one was given to a patient on the day the incident was discovered and two remained in the box. According to a report that was pulled, it shows commercial vaccines were given where state should have been given or it was documented incorrectly. An action plan has been put into place to prevent future errors. There will be inventory checks performed bi-weekly with an inventory check list and sign off for accountability. The staff is also keeping a log of vaccine administration to cross check the administration of the vaccines are accurate and match in the EMR. Dr. reviewed the patients chart and she is up to date with her vaccines and revaccination is not required for this patient.
muscle aches; chills; 102.1 degree fever; Moderate headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 (Lot number: FF2593) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cosmetic skin" (unspecified if ongoing); "Hair loss" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LORATADIN taken for hypersensitivity, start date: Feb2021 (ongoing); FINASTERIDE taken for alopecia, start date: Jan2018 (ongoing); TRETINOIN taken for skin disorder, start date: Sep2021 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Anatomical site of injection: L Arm, Route- Intramuscular, Lot/Batch number: EL3247), administration date: 23Mar2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, Anatomical site of injection: Left Arm, Route- Intramuscular, Lot/Batch number: EL3247), administration date: 12Apr2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "muscle aches"; CHILLS (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "chills"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "102.1 degree fever"; HEADACHE (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "Moderate headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, chills, pyrexia, headache.  Additional Information: It was reported that started experiencing symptoms about 10 hours after booster dose. Treated with Motrin every 8 hrs until resolved the next day.   No follow-up attempts are possible. No further information is expected.
Felt achy; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Felt achy) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (Felt achy). At the time of the report, MYALGIA (Felt achy) 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.   Concomitant Product information was not provided. Treatment Information was not provided.
Narrative:  She reports having developed nausea starting the day of the vaccination and lasting for about 3 days, with the second day (described as feeling nauseated with strong-smelling food). She took pepto bismol, which assisted the  nausea, but did not improve her appetite She did not experience other common adverse effects including vomiting and abdominal cramping and was able to drink fluids the entire time.
1/16/22 Mom noted a "right thigh welt" and tiny spot above it. Photo by mom showed an area of redness + 2 red bumps that faded over 2 days.  by 1/19/22 the area looked bruised. area is 1 1/2 in x 1 1/2 in
Father stated symptoms began on 3/2/01. 9 hours, post vax, pt complained of headache and flu symptoms, crying episode with distinct body odor. Symptoms continued X 1 month.
Numbness and heaviness in left arm within 10 minutes after vaccine injection. Numbness also noted on left side of face and left side of lower back. All on same side as injection site. No treatment received and symptoms resolved within a few hours. Same symptoms also occurred after 2nd vaccine but seemed less extreme and for shorter period of time.
I had the booster in January of 2022. I woke up early in the morning with pain in my leg. I got in to see the doctor about it on Tuesday. He did a doppler ultrasound and confirmed there was a 8 inch blood clot in the femoral vain on my left leg. He prescribed Eliquis 10 mg per day. I spent 2 and a half weeks in bed trying to allow the blood clot to dissolve. I was given tramadol for pain. I returned to work part time as I was having some mobility issues. I started having additional issues where I started feeling really bad and I returned to the doctor and he determined that I was anemia which he believed was caused by a polyp. We cut back on the blood thinners and started some iron. About a week ago, I developed a pulmonary edema and drained about 4 liters of fluid from my lungs. This allowed me to breath easier. I had more test to ensure that the blood clot had moved to lungs and it had not. The provider suspected some cardiac issues were the cause of the symptoms. I am in the process of seeing a cardiologist today. I was hospitalized Monday after the endoscopy and colonoscopy because of breathing issues.
little pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little pain in left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Candida infection. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (little pain in left arm). On 08-Apr-2021, VACCINATION SITE PAIN (little pain in left arm) had resolved.            Treatment information was unknown.
Information has been received from a certified medical assistant concerning a 17 year old female who on 9/28/05 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot # 649274/0896P). On 10/11/05, the patient presented with a vesicular rash at the injection site that the CMA reported might have been shingles. The patient was treated with valacyclovir hydrochloride. Subsequently, the patient fully recovered. No product quality complaint was involved. The reporter considered the adverse event to be an other important medical event (OMIC). Additional information has been requested.