chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14 year old male fluzone high-dose quadrivalent administered instead of Flucelvax Quadrivalent  with no reported adverse event; 14 year old male fluzone high-dose quadrivalent administered instead of Flucelvax Quadrivalent  with no reported adverse event; Initial information received on 01-Nov-2022 processed along with 2 live follow-ups regarding an unsolicited valid non-serious case received from a pharmacist. GMI case: 01347406   This case involves a 14-year-old male patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] administered instead of Flucelvax Quadrivalent  with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA455035 and 2022SA456571(same reporter).    On 31-Oct-2022, the 14-year-old male patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ93788, expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for immunization with no reported adverse event  instead of Flucelvax Quadrivalent  (Wrong product administered, Product administered to patient of inappropriate age) at same day latency.   It was reported that "Pharmacist is checking the safety of FLUZONE HIGH-DOSE QUADRIVALENT when administered to people younger than 65. She states that she is not yet sure if the HIGH-DOSE was administered to a younger patient but wants to have the information. Pharmacist states that last night, an elderly patient came in, and they prepared a FLUZONE HIGH-DOSE vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. Prepared syringe was placed back in the refrigerator. Two other patients came in later; a 45-year-old woman and a 14-year-old boy, who both received flu shots. Pharmacist then noticed that the FLUZONE HIGH-DOSE syringe was no longer in the refrigerator. She states that the intern was supposed to be giving Flucelvax Quadrivalent to the patients < 65, and at first the intern was sure that she had given that to both patients. But they can't find the HIGH-DOSE QUADRIVALENT, so the intern may have gotten the vaccines mixed up. She wanted to check the safety of the FLUZONE HIGH-DOSE QUADRIVALENT being given to younger people."  Action taken: Not applicable for both suspects.  At time of reporting, the outcome was Unknown for both events.     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.
On 10/7/00 a blood culture was positive for Streptococcus pneumonia. Septicemia is considered "medically important".
Patient began to faint after vaccine was administered. I monitored her and checked her blood pressure and called EMS. EMS cleared her to leave once she felt better. She was better in 45 minutes.
No adverse event; The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received a monovalent vaccine dose for his booster dose when he should have received a bivalent vaccine dose).    No concomitant medications were reported.  No treatment information was provided.
Patient describes having a local site reaction that swelled to about the size of a softball and feels hot to the touch.   Pharmacist following up with patient to see how she is doing.
Less then 2 minutes after injection I became very dizzy.  I felt a burning/tingling inside my body from head to toe.  It resolved within 15 minutes.  Less than an hour after injection I had severe chills and fever of 100.0.  Due to the dizziness and burning sensation my doctor recommend not to get a second dose of this vaccine.  I was sick for a few days after the dose and had the ?covid arm? rash/swelling/tenderness
COVID-19 breakthrough. I started with a cough. I was outside a lot so I thought it might be allergies. Monday I woke up and my chest and upper shoulders ached really bad. I had no fever. I was also very tired. Yesterday was a pretty good day, I was still tired and my nose was running. This morning I felt like I was going to pass out and weak. I also had a cold sweat. I've just been very tired overall. I went to urgent care because my doctor was taking too long to respond. I was prescribed a Z Pak, vitamin C, and zinc. They couldn't give me the medication that is supposed to help with COVID-19 because of the medications I am on and possible interactions.
awful "cold"; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who experienced the awful "cold (Nasopharyngitis), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient stated that every year the patient take the flu shot and soon afterwards come down with an awful "cold" (Nasopharyngitis).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown.  There will be no information available on the batch number for this case.
PATIENT WAS GIVEN MODERNA VACCINE 5/8/2021 AS SHE HAD STATED THAT SHE RECEIVED FIRST VACCINE AT OUR LOCATION ON 4/8 WHERE HAVE ONLY HAD MODERNA. SHE WAS THEN ADMINISTERED THE MODERNA VACCINE AND AFTER ADMINISTARTION WAS COMPLETE IT WAS DISCOVERED THAT HER FIRST DOSE WAS NOT AT OUR LOCATION AND SHE WAS GIVEN PFIZER BRAND FOR HER FIRST DOSE AT Facility ON 4/8/2021.
After administration of the flu vaccine, pt stated he was dizzy and passed out shortly thereafter. Pt became unconscious for ~2-3 seconds and then regained consciousness. While unconscious, pt's body jumped once. After regaining consciousness, pt was alert and was able to hold a normal conversation and drink water. I continue to monitor the pt for ~5 minutes. After ~5 minutes, pt passed out again. Pt became unconscious for ~5 seconds and then appear to regain consciousness for about a second until he passed out a third time for ~3 seconds. At this time, paramedics were called however when pt regained consciousness, he declined medical services and wished to call relatives (parents) to assist him. I continue to monitor the pt for 8-10 minutes. At this point, pt was sweating but stated he was feeling much better. Pt started to stand up and move around. I continue to monitor the pt until his parents arrived. I explained the situation with his parents and they helped him get home. There was no bodily harm when the pt lost consciousness. Pt looked fine when he left with his parents. I did inform him to seek medical inquiry.
weakness/ little weak; legs were shaky; legs suddenly gave out in the kitchen and she could not get up or pull herself up/ severe leg weakness; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 06Feb2021 at 16:30 as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 15Jan2021 for COVID-19 immunization and she was mostly in bed, sleeping for 2 days and felt extremely tired but was ok after resting. On 07Feb2021 at 14:00 the patient reported that her legs suddenly gave out in the kitchen and she could not get up or pull herself up and she had severe leg weakness. Because of her weakness, she stayed on the floor from 14:00 to 21:00. She asked a friend to come over and pull her up and she had to scoot to the backdoor to let her friend in. Her friend was unable to pull her up. About 15-20 minutes after her friend had arrived, her legs were still shaky, but she was able to pull herself up. she could not get up or sit up for 6 hrs and She did not lose consciousness, she tried to reach the fridge handle to pull herself up, could not do it from 2 pm to 9 pm. After that, she drank Gatorade (electrolyte) and ate food because she did not eat anything the whole time she was on the floor. She mentioned that she was weak for 2 days. After a couple of days, she was ok again. She reported that the AEs she experienced for the 2 doses were similar. However, she did not felt weakness since she was sleeping excessively. She said her AEs were so severe that she had to report it. She wanted to know if she could get the Pfizer vaccine if there may come a time that additional doses are needed to be covered for the new strains of the virus. She heard on the news about third shot of Pfizer's vaccine and was wondering if she could receive a third booster shot once it is studied. She also wanted to know if she could switch to another kind of COVID-19 vaccine (like Moderna) after completing the Pfizer COVID-19 vaccine vaccination series. Patient took Gatorade as a treatment for the events. The outcome of all events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
08/27/2022, after taking care of my husband and my daughter who had COVID-19, I woke up with a sore throat and fatigue. I had tested myself the day prior and was negative. However, when I tested myself that day I was positive. I got in right away for a PCR test and that was positive as well. I had severe body aches, severe fatigue, I couldn't get out of bed for a few days, decreased oxygen in the evening and a low temperature (100ish). I lost my sense of smell at about the 3rd day and then got it back by about the 7th day. It's mostly back now but still intermittent. My heart rate was very out of whack especially in the evening and it would correlate with the low oxygen. I continued to test positive until day 15. As the weeks went on, my oxygen and heart rate have slowly improved. However, right after the episode my HR would jump above 120 and take quite a few hours of rest to drop below 100. My endocrinologist did a blood test to make sure I did not have myocarditis and that came back negative. My PCP did an EKG this week and it came back normal. They ordered a Holter monitor and a chest x-ray to be done just to double check everything is okay. Lung output significantly decreased after having COVID but its slowly improving. Also, I have a very sticky mucus almost constantly stuck in my throat that seems to only be temporarily alleviated with hot fluids.
Within about 6 hours of being given the shots, my 2 yr. old son showed signs of being unusually unbalanced - his coordination and motor skills were affected, he was staggering, hitting furniture and "woozy" and he was not responsive at times staring off. He has also exhibited behavior changes with increased aggressiveness and irritability, interrupted sleep patterns at night waking often and crying during the last several nights.
EXPIRED HEPATITIS B VACCINE GIVEN TO PT PENTACEL DILUTANT GIVEN TO PT WITHOUT IMMUNE MIXED IN.
Chills; fever; Legs pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever) and PAIN IN EXTREMITY (Legs pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C021A and 051C021A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced CHILLS (Chills), PYREXIA (fever) and PAIN IN EXTREMITY (Legs pain). At the time of the report, CHILLS (Chills), PYREXIA (fever) and PAIN IN EXTREMITY (Legs pain) outcome was unknown.            No concomitant medications were reported. Treatment with Tylenol was provided by the patient to alleviate the symptoms experienced..   This case was linked to MOD-2021-257883 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.
New and continued rotator cuff pain (never previously experienced) since my second dose of Pfizer COVID vaccine.  Person who administered the shot struggled to remove the needle from my arm and it was very painful (the first dose, I didn?t feel anything).
No additional AE; HCP called to report mixing liquid PEDVAX HIB with the powdered component of ROTARIX/the products were reconstituted incorrectly; This spontaneous report was received from a licensed practical nurse referring to a 10-week-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 25-SEP-2023, the patient was inadvertently vaccinated with mixing the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # X003656, expiration date 06-NOV-2025, intramuscular in the left vastus lateralis; dose was not reported) with the powdered component of rotavirus vaccine live oral 1v(ROTARIX) (lot # 959LS, expiration date 17-FEB-2025, intramuscular in the left vastus lateralis; dose was not reported) for prophylaxis, the products were reconstituted in error (product preparation error). No adverse event was reported.
We received the following literature report on 15 JUN 2009:  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708, MA2009-1710 and MA2009-1712 to MA2009-1722).  Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
pt had OM @ time of vax & devel fever p/vax;that evening to MD a typical febrile sz;exam nl @ ER x/for OM noted previously;labs were nl;pt was discharged on Amoxicillin;
This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Right deltoid contusion 7cm x 6cm with .2cm abrasion in center, now 3 days later. no axillary lymph. Mom reports significant swelling the first 2 days but much better today.
The day after my second covid vaccination I had the expected body aches, neck stiffness, and joint pain. The following day, when I expected to feel better, I noticed I still had neck stiffness as well as joint pain in my fingers and wrists. I've also had fatigue since the vaccine. The neck stiffness has continued since the day after I received the vaccine. The joint pain in my hands has also continued and has spread to my elbows, shoulders, hips, knees, ankles, and toes. It is worse with increased physical activity and at night. Symptoms improve temporarily with naproxen and steroid injections. I have never previously had joint pain in my hands or neck stiffness for any other reason until March 21, 2021.
Patient's flu shot was  not given in the deltoid muscle, but above the muscle in her right arm. She is experiencing intense pain, bruising, and the inability to raise her arm. She is managing with ibuprofen, but still having pain in her right arm 12+ days after receiving the shot.
pt recvd vax; devel 12x12 cm area of swelling; MD prescribed ATB's & advised no more TYP vax;
*TIME OF WRITING IS THE 7th DAY* Onset of incredible fatigue 30 minutes post-vaccination lasting 5 days Fever ranging from 99.6 to 102 which began 5 hours after vaccination and has lasted 7 days post-vaccination Nausea 5 days post-vaccination Headache 7 days post-vaccination Severe arm pain 3 days post-vaccination Eye pain 3 days post-vaccination Intense sweating 7 days post-vaccination Chills 7 days post-vaccination Labored breathing 2nd and 3rd day post-vaccination Significant face swelling 2nd day post-vaccination Decreased mental status 6 days post-vaccination All lymph nodes in neck hard and swollen 7+ days Aggravation of pre-existing sleep paralysis day of vaccination Severe throat pain in the morning, red bumps in back of throat, white pus on tonsils which has worsened and began 1 day after vaccination (antibiotics were prescribed and condition continues to worsen, no one with whom I have been in close contact with has been sick - e.g. boyfriend I kissed the day before vaccine, toddlers I babysat morning before vaccine) - followed eventually by mild cough and congestion
Patient started having redness on her chest at 8:45 PM. Benadryl 25 mg given at 9:15 PM as redness on chest spread to rash across chest. BP 110/82 HR 88 at 9:15PM. 9:30 PM BP 120/90 and HR 112 and rash resolved. 9:45 PM BP 124/90 and HR 92. 9:55 PM patient sent home in stable condition with husband and educated when to go to ED.
she reports she just slept. Patient took 1st booster dose instead 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she reports she just slept.) and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (She is immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine NOS, ESTRADIOL for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose). On an unknown date, the patient experienced SOMNOLENCE (she reports she just slept.). At the time of the report, SOMNOLENCE (she reports she just slept.) had resolved and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) outcome was unknown.            No treatment medications were reported   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550751 (Patient Link).
received second dose at day 15; A spontaneous report was received from a pharmacist concerning a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received 2nd dose at day 15.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026L20A, Exp. date: 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist reported that the patient received their 2nd dose 15 days after the 1st dose instead of on day 28 which was the recommended return vaccination date. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, received 2nd dose at day 15 was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (Lot number: 026L20A). There were no reported AEs associated with this case of Inappropriate schedule of product administration.
Patient was Administered  a vaccine that was Expired. No syptoms present or developed at  the time vaccine was given