chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP is calling for an excursion that happen on 22May2022 in the freezer.; No adverse event; HCP is calling for an excursion that happen on 22May2022 in the freezer.; Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.), POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.), WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     HCP stated she was unaware if any patient had any medical history or condition.     In June 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) .5 milliliter. In June 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.), POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.), WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling for an excursion that happen on 22May2022 in the freezer.), POOR QUALITY PRODUCT ADMINISTERED (HCP is calling for an excursion that happen on 22May2022 in the freezer.) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT as first dose).    Concomitant product use was not provided by the reporter.  The vials did not have a previous excursion. The maximum temperature reach was 12.84 Fahrenheit. The 1st lot number was AS7642B, which was administered to 6 patients in June. The 2nd lot number was 201L22A and had not been administered. The patients were 4 female and 2 male.  Treatment information was not provided.  This case contains information about patient 6th out of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732263 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732263:same report, master case patient female patient
Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake.  I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy.  The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization, reaction(s): "I had some of the side effects after the second shot that lasted 1-2 days". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information included: Patient was 65+ category and was reading about the possibility of a fourth covid shot. Patient had some of the side effects after the second shot that lasted 1-2 days. When patient got the booster shot, patient had almost all of the side effects and was sick for over a week. Her husband was so concerned he almost took her to the hospital. She would be interested in the fourth shot, but what was the chance the side effects would be worse than those she experienced with the third shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On Oct 3rd, I gave a couple FLUAD and PNEUMOVAX on the same arm. The Lady's arm got swollen all the way to her elbow the next day. I have not seen her but she said she had to go to the doctor. She complained of body ache and pain after receiving the vaccines. The next day after work she went to see a doctor. They told her it was infected. They gave her a shot at the clinic and send her home with BACTRIM DS BID for 10 days. She reported the swollen to have reduced but it is still red. I also advise her to use some over the counter Ibuprofen and Hydrocortisone cream from over the counter. I will also continue to check on her to make sure she is improving. I am not sure which vaccination led to this reaction. PNEUMOVAX was given at one centimeter below the FLUAD shot.
Narrative: Full history is not known to this reporter. Per nursing note and discussion with nurse the patient was hospitalized several weeks after initial Shingrix (herpes zoster) vaccination for an unknown period of time. He was treated with steroid therapy and advised to not take second dose of the series.
Receiving the second dose due to heavy bleeding; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of unspecified age received the second dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Lot Number and Expiry Date were not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took historical vaccine dose 1 of BNT162B2 on an unknown date for Covid-19 immunisation. It was reported that on an unknown date patient experienced heavy bleeding or extended periods. Patient was hospitalized after receiving the second dose due to heavy bleeding. Reporter asked that was there any data or studies relating to this issue. The outcome of the event was unknown.   Information on lot/batch number has been requested.
PATIENT COMPLAINED OF PAIN AND SWELLING THE NIGHT OF THE VACCINE. THE NEXT DAY FOLLOWING VACCINE HIS ARM WAS RED FROM THE SITE DOWN TO HIS ELBOW.  DR PUT HIM ON ANTIBIOTICS.
Received pneumococcal & Tdap vaccine on 9/30/11. Since then, hot & cold, body aches, arm pain with increased redness, swelling & pain. Elevated WBC, fever, increased thirst. Sent from facility to ED and then hospitalized x4 days.
The next morning, I woke up with sore arm - not quite as sore as before (first vaccine). I was hydrating all the time - more than usual. I was foggy. That weekend, I started having hot flashes. Not a measurable fever - hot and red face. I didn't have them the week before and I hadn't had them for months before. My family, who had gotten vaccinated the same day - were getting fevers and I had hot flashes. They were legit! I had no energy. I had to lay low and not do nothing for those two days. I did go to work the next week - but I wasn't thinking my best. My energy was low and I was foggy.
Information has been received from a nurse (L.P.N.) concerning unspecified patients who on an unspecified date were vaccinated with improperly stored RECOMBIVAX HB. The patients were not experiencing any known symptoms. This is one of several reports received from the same source. MARRS number 1206USA04796. All telephone attempts to obtain follow-up information have been unsuccessful. A message was left with the receptionist requesting return the call. Additional information has been requested.
I was dizzy, lightheaded, and sweaty. I felt like I was about to pass out. The doctor gave me a cold pack, had me to lay down and checked my vitals--all were normal. I sat there for about 20 minutes until I was feeling better. I still have some soreness and lingering headaches.
After receiving the flu vaccine, I've been experiencing intermittent burning tongue and tingling sensations on my tongue/ top of mouth.  I experienced this sensation 2 days prior to testing positive for COVID19 on 12/16/22.  The intermittent burning tongue/ tingling occurred off and on for several months after I tested negative for COVID19 but resolved.   The burning tongue/ tingling returned after receiving the flu vaccine.  The burning tongue/ tingling sensation is disrupting my sleep and causing discomfort to my tongue/ roof of mouth.  The sensation causes me to have intermittent coughing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (bivalent), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: after negative tests for 3 days during the paxlovid course; (04Jan2023) Positive, notes: 2 days later tested positive again. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Child was given a VARIVAX and MENACTRA on L arm. Medical assistant left the room and within sec mom called for help when the physician returned child was slumped over and unresponsive. He was place on bed on exam table feet raised and after about 30 sec. became responsive to verbal commands. No tonic clonic movement. After P 60 and BP 110/60. After after 15 min was sitting up P 50 BP 118/66 after a few more min able to speak no faint. C/O feeling dizzy but for the next day.
patient received an expired dose of boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 24-JUL-2023, the patient received Boostrix (left deltoid). On 24-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 24-JUL-2023 A pharmacist reported that a patient received an expired dose of boostrix which led to expired vaccine used.  The reporter consented to follow up.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 68-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 05-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Patient had received 2nd booster 10/22/21 and received 3rd booster a month earlier on 2/23/22. No adverse events noted
PATIENT REPORTS STARTING SATURDAY 10/8/22 HE HAD RASH ON HEAD/FACE/TRUNK. HE HAD LEG PAIN, BACK/BODY PAIN AS WELL. RED, RAISED LESIONS STILL VISIBLE 10/10/22 AND PATIENT STATES HE STILL FEELS UNWELL. PATIENT ADVISED TO SEEK MEDICAL EXAMINATION.
Pt received Flu vaccine in clinic 15 minutes after experiencing flushing of right side of chest and face that progressed to both sides. Heart rate increased to 171, temp increased 37.6.
hives/welts; top lip gets fat and he gets a metallic taste in his mouth when he feels the hives coming out; hives are very itchy and welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/welts), DYSGEUSIA (top lip gets fat and he gets a metallic taste in his mouth when he feels the hives coming out) and PRURITUS (hives are very itchy and welts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives/welts), DYSGEUSIA (top lip gets fat and he gets a metallic taste in his mouth when he feels the hives coming out) and PRURITUS (hives are very itchy and welts). The patient was treated with CORTISONE at a dose of 2 shots; PREDNISONE at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives/welts), DYSGEUSIA (top lip gets fat and he gets a metallic taste in his mouth when he feels the hives coming out) and PRURITUS (hives are very itchy and welts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient recived a premature second dose of Peneumovax; This spontaneous report has been received from a pharmacist referring to a 55 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. 3 years and 8 months later, the patient received an additional dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (inappropriate schedule of product administration). The causality assessment was not provided.
I had a sore arm for a couple of days.  Thursday I woke up early with my nose filled with loose congestion.  I had chills and was exhausted all day, I took a couple of naps, but registered 95 degrees on the thermometer, so no fever.  The next morning I felt weak and nauseated, but I was fine by 10 a.m.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that these unspecified patients may had received improperly stored M-M-R II (lot #, dose, route not reported) and sterile diluent on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Jan. 8 - sharp pain in the left side of neck itching at the injection site and down the left side of the body near the left breast, left side of belly and hip, thigh, and knee, and at the left crease of the knee.  Very tired.   Jan. 9 - Left shoulder pain and the left side of neck, very tired.  Jan. 10 - sore shoulder and neck left side only.  Very tired and sleepy, slept 22 hours, every time I awoke I was still very sleepy and fell immediately back to sleep  Jan. 11, - Excessive sleep and feeling dehydrated.
swelling (knot), pain, stiffness, and inflammation at the injection site, fever, chills, body aches, headache, loss of appetite for 3 days and ongoing at present
Noticed mosquito-bite looking whelps which got worse overnight. Took her to the ER 11/29/09 at 7:30 PM. Treated with Benadryl, Tylenol, Epinephrine, steroid injection. On 11/30/09 Mom states whelps are still present, some areas are worse. Rash on all parts of body except head and face.
I  went to get my MMR and Varicella vaccine booster at our Employee Health Clinic, during this time I was accidentally give a second dose of COVID-19 booster despite  already receiving a booster shot 7 days previously. I also received my MMR booster and Varicella vaccine at this time, however my Varicella was expired 10/07/2021. At this time I am unsure of the adverse events caused by this incident.
Large approx. 4-inch red, warm, raised welt. Itchy with no systemic symptoms. Localized at this time.
Patient stated she started to feel dizzy and nauseated. I gave her a bottle of soda. As I was about to check her blood pressure, she seemed to lose consciousness. Her eyes rolled back in her head, and she seemed to be out of it for a few seconds. She came back to about 10 seconds later. She was pale, sweating, and had urinated on herself. I gave her a cold rag to wipe her face off. We called 911. Kept reminding the patient to take slow, deep breaths. Ambulance came and checked patient out, but she refused to be transported to hospital. I called to check on the patient later that night. She stated she had taken a nap when she got home, but was overall feeling better
AFTER INJECTION, THE VACCINE SOLUTION LEAKED OUT OF THE INJECTION SITE.  PT HAS REQUESTED THAT WE RE-ADMINISTER HER 0.25ML BOOSTER MODERNA VACCINATION.  WE CURRENTLY PLAN TO RE-ADMINISTER THIS DOSE ASAP (PT STATED SHE WOULD COME BACK ON FRIDAY 11/12/2021 IN THE MORNING).
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started during Nov-2014. It was reported that the patient had administered FLUMIST under the age of 2 years. The outcome of the event of PATIENT UNDER THE AGE OF 2 YEARS RECEIVED FLUMIST was unknown. The report was considered to be non-serious.
Paresthesias of lateral tongue and throat, subjective swelling of tongue and throat, subjective shortness of breath
10 PM - felt very tired, hands and feet (all the way into wrist/ankle area) extremely cold and very pale in color), temp 99.8  7:30 AM - woke to get sip of water, felt very light headed, after water on way back to bed went into bathroom, came out and said I feel like I am going to throw up and with that he fainted or seized with noises and eyes back, skin color changed and we called 911.  He revived before 911 arrived and was trembling and weak, also he now vomited up yellow liquid.
Injected the Moderna Vaccine into the joint space of proximal head of right humerus/posterior; Exquisitely painful/ pain radiating from injection site to right hand; Fever; Soreness/ Local aching pain at site; A spontaneous report was received from a nurse who was also a 72-year-old patient, who received Moderna's COVID-19 Vaccine and who experienced soreness at the injection site (vaccination site pain), injection into the joint space of proximal head of right humerus/ posterior (incorrect route of product administration), fever (pyrexia), and radiating pain into right arm and hand (pain in extremity).   The patient's medical history included asthma. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: not provided) on an unspecified date.   On 05 Feb 2021 at 3:30 PM, the patient received their second dose of mRNA-1273 for the prophylaxis of COVID-19 infection into the joint space of proximal head of her right humerus/ posterior, which was exquisitely painful and felt like vaccine hit or was going into a ligament or tendon. She experienced radiating pain into right arm and hand. She also experienced a fever of 100.4 degrees Fahrenheit.  On 07 Feb 2021, the patient's fever resolved.  On 08 Feb 2021, the pain radiating from injection site to the patient's right hand resolved.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, soreness at the injection site, was resolved on an undisclosed date.  The outcome of the event, injection into the joint space of proximal head of right humerus/ posterior, was resolved on 05 Feb 2021. The outcome of the event, fever, resolved on 07 Feb 2021.  The outcome of the event, radiating pain into right arm and hand, was considered resolved on 08 Feb 2021.; Reporter's Comments: This report refers to a case of product administration error with associated expected events of pyrexia, pain at vaccination site and pain in extremity.
Information has been received from a consumer concerning her 16 year old daughter with lactose intolerance and not other drug reactions or allergies who was vaccinated with the first two doses of GARDASIL "sometime in 2007". After both doses she did not feel well. On approximately 22-APR-2009, "three weeks ago", the patient was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On the night of 09-MAY-2009 the patient started to have a headache and stomach aches. In the past three days her stomach issues and headache have gotten worse, that she came home crying on 12-MAY-2009 because of the pain. As of 13-MAY-2009, "today", the patient was still experienced these symptoms and now she also felt hot to touch but did not have a fever. It was also reported that the patient just got her menstrual cycle and was going on three days of having that . No lab tests were done. The physician was called and unspecified medical attention was sought. The reporter was not sure the experiences the patient was having was from GARDASIL. Additional information has been requested.Records received 7/2/09-on 5/9/09 C/O headache, feeling feverish, stomach ache, tiredness, office note for 5/22/09-seen for C/O sinusitis no further visits.
Irregular heartbeat beginning around 7:45 PM 02/16/2022 First sign of Atrial Fibrillation at 9:40 PM 02/16/2022 Continued irregular heart beat and either inconclusive ECG and intermittent Atrial Fibrillation continued until 8:00 am 02/18/2022  Irregular heartbeat returned with inconclusive ECG at 10:00 PM 02/18/2022 and continued until 8:45 PM 02/19/2022  Diarrhea began at 07:15 am 08/17/2022 and continued until 8:30 am 02/19/2022
About 5 minutes after the vaccination, child had a tonic-clonic seizure lasting 1.5-2 minutes.