chrisvoncsefalvay/vaers-outcomes huggingface dataset:
came in for a shot of FLUZONE HD, and after the shot had been administered it was found the patient had already received a dose in October of the year/ no AE; Initial information received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional via call center via Agency (Reference number- 00893833).  This case involves an unknown age and gender patient who was vaccinated with an extra dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Extra dose administered).  The patient's past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  It was reported "Caller states a patient came in for a shot of FLUZONE HD, and after the shot had been administered it was found the patient had already received a dose in October of the year. Caller would like to know are there any adverse effects that may occur with an extra dose?."  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.
Diagnosed with intussusception 8 days after 4 month vaccines.  Neede surgery and was discharged 2 days later,  3/16/09 Received hospital medical records for 3/10-3/11/2009 & 3/12-3/15/2009. FINAL DX: Enterocololitis, probable intussusception, exp laparotomy, appendectomy, right inguinal hernia repair Records reveal patient experienced irritability, diarrhea x approx 7-10 days, intermittent abdominal cramping & nonbloody stool x1on 3/10.  Multiple attempts to reduce w/BE unsuccessful.  Taken to OR where no obvious IS seen.  Progressed well post op & d/c to home.  Developed recurrent bouts of abdominal pain & cough at home.  Taken back to OR for diagnostic laparoscopy where no IS seen but colon dilated, prominent adenopathy & thickened ascending colon.  Referred to GI.
Patient received Pfizer vaccination in Administration clinic. While in post vaccination observation, patient complained of feeling warm, lightheaded. At that time, patient reported she failed to inform nurse of current penicillin allergy. Proceed out called. Took vital signs at 15:05, 130/83, HR 83, 02 sat 99%. Repeat vital signs 15:24 BP 125/83, HR 83, 02 sat 97%. Patient transferred to ED for further monitoring.   In the ED, patient was monitored for few hours where the light headiness has subsided. patient was discharged home.
He got PREVNAR and flu shot from us on 1/14 (the same day, he got shingles from different pharmacy). He came today (1/22) and told me that he got sick (cold and flu-he sounded very congested) 2 days after. He said he got better over the week and he just wanted me to know. I explained to him that those are dead viruses and it could be just coincidence.
Cold chills, intense arm pain, heavy sweats, nausea, joint/bone pain, headaches, fatigue
Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Lot number: ER873U) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Tired".  Additional Information: Patient had her last COVID Pfizer shot on 31Apr and she is very tired. She was asking if it was normal to be so tired. Start date of event was reported as about a week after.   No follow-up attempts are possible. No further information is expected.
Itching on neck; Hives devel neck & on scalp & chest; just generally didn't feel well;
Ringing in ears, like crickets; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and TINNITUS (Ringing in ears, like crickets) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). On an unknown date, the patient experienced TINNITUS (Ringing in ears, like crickets). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) had resolved and TINNITUS (Ringing in ears, like crickets) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that no concomitant medications were taken. No treatment information provided.   This case was linked to MOD-2021-097873 (Patient Link).
Experienced chills and slight fever (100.8).  Treated with Tylenol.  Adverse Event resolved the next day.
Fatigue; Soreness at injection site; Diarrhea; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 (at the age of 34-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history was not reported. The patient didn't have any known allergies. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced fatigue, soreness at injection site, diarrhea and headache. The patient didn't receive any treatment for the events. The clinical outcome of the events fatigue, soreness at injection site, diarrhea and headache was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of event data as Treatment Received updated to No and narrative updated; known allergies: No captured in narrative.
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes are itchy), FEELING HOT (rashes are hot to touch), VACCINATION SITE RASH (red rashes around the injection site of right arm) and VACCINATION SITE ERYTHEMA (red rashes around the injection site of right arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 025A21A) for COVID-19 vaccination. No medical history reported. Concomitant products included GABAPENTIN, FUROSEMIDE, Cyclobenzamine, POTASSIUM, ATORVASTATIN CALCIUM (CRYSTORVAS), ZOLPIDEM TARTRATE (AMBIEN), DULOXETINE, HCTZ, METFORMIN and CARVEDILOL for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced RASH PRURITIC (Rashes are itchy), FEELING HOT (rashes are hot to touch), VACCINATION SITE RASH (red rashes around the injection site of right arm) and VACCINATION SITE ERYTHEMA (red rashes around the injection site of right arm). At the time of the report, RASH PRURITIC (Rashes are itchy), FEELING HOT (rashes are hot to touch), VACCINATION SITE RASH (red rashes around the injection site of right arm) and VACCINATION SITE ERYTHEMA (red rashes around the injection site of right arm) outcome was unknown.
Sweating, C/O feeling hot and lightheaded, denies CP, denies difficulty breathing, drowsy/loopy but conscious. Hx of syncope/autonomic nerve/jitters pt with blood draws or receipt of injections. Event lasted 6 minutes. Pt monitored by nurse x 15 minutes and BP obtained and WNL. Reviewed S/S adverse reaction with pt.
Around 08/01/2022, I had a severe rash on my right forearm. I do have a lot of environmental allergies, so I didn't think much of it. A few weeks later, I came down with shingles. I have no idea if they are related to my COVID-19 vaccine. I believe I had shingles in late September or early October. I went to see my doctor who prescribed an antiviral medication. It probably took about five days for the rash to go down after that. The rash itself was never painful but it was all over the left side of my body from my breast to my hip, front and back.
101 temperature,  vomiting, chills, body aches and headache.  for 3 days
Redness in arm; Swelling in arm; Hot; Hard; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), FEELING HOT (Hot) and INDURATION (Hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), FEELING HOT (Hot) and INDURATION (Hard). The patient was treated with CLINDAMYCIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), FEELING HOT (Hot) and INDURATION (Hard) 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 medication was not reported.   This case was linked to MOD-2021-128176, MOD-2021-128305, MOD-2021-128649, MOD-2021-128612, MOD-2021-128689, MOD-2021-128643 (Patient Link).
No additional adverse events; Product storage error; This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 28-JAN-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) with lot # 1621926 and expiration date reported as 28-NOV-2021 for prophylaxis (strength, dose, frequency, route were not reported) (product storage error). No adverse events were reported. The physician reported that the physician received only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9). The outcome of product storage error and no adverse event was unknown.     This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2002USA001552:
3 inch by 3 inch indurated area with nodularity under the injection site approximately 3 cm by 3 cm. Very TTP, with Rubor
Immediately after receiving vaccine in right arm, patient felt nauseated and ill. The next day she reported a rash wrapping around the right arm with swelling, had sharp pain, and cannot lift right arm per mother's report. Her left arm had burning in the fingers and was sore. She had a fever of 102 for two days. Mother called on 11/16/2018 to report incident and that she was taking her daughter to the ER that night. A student nurse administered the vaccines. Called mother on 11/19/2018 to see if she took her daughter to the ER and the outcome. Left mother a message.
Initial report received from a health care professional (physician) on 24 Feb 2011: This patient was vaccinated with FLUVIRIN (batch number: 70619) 0.5 ml on an unspecified date in Nov 2006.  Twelve hours post vaccination, the patient developed myalgias, joint pain and weakness.  The patient visited multiple physicians with multiple diagnosis including polymyositis and arthralgia (probably no biopsy was ever done as per the reporter).  The patient exhibited difficulty ambulating.  On an unknown date, the patient had elevated inflammatory markers (C-reactive protein, ESR of 48 and RF of 91).  The thyroid stimulating hormone, transaminases were negative and there was no CCP (cyclic citrullinated).  The outcome of the events was not reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2015, she was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXIA
Erythema multiforme devel w/in 48 hrs of vax then pt cont w/diarrhea & vomiting until 6MAR92;
Covid19 breakthrough.  1st Vaccine received on 04/23/2021.  47 y/o with PMHx of asthma presents to ER with 4 days of abdominal pain and mainly confusion.  Husband states pt having hallucinations and saying things that don't make sense.  Rm air 96%,  CXR unremarkable.  Started on IV Abx for UTI.
Worsening of vertigo; Body exacerbated; High temperature; Arms and legs fatigue immediately; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Worsening of vertigo), CONDITION AGGRAVATED (Body exacerbated), PYREXIA (High temperature) and FATIGUE (Arms and legs fatigue immediately) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Multiple sclerosis relapse (Relapsing remitting multiple sclerosis), Vertigo, Vitamin D low, Migraine, Inflammatory bowel disease (IBS), Trouble falling asleep (Trouble sleeping), Depression, Anxiety, Polycystic ovarian syndrome, B12 deficiency anemia, Insulin resistance (Insulin resistance associated with PCOS), Drug allergy (Vicodin), Drug allergy (Percocet), Drug allergy (Dilaudid), Latex allergy, Drug allergy (Wellbutrin allergy), Drug allergy (Celexa allergy), Drug allergy (Tecfidera allergy), Drug allergy and Pain. Concomitant products included OCRELIZUMAB (OCREVUS), CLONAZEPAM, VITAMIN D2, TOPIRAMATE, GABAPENTIN, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL), DICYCLOMINE [DICYCLOVERINE], TRAZODONE, PAROXETINE, NORETHISTERONE (DEBLITANE), CYANOCOBALAMIN, METFORMIN, LORAZEPAM, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 21-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Worsening of vertigo), CONDITION AGGRAVATED (Body exacerbated), PYREXIA (High temperature) and FATIGUE (Arms and legs fatigue immediately). At the time of the report, VERTIGO (Worsening of vertigo), CONDITION AGGRAVATED (Body exacerbated), PYREXIA (High temperature) and FATIGUE (Arms and legs fatigue immediately) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant medications also included steroids.
Patient was dizzy post vaccine. He hadn't taken his antihypertensive medications. He required extra recovery time and the dizziness subsided
Information has been received from a receptionist concerning her daughter who on an unknown date was vaccinated with a dose of GARDASIL (lot no. and route not reported). The receptionist reported the patient experienced HPV after receiving the vaccine. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a Medical Assistant refers to 9 weeks old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
My first 3 doses of the COVID19 vaccine were Moderna. This is my first Pfizer vaccine. Right after receiving the vaccine, my arm hurt like the other vaccines. However, the pain worsened as the day went on to the point where I had to use an ice pack on the injection site and take 1000mg of Tylenol every 6 hours. I continued with this pain for the next day. Each day afterwards the pain got gradually better. I was taking the Tylenol for a total of 5 days. I was unable to lay on the left side for 2 nights and it hurt to use it as well. Once the pain stopped, I have been getting intermittent dull achy phantom pain at the injection site about 3-4x weekly and each episode lasts pretty much the entire day.  With the first 3 doses (all Moderna), I got chills, body aches and felt like I had the flu. I am sensitive to medicines. With the J&J vaccine, I did feel a little sick but it went away quickly.
2 patients inadvertently received DAPTACEL instead of ADACEL with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (Reference number- 00736452).  This case is linked with the 2021SA282217 (same reporter).  This case involves a 12-year-old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 31-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot U6900A, expiry date-18-Nove-2022) via an intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered (latency same day).  It was reported, "2 patients inadvertently received DAPTACEL instead of ADACEL. Caller with question on whether a dose of ADACEL now needs to be administered. Caller also with question on when the patients will be due for a booster dose of ADACEL".  At the time of reporting, no adverse event reported.  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. 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.
Shortly after adminsteration, patient was walking over to the waiting area and got dizzy and fell to the ground. Was sweating profusely. Called the paramedics. Heart rate, blood pressure, and EKG was normal upon their arrival (with in 5-7 minutes from administration)
This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A through A0809359A, A0809361A and A0809362A.
Pain at injection site (left arm above the deltoid in the shoulder joint area), dimished function of left arm. Nurse gave vaccine while standing with patient in the sitting position. Felt as though needle hit cartilage or bone in the shoulder region. I've had pain in the shoulder joint for over two-weeks now, but seems to be subsiding. It is not waking me during the night as much and I do not have the sharp pains from lateral movement and weight bearing activities. Still tender with a small marble/kernel area at the injection site. No treatments seeked yet, but pain does still persist.
I had a flu vaccine shot at the same time. I did not save the information. Local pharmacy administered both. 4 days after shots I had the ususla aches, pains chills, on 5th day I had diahrea, which worsened over the next two days. I am very weak beacuse of this and took Imodium and ate bland diet to return to normal. The only other time I had a bad reaction was after my 2nd primary shot when I had extreem joint pain one week after receiving the shot. 3 days of diahrea is very bad for most seniors. One week after getting the shots I am still trying to recover my strength.