chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received her 1st COVID vaccine (Janssen) and presented for her booster dose. The medical assistant was handed a full dose (0.5ml) of Moderna instead of the booster dose (0.25ml) in error by the pharmacy technician in training. The medical assistant was unaware and administered the full dose; the patient didn't experience any adverse effects. Another pharmacy technician was reconciling the inventory and realized a full dose was missing and notified the medical assistant to try to figure out if the dose had been administered or not. After realizing the full dose had been administered the medical assistant and pharmacy technician notified their supervisors. The provider the next day and the patient coincidentally was also seen for a follow up appointment and was notified of the incident.
third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
This spontaneous report was received from a registered nurse regarding a 15 year old male patient with history of Lemierre disease and no drug reactions or allergies. The patient was vaccinated with M-M-R II (lot number and expiration date not reported) (dose and route were not reported) on 09-NOV-1998 and on 13-AUG-2002. No other suspect therapies were reported, there was no concomitant medication. On 21-JUN-2013 the patient was found to have a Mumps IgG of 0.59 (no reference units and ranges reported). The patient was required to have testing of titers for a camp physical. Outcome for Mumps IgG of 0.59 was unknown at the time of the report. No treatment was given for the above mentioned event. On 21-06-2013 an "m-MR varicell and Hepp B surface antibody" tests were performed (results not reported). It was reported that the patient sought medical attention (reported as "physical for camp"). The reporting nurse did not assess the relatedness between Mumps IgG of 0.59 and M-M-R II. Additional information has been requested.
Expired dose administered to 1 patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 1 patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No medical history were reported. .     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 1 patient). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 1 patient) had resolved.        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.   The reporter stated that a vial was opened by a pharmacy on 03-Aug-2021. It was supposed to be discarded end of the day but it was not. The vial was left in the refrigerator and dose was administered out of puncture vial on 04-Aug-2021. No concomitants medication were provided. No treatment medication were provided.
vaccine administered post excursion with no adverse event;   Initial information received on 13-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.    This case involves 11 patients who experienced vaccine administered post excursion with no adverse event while receiving vaccines diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].     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  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot C59638AA Expiration: 18Jan2024 and a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot C5779AA Expiration: 02Oct2022  unknown formulation and strength via unknown route in unknown administration site for prophylactic vaccination.  There was some Refrigerator malfunction and power outage Max/Low Temperature reached: First excursion: (negative) -0.6 C for 277 hours and 25 minutes Second excursion: 53.1 F for 18 hours and 52 minutes Duration out of labelled range: Total 296 hours and 17 minutes. No human Error was involved.  It was administered to 11 patients post excursion (poor quality product administered) (unknown onset and latency)   Action taken: Not applicable  Outcome: Unknown     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 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.
I reported to my doctor that around 2 weeks after receiving the J & J vaccine, a large bruise appeared on my right thigh. Their office recommended that I inform you of this.  Bruising is rare for me and I had not, to my knowledge, done anything to cause it. I have been in the system for follow-up reports regarding the vaccine and have always reported doing well. I have no other symptoms. This bruise, however, caught my attention after the latest news. So, I am reporting it, as directed.
Woke with chills and fever following morning, sore left arm, going to the bath more frequently,  tired and worn out for two days,  Then notice swelling of rt arm and large rash where I had received the jab.
Redness, swelling, painful at site of injection white border around site of injection LA back of arm.
Found unresponsive at the nursing home. When EMS arrived her sats were in the 60s on room air. She arrived to the emergency room on a nonrebreather.
2 X 2.5 INCH ERYTHEMATOUS AREA. EMPLOYEE DISCRIBES AS ICHY AND TENDER. DENIES FEVER, CHILLS OR PAIN.
Information has been received from a RN concerning a 4 yr old female with no known drug allergies who on 07Sep04 was vaccinated with a dose of varicella virus vaccine live. On 24Sep04 the pt developed a high fever and a rash. Her primary care physician treated her with antibiotics. No improvement was noted. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. The outcome was reported as not recovered/not resolved. The reporter also noted that a male child received varicella virus vaccine live and developed chickenpox (WAES0410USA00050). Additional information has been requested.
After patient received vaccination, she stated she felt a little dizzy. Patient became semi-conscious and was put in a wheelchair and placed on EMS cot. Ice pack applied to head; vitals taken. Patient became alert, awake, weak. EMS called; transported to Hospital. Patient reported she has been in heat all day with hadly anything to drink; patient has chronic dehydration.
Following the vaccine she noticed the same day fatigue.  She was so tired that she didn't understand it.  Then had headaches off and on, as well as muscle and joint pain everywhere, weakness all over her body.  She also had a low grade fever Saturday and Sunday.  She did have the  Corona Virus in July of 2020.  She is feeling better today as far as the weakness, just a little bit of muscle and joint pain.  She did have a trace of nausea this morning, but took her medication and it subsided.  The weakness was something like she had never had before.  She took Tylenol for her symptoms.  She did not call her doctor.   Just has a small amount of symptoms, but still not feeling herself yet.
After 14 hours, I woke with severe pain at the injection site. I was shaking and felt feverish but wasn't running a fever. I had a severe headache. My left thumb gave me problems. I couldn't bend it without it popping.  These symptoms have lasted since last night
Two days after the vaccine I was unable to walk. I could barely make it to the shower. I called my doctor but I decided to wait for the weekend because I was off work. I had joint pain in both extremities. My knees were the worst and my ankles, wrists, hands and knees. I could not write because of the pain and weakness. I have had MS 34 years but these symptoms were different. Normally if I have a flare up of my condition I have a lack of feeling but this was more like Arthritis. I have done a series of high dose Steroids which helped the symptoms but it seems to return 8-10 weeks after the course of Steroids ends. It has been six months and I am still experiencing symptoms. I have seen my MS doctor and my Primary Care Physician. I have been working but my job duties have been reduced to accommodate my condition.
lightheadedness; racing heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 10:30 (Lot number: ER8732) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prediabetes" (ongoing); "Thyroid problem" (ongoing); "High blood pressure" (ongoing). Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired (ongoing); LEVOTHYROXINE SODIUM taken for thyroid disorder, start date: 2015 (ongoing); LOSARTAN taken for hypertension, start date: 2015 (ongoing); LOTENSIN [TIMOLOL MALEATE] taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (dose 1, single, administered in arm right, Lot number: EN6199), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 IMMUNISATION, reaction(s): "Fatigue", "Arm sore where she got her first dose"; Flu vaccine (she had mild flu like symptoms but they went away the next day and she felt good), administration date: 2020, for immunisation, reaction(s): "mild flu like symptoms". The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021, outcome "not recovered", described as "lightheadedness"; PALPITATIONS (non-serious) with onset 25Mar2021, outcome "not recovered", described as "racing heart beat". Therapeutic measures were taken as a result of dizziness, palpitations.  Additional Information: The patient reported that she has been taking metformin for over 10 years and has been taking levothyroxine and losartan since probably 6 years ago. The patient mentioned that he didn't take her medications the day of the vaccine and didn't eat anything either for both doses. She hydrated very much before. Because of the events, the patient tried to relax and was laying down and it just comes on. It was not constant but it just comes on. It had worsened, that's why she made an appointment with her doctor. The patient took paracetamol (TYLENOL) the night of the vaccine and her daughter told her it made the vaccine less effective. The reporter was asking if it was true.  No follow-up attempts are possible. No further information is expected.
One day post vax, the pt began to have pain in all joints. The pt continues to have problems with right knee and left ankle. The pt cannot stand or walk for any length of time. There is pain and swelling most of the time in both.
No adverse event; The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.).    Concomitant medication was not reported.  Bivalent booster was administered on 6-Jan-2023.  Treatment medication was not reported.   This case was linked to MOD-2023-695514 (Patient Link).
Felt like someone was sitting on her chest, states had pain in hand, elbow and shoulder joints, started on 6/14/08 and then swollen neck and armpit, began on 7/6/08.  Pain still continues today.  Went to PMD on 8/13 - thought it was vaccine related - now doing massage and taking Ibuprofen.
Foggy brain for almost 48 hours. Couldn't think straight. Somewhat dizzy. Finally feeling better today, though I still get a little dizzy when I bend down or look down.
Patient is a 66 yo female that initially presented to the ED on 2/13/2022 with worsening shortness of breath, tested COVID positive on 2/4/2022. CTA revealed bilateral scattered groundglass type opacities throughout but no PE, pulmonary and ID were consulted. Patient was started on maximal therapy of COVID 19 with remdesivir, steroids, and metabolic therapy, and lovenox for DVT prophylaxis, admitted to regular COVID floor. Initially placed on NC and by 2/15 required NRB face mask, was started on baricitinib, and on 2/16 requried BIPAP with 100% FiO2.    US 2/17 positive for bilateral calf vein DVT and was switched to full dose lovenox, baracitinib stopped. Oxygen demand started to slightly improve to PRB on 2/21 and BIPAP at night. Remained on PRB face mask, CXR with progressive COVID PNA on 2/23. During night pt hypotensive, hgb dropped 2 grams, developed AF placed on cardizem gtt, transferred to COVID ICU, PRBC transfusion ordered, lovenox stopped, vascular surgery consulted for IVC filter, CT abd/pelvis revealed large left retroperitoneal hematoma. Patient continued to deteriorate, worsening hypotension requiring multiple pressors, A-lin placed, severe metabolic/lactic acidosis despite treatment lead to intubation. CTA abdomen pelvis did not show evidence of discrete vessel bleed, vascular surgery and IR reviewed case..    She developed acute severe renal failure, nephrology was consulted, dialysis and CVC line where placed and RRT initiated. Tolerated only less then 30 minutes due to hemodynamic instability. Continued blood loss despite multiple blood product transfusions, (for total of 7x PRBC, 4x FFP, 1 x Cryo). Given the patient's poor prognosis, her family decided to make patient DNR. Dialysis was attempted again but had to be shut down due to hemodynamic instability and tachycardia despite multiple pressors. Patient remained on MV and pressors and passed away on 2/26/2022 at 02:49 am.
After received second injection arm felt sore for a couple days; This is a spontaneous report from a contactable consumer (patient) or other non hcp via a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) on unspecified date for covid-19 immunisation. The reporter believed that the first dose was given correctly but not the second dose. After received second injection arm felt sore for a couple days on an unspecified date. Reporter was asking if there was a test he can receive (at name withheld) whether he had full protection from receiving both shots. Questionable concern about receiving the first shot. Stated there was a mix-up at the vaccination site, questions whether he actually received first dose due to faulty equipment. Asked vaccination provider, did not seem to provide an appropriate answer. Stated there was no indication that he received an injection. No indication of receiving an injection, no sensation, no indication received injection and no reaction. After received second injection arm felt sore for a couple days. Really doubts he received the first. Asking if there was a test to determine whether her had full protection. Stated he called the county where he resides, stated they have no control over. Reporter received both doses of the Pfizer Covid-19 Vaccine and wants to know if there was a blood test that he can take to confirm that he had the full benefit of the vaccine. The clinical outcome of event was unknown.  Information on the lot/batch number has been requested.  F/U #2 17Aug2021: Follow-up activities closed. Batch/lot number not available.
Swelling, redness, tenderness, warm to touch at injection area. After 3 days, no improvement, seemed to get worse. Pt stated small 'rash' on other part of arms and legs.  Those not visible on 6/18/2012 when pt returned to pharmacy.
The patient was administered adult dose of Hepatitis B vaccine. Pt did not experience any adverse signs or symptoms resulting from the administration
Pt came into pharmacy to notify us of her reaction. After ADACEL, her arm was extremely painful. She thought this was normal and waited about a week before consulting with md. The pain had not subsided and she was unable to sleep well or use her arm. Md stated immunization was not given in correct area of arm. Her arm would be fine and the pain would subside but it would take time. When pt came into pharmacy (1mos later), it was better but still painful.
Started feeling sick with flu like symptoms 12 hours after the shot. Over 4 days later I am still having gripping chills, major fatigue, dizziness, nausea, vomiting
Severe bleeding (passing lots of large clots with heaviest bleeding); Menstrual irregularity; Chills; Fatigue; Severe bleeding (passing lots of large clots with heaviest bleeding); This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself.  A 24-years-old female patient (pregnant at time of vaccination; unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 10Aug2021 at 16:00 pm (24-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing. The patient previously took skin lotions and experienced allergies. Concomitant medication included levetiracetam (KEPPRA [LEVETIRACETAM]) (patient received within 2 weeks of vaccination) for unknown indications from unknown dates and unknown if ongoing. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 10Aug2021 22:00, the patient experienced Menstrual irregularity and severe bleeding both after the first and 2nd dose (passing lots of large clots with heaviest bleeding than ever experienced in my life), chills and fatigue. No prolonged hospitalization for the events. No treatment received for the events. The outcome of the events were not recovered.
accidentally administered only the diluent portion of Menveo; accidentally administered only the diluent portion of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-MAY-2023, the patient received Menveo. On 17-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: accidentally administered only the diluent portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: accidentally administered only the diluent portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-MAY-2023 The reporter reported that a patient accidentally administered only the diluent portion of Menveo and wished to know how to proceed. They did not have information about vaccine or patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient accidentally administered only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Within minutes of injections (R) leg had multiple whelps while (L) leg had one at lower portion of left leg. Infant was extremely fussy but whelps resolved spontaneously with PRELONE administered.
Sometime in the early summer of '99 he began experiencing light-related eye pain and new onset headaches. He remembers headaches which were sharp pains behind the eyes 2-3x/week and severe migraines intermittently. He sought treatment at the clinic and was given Ibuprofen, which he took frequently without significant alleviation of symptoms. He reports he had to "push through the pain" regardless of his training and often tried to rest and use cold compresses on his forehead to alleviate the symptoms. He remembers with each anthrax vaccination he would have an exacerbation of the intensity and duration of headaches for a few days. He always linked his headaches to the anthrax vaccine because he never had significant headaches before, had sustained no head injuries and had no family history of migraines. Symptoms: Vascular headache, rash and oth nonspec skin eruption, generalized hyperhidrosis, unspecified abdominal pain, unsp symp and sign involve ner sysm.