chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was very fatigued and incoherent the entire day.  She does have some short term memory loss normally but yesterday she was not able to track simple commands, she could not complete a sentence, she thought people who had dies years ago where living, she was unable to identify her daughter on the telephone etc.  None of these examples are typical for her it was very alarming and I was unable to find anything like this listed in side effects.  After a night of sleep last night she woke up "normal" this morning and she is not able to recall any of what happened yesterday.
patient came in for moderna bivalent but was given moderna pediatric monovalent due to similar labeling. no adverse reaction
Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indigestion (sour stomach). I was diagnosed with having Covid-19 on Nov. 9, 2020. I had a mild/moderate case which lasted over 2 weeks. After receiving my first dose of the vaccine in the morning, I started experiencing the same symptoms (in the evening) that I had when I had the actual virus. One week later, I'm feeling better.
Pt was given the pediatric dose instead of the adult dose, but was give 2 pediatric doses to equal the Adult dose that was needed.
Rash on trunk.  Rash on trunk subsiding and rasn on arms and buttock. Swelling of glands and lips noted.
Within seconds of receiving the shot father said patient collapsed onto table legs kicked and eyes rolled back. Lasted only a few seconds.
My whole face, jaw and the tip of my tongue became numb within 10 minutes of vaccination and this has lasted for 3 days so far. It is my 3rd day post vaccination and I was awoken at 5am this morning with stabbing pains in my right kidney that lasted for 3 hours. My left arm is still very sore and feels like I have a needle sticking in it every time I move it.
This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 18:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos disease and COVID-19. Concomitant medication was not reported. The patient was previously allergic to prochlorperazine (COMPAZINE). Prior to the vaccination, the patient was 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 COVID vaccine. On 09Apr2021 at 08:00, the patient experienced diarrhea, mouth ulceration along gum line, arm pain, shoulder pain and fatigue. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event diarrhea, mouth ulceration along gum line, arm pain, shoulder pain and fatigue were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients; Caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "Caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients".  Additional information: Caller was a pharmacist who wanted to report an administration error for Pfizer-BioNTech COVID-19 Vaccine (purple cap). Vaccines were stored in the refrigerator (temperature not known) for 42 days (not confirmed with caller). Upon checking the expiration information for this vaccine, caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients and caller wanted to know if those were valid doses. During the call, caller confirmed that the refrigerator containing the purple top Pfizer BioNtech vaccine has a temperature of 35 to 40 degree Fahrenheit and they have stored the vaccines 11 days past the expiration days (total of 42days). Previously they administered the affected supply to 2 patients and today it was administered to another 2 for a total of 4 patients. Patients were: 61 year old female / 53 year old Male / 61 year old Male / 64 year old Male.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200501508 Same reporter/drug/event, differnet patinents.;US-PFIZER INC-202200501509 Same reporter/drug/event, differnet patinents.;US-PFIZER INC-202200501510 Same reporter/drug/event, differnet patinents.
Patient received Covid Moderna bivalent vaccine yesterday at 12:37pm and called us this morning stating that the patient is having trouble breathing.
Pregnancy Miscarriage on 12/29/21, symptoms occurred 5 weeks after Covid injection.
Muscle pain, unable to lift arm above shoulder, fever, rash and swelling at injection site.
Information has been received from a registered nurse concerning a 26 year old female patient with sulfa allergy and no pertinent medical history who on 12-JUN-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 662300/0100Y), on 12-AUG-2009 was vaccinated with her second dose of GARDASIL (Lot # 661046/0381X), the nurse mentioned that the patient had not reactions after the first and second doses of GARDASIL. On 14-DEC-2009 the patient was vaccinated with her third dose of GARDASIL (Lot # 662304/1013Y). Concomitant therapy included hormonal contraceptives (unspecified). According to the nurse, on 15-DEC-2009 the patient experienced a reddened itchy area that was a couple inches below the injection site. The treatment for the patient was an antihistamine and cold compress. At the time of the report the patient was recovering. The patient sought medical attention by a phone call and a visit to the office. No diagnostic tests were performed. Additional information has been requested.
Large red mark over site the size of a large sand dollar, with mild itching- started 1/4-1/9/2021. One week after the vaccine
Moderna COVID-19 Vaccine EUA 2 days after receiving the vaccine I woke up with facial  tingling, numbness which extended around my ears. It comes and goes.
anxiety; twitching in lip; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety) and MUSCLE TWITCHING (twitching in lip) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (anxiety) and MUSCLE TWITCHING (twitching in lip). At the time of the report, ANXIETY (anxiety) and MUSCLE TWITCHING (twitching in lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a 29y/o ? Cauc, Merchant Marine who has a long, approximate 3-4 month history of recurrent ear infections, upper respiratory infections. He has experienced chest pain, progressive shortness of breath,  and fatigue. This had resolved prior to vaccination. He had a large infected area on his thumb. He has also experienced an approximate 10-pound weight loss over last 1 month or so. Client received his primary anthrax vaccination on 08/12/03 and primary smallpox vaccination on 08/12/03, while at sea off shore of Kuwait.  He did not want to have the vaccination done because he had been so ill. He was threatened by the MSC officer threatened the client with being thrown off the ship that day, would loose his right to work, and the MSC would press charges. It was 130 degrees F. on the ship that day. He felt so bad that he didn't feel like packing his stuff to leave the ship so he took the shots. He was not HIV tested prior to his vaccination.   After he received the vaccination, while on ship, he became very ill on day ~8. He states that he laid in his room without medical attention. He states he had a fever, which was high and felt dehydrated, "felt like eye   sockets were dry and had sand in them". He reports that on ~ day 8, his vaccination site "opened up like a huge crater" and was shaped like a figure eight. He began having shortness of breath, chest pain, fatigue, fevers, sweats, and chills approximately the 8th day after the vaccination. States chest pain was of the same type as he had experienced earlier, but much more severe (8-9/10).  He was allowed off ship approximately 4 weeks post vaccination (09/09/03). Flew home from Georgia to Texas and rested at home. He continued to experience daily fever (101?-103? F.), accompanied by chills, night/evening sweats, chest pain and shortness of breath. On the 15th of September, continued feel bad with same symptoms, so went to the his family doctor, who sent him to the cardiologist the next day. He had an echocardiogram and also had low blood pressure. He was admitted with impending tamponade.  He was subsequently diagnosed with pericarditis with pericardial effusion that required a subxiphoid pericardial window with drainage of ~200cc of fluid. The procedure also revealed significant adhesions that were broken up by finger dissection both inferiorly and anteriorly as far as the finger dissection could reach. There was also some "filmy" material that was sent for pathology. He had a pericardial window done on the 18th of September. The client reports that the cardio-thoracic surgeon stated that the fluid in the sac was like jelly and it had to be manually removed. He had a PPD placed which was reportedly negative. The pathology revealed fibrovascular tissue of the pericardium with fibrosis and marked chronic and mild acute inflammation. The pericardial fluid was negative for malignant cells, lymphocytes and rare neutrophils. The gram stains  for fungus was negative and AFB stain was negative for mycobacterium  for both specimens.
This spontaneous report was received from a physician referring to 12-month-old patient of unknown gender. The pertinent medical history or concurrent conditions were not reported. On 22-JUL-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
Received ROTATEQ on 6/3/08. Woke in night on 6/4/08 with vomiting times four. Early in week several loose stools. No fever.
Felt like she had Covid-19 all over again; Extreme body ache; Headache; Soreness in the arm at the injection site; Shivering/Chills; High fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Felt like she had Covid-19 all over again), PAIN (Extreme body ache), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness in the arm at the injection site) and CHILLS (Shivering/Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced COVID-19 (Felt like she had Covid-19 all over again), PAIN (Extreme body ache), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness in the arm at the injection site), CHILLS (Shivering/Chills) and PYREXIA (High fever). At the time of the report, COVID-19 (Felt like she had Covid-19 all over again), PAIN (Extreme body ache), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness in the arm at the injection site), CHILLS (Shivering/Chills) and PYREXIA (High fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. Treatment included Tylenol.
Bruising aprox 1 cm immediately surrounding site of injection, then swelling, tenderness, and pink induration approximately 5 cm in diameter.  Raised small wheals surrounding the 1 cm area of the bruise.  She obtained advice of a pharmacist and applied Benadryl which gave minimal relief.  By the time I could observe the site on 7/16/12, the redness, swelling and tenderness had diminished.
Patient had a sore arm after receiving the booster dose. It was administered too closely to the previous dose.
acute myocarditis 4 days after 2nd dose,chest pain; Fever on day 1; This is a literature report.  A 21-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "acute myocarditis 4 days after 2nd dose,chest pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever on day 1". The patient underwent the following laboratory tests and procedures: C-reactive protein: 4.6; Ejection fraction: 54 %, notes: inferior and posterolateral hypokinesia; Electrocardiogram: results below, notes: Diffuse ST-segment elevation; Magnetic resonance imaging: results below, notes: Edema, delayed enhancement, pericardial effusion, pericardial edema; SARS-CoV-2 test: negative; Troponin: 1.4; 1164. Therapeutic measures were taken as a result of myocarditis, pyrexia.  Clinical course: 2 days in intensive care; no inotropes or mechanical circulatory support; NSVT episode; discharged stable.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt. became weak & dizzy approx 2 mins after immunization; sweaty,clammy, & nauseated also.Pt rested for 1 hr & continued to experience dizziness & weakness.Sent home in father's care.
inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23; inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3524C, expiry date 31-MAR-2025) for prophylaxis.   On 19-OCT-2023, the patient received Arexvy. On 19-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered 0.5 mL of 2 vials of Arexvy Adjuvants mixed together instead of the Arexvy lyophilized component on 10/19/23). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The registered pharmacist reported a patient was inadvertently administered 0.5 mL of 2 vials of Arexvy adjuvants mixed together instead of the Arexvy lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter did not consent to follow-up from safety.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 30-JUN-2014 the patient received a 0.5 ml MMR II (lot # H012140, expiry date: 29-JUN-2014) (manufacturer unknown) subcutaneous which was expired. No symptoms reported. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Symptoms: Partial blindness in left eye and continuous Headache L BRANCH RETINAL ARTERY OCCLUSION Aspirin 81 mg PredniSONE 60 mg tablet
local pain(2 days), low fever (two nights), tiredness(2 days), hives in vaccine site (one week after)
parents reported sz like activity x 4 during period of 14NOV98-19NOV98;no fever noted following vax;no further reports of sx like activity since 19NOV;
Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching.  next morning had face and lip swelling and tingling.  self treated with antihistamines.  resolved after 3 days.
On 9 Mar 2017, (27 days post-vaccination receipt) patient presented to the Emergency Department (ED) with gait difficulty, right facial droop, and bilateral progressive leg numbness. He was admitted to Medical Center with the diagnosis of Guillain Barre Syndrome-Miller Fisher Variant. Patient received a 5-day course of IVIG with marked improvement. At discharge, on 16 Mar 2017, patient reported improved sensation in his feet and ankles. His neurologic exam demonstrated significant improvement of his ataxia. He was discharged to outpatient Physical Therapy. Patient returned to full duty and was able to complete Training.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 13:30 as dose 1, single (Lot number: EN6199), in left arm, on 25Mar2021 at 14:00 as dose 2, single (Lot number: ER8732), in left arm, on 30Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergy:Dairy" (unspecified if ongoing). Patient did not receive other medication in 2 weeks. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "recovered" (01Jun2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details: Product- COVID 19 Treatment, Treatment start date: 26May2022, Treatment stop date: 31May2022, Lot number: 00069-1085-30, Indication- Treatment of COVID-19.
The site below the injection site on the patient's arm became swelled, red, hot, painful, and itchy 2 days after vaccination. The affected area extended from the injection site on the backside of the patient's upper arm to the patient's elbow. Symptoms began to ease 4 days after injection.
Pt devel fever & diarrhea about 8PM was taken to ER for fever 105 R; MD treated w/APAP & Pedialyte; pt had fever x 3-4 days & diarrhea x 1.5 mos; Also had stomach virus;
Shortness of breath after 1st dose, increased shortness of breath after 2nd dose when talking and walking
Fever; Very sick; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and sickness. On an unknown date, the outcome of the fever and sickness were unknown.   It was unknown if the reporter considered the fever and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 1st dose of shingrix and was very sick and experienced fever.
Fore and middle finger knuckles swelled huge; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Feb2021 at 12:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included LOSARTIN and ATORVASTIN, both for an unknown indication from an unknown date and unknown if ongoing. On 19Feb2021 at 16:00, the patient experienced fore and middle finger knuckles swelled huge. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fore and middle finger knuckles swelled huge was resolving at the time of this report.    No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Client complained of tightness in her chest about 15 minutes after receiving the flumist vaccine.  Denied difficulty with breathing, just a sensation of tightness.  Vitals were taken and B/P was high (147/97)- other vitals were normal.  She began to feel "whoozie" and was sent to the ER for evaluation.