chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of headache in a 53-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced headache, chills, pharynx strange sensation of and fever. On an unknown date, the outcome of the headache, chills, pharynx strange sensation of and fever were unknown. It was unknown if the reporter considered the headache, chills, pharynx strange sensation of and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter had a consumer that received the second dose of the SHINGRIX one day earlier than the schedule. The patient was experiencing funny feeling in her throat. The reporter did not want to continue to answer questions and wanted to be transferred to MI.  Unable to obtain additional information as he said he can provide additional information when GlaxoSmithKline contacts him via letter.
TONGUE TURNED WHITE ANE SWELLED UP.  RED RASH AND HIVES ON FACE CHEST, ARMS & STINGING ON MY TONGUE.  WITHIN 1 HOUR OF INJECTION HAD SYMTOMS AND TOOK BENADRYL  WHEN THAT WORE OFF WAS MUCH WORSE AND REQUIRED GOING TO EMERGENCY DOCTOR CENTER
Headache; Chills; Nausea; Fatigue; Tender; Heat sensation in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat sensation in arm), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (severe allergy with Tylenol with codeine).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat sensation in arm), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Tender). On 06-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Heat sensation in arm), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-062524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062524:case for dose 2
Pt. called on 9-17-08 complaining of pain at injection site since given 09-03-08. 9/18/08 pt seen in office-treated by NP. 9/22/08 PC to pt, feeling better, decreased redness and edema, better ROM. NP
Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Also experienced severe pain at the injection site, that worsened over the evening. All symptoms continued through the evening. Also experienced night sweats. The following morning, headache and mild chills were present, but other symptoms had abated. Had minor brain fog. Those symptoms resolved over the course of the day. All symptoms, except night sweats, have cleared up. Night sweats are ongoing.
muscle pain and aches; muscle pain and aches; Initial information was received on 31-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via specialty pharmacy .  This case is linked to case 2022SA453284(CLUSTER).  This case involves a 14 years old male patient who experienced muscle pain and aches after being vaccinated with Influenza vaccine.  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 Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, form, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient had muscle pain and aches (myalgia) (pain)(unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Developed circular erythamatous 2" rash around site of injection approximately 5 minutes after vaccine. Reported feeling dizzy. Given Benadryl 25 mg po and juice. Felt better. No further dizziness.
On 1/2/01, one vesicle on the inner ankle was noted. The child complained of being cold and feeling tired. By the next morning the child had red, "pimply spots" on body. Had a fever for 2 days reaching 104.7. Child was covered with vesicles. Mother noted they didn't seem to itch as much as you might expect. All vesicles healed after 1 week. Treated for ear infection. Treated with Amoxicillin.
Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 012M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle). On 17-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Health care professional (HCP) nurse got two doses of moderna covid 19 vaccine 1st and 2nd dose in left upper arm deltoid muscle. On 17-Sep-2021, nurse got the booster which was her third dose, however, it was administered subcutaneously not intramuscular, in her left arm below the deltoid muscle. She stated that she read that the efficacy was different, because she got her booster vaccine subcutaneously and stated the efficacy cannot be determined since it was given in the wrong tissue.  Concomitant medications were not reported. No treatment information was provided.
Pt. received booster shot at the Hospital on 11/29/21. 11/30/21 around 24 hours later pt experienced arm swelling-states she had a had huge knot, red and swollen, hot to touch. Had breathing issues; states it was difficult to get a deep breath and right eye and shoulder started to swell as well. Patient states breathing is better now, had to take 3 rounds of Benadryl. Can see out of her eye. Still making improvements.
expired vaccine administered with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  Linked to case- 2022SA409871.   This case involves Adult and unknown gender patient who was administered expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received a expired dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation. dose, strength: unknown) (lot UT7325MA, exp: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (latency: same day)  No lab data provided.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.; Sender's Comments:  US-SA-2022SA409871:
Patient did not receive second covid vaccine. Admitted to hospital; Dexamethasone; supplemental oxygen
Patient with head congestion, cough, fever, fatigue, works at the hospital with COVID-19 patients, she has had the vaccine.
11/01/22 presents to ED for "abdominal pain, vomiting, weakness" PMHx of "HTN, dyslipidemia, hypothyroidism"
Started out warm and swollen but kept increasing in diameter and got hot to touch. Went to ER and was empirically diagnosed with Staph infection.
Injection was Thursday and it is now Monday. Injection site is very hot to the touch. Red raised bump at injection site as well. More so concerned over the heat at the injection site.
covid-19; covid-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: 3015513A), in left arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Feb2021 as dose 1, single (Lot number: 038K20A), in left arm and on 03Mar2021 as dose 2, single (Lot number: 025A21A) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient was treated for COVID-19 with paxlovid from 14Jun2022 to 19Jun2022. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
C/o feeling "light headed" after receiving vaccine. Was seen at Medical Center x 3 since vaccine. States "had shakes." Was seen 1 week after vaccine & again following week. Per patient, was dehydrated and fluids were given. Also seen at Medical Center in January, 2015, due to dizziness. Pt. did not receive any diagnosis this visit.
Erythema at the site of injection in thigh. Left thigh 9x7cm; right thigh 6x4cm.
5/5 66y.o. male with ESRD on HD TTS, HTN, HLD, cirrhosis of the liver, chronic Hepatitis B, history of CVA who presented to the hospital with dizziness.
low 02 sats, increased pulse (124) vomited x 1 Chest x-ray on 10/21 showed cardiomegaly with bibaslar pneumonia
Pt received vaccine on 7/29. Seen in office on 7/31 Dx with reaction shot. Injection site red and warm to touch. pt put on KEFLEX. Mom saw no improvement, admitted to hospital for IV Abx.
Didn't feel right in the head; Lower back hurt; Arm was still swollen; Sore at injection site (3-inch diameter); red; Joint pain in knees; Arm was itchy; Red rash on injection site; Felt a bit tired; Arm was sore; Slight headache; Chills; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  slight headache, chills, arm was sore, did not feel right in the head, felt a bit tired, arm was itchy, feeling fatigue again, red rash on injection site, did not feel right in the head again, arm was still swollen, sore at injection site (3 inch diameter), joint pain in knees, and lower back hurt.  The patient's medical history was not provided. Patient was allergic to tetracycline and ampicillin. Concomitant medications reported were methotrexate, hydroxychloroquine,and levothyroxine sodium .  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 307K20A) intramuscularly in left upper arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events,  slight headache, chills, sore arm, she also did not feel right in the head and this lasted for 12 hours. On 15 Jan 2021, the she  felt a bit tired . On 25 Jan 2021, she noticed her  arm was itchy and sore. She started feeling fatigue again. Then she noticed a red rash on injection site. On 26 Jan 2021, she did not feel right in the head again . Her arm was still swollen and sore at injection site (3 inch diameter), red and itchy. She also had  joint pain in knees and her lower back hurt . Treatment details included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were considered unknown for all events except sore arm (not recovered).
Moderna COVID-19 Vaccine.  30 minutes post injection: pain at injection site, burning.  3 hours post-injection: fatigue, 99*F body temperature.  6 hours post-injection: nose and chest congestion, deep coughing.  8 hours post-injection: 100.7* fever, dizziness, restlessness, anxiety, headache. 24 hours post-injection: headache, coughing, rhinitis, sore throat, congestion.  Congestion, rhinitis, coughing continued until 72 hours post-injection.
Pain originated from a nodule on the left arm, radiating tingling sensation to the pinky and ring finger of the left hand, found on the Anthrax injection site. Denies any shortness of breath, nausea, vomiting or dizziness.
This spontaneous report was received from the patient's mother via a company representative referring to her daughter, a 17 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date in June 2016, the patient was vaccinated with the third dose of GARDASIL 9 or GARDASIL (strength, route, anatomical location, lot # and expiration date were noted) for prophylaxis. The first dose and the second dose were administered on an unknown date in January 2016, and on an unknown date in March 2016, respectively. The reporter stated that on an unknown date in June 2016 (same date of the vaccination with the third dose), the patient experienced difficulty with walking, could not open her eyes and twitching like her body was convulsing. The patient's mother reported that she called an unknown name pediatrician, who advised her to go to emergency room. The mother reported that at the hospital's emergency room were unable to do anything for the patient and she was discharged her to home. A few days later everything was back to normal. The outcome of gait disturbance, eye disorder and muscle twitching was recovered on an unknown date in 2016, after received unspecified treatment. The reporter did not assess a causal relationship between the aforementioned events and GARDASIL 9 or GARDASIL. However, the reporter stated that pediatrician felt that this situation had nothing to do with the vaccine.
rash and swelling from the injection site to her wrist one week starting day of injection and lasting until one week later; rash and swelling from the injection site to her wrist one week starting day of injection and lasting until one week later; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender  received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) , via an unspecified route of administration on 23Oct2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that rash and swelling from the injection site to her wrist one week starting day of injection and lasting until one week later. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
patient was meant to receive Pediarix and a standalone HIB vaccine, but PENTACEL was given in error with no reported adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 months old male patient who experienced patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix).  On 11-Jan-2023, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at dose of  0.5ml  lot UJ664AAA at expiry date of 4-May-2023  via intramuscular route in left leg Immunization.  On 11-Jan-2023 the patient developed a non-serious event of patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event (wrong product administered) (latency : same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was meant to receive Pediarix and a standalone HIB vaccine, but Pentacel was given in error with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event.   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.
Received vaccines at 4:30 pm. At 11:00 pm she rolled over in bed and head felt heavy. At 5:30 am she woke up dizzy and the room was spinning. Was able to get up after 3 minutes but was wobbly. Upon arrising on 2nd day felt like she was on a "moving ship". This lasted about 10 minutes.
6 hrs p/vax fever was 104, & pt was very congested fever lasted about 4 days;
I had 4 nosebleeds starting at 14:00 hours [2:00 p.m.]on 04/27/2021 the last one started on and about 23:00 hrs, prompting me to call -my insurance provider's Nurse Hotline for guidance. The nurse suggested to ask my primary care physician, Dr. to run blood work  as she ran a checklist and read to me the possibility of a rare side  effect of the COVID vaccine that was reported, - thrombocytopenia.  My nosebleeds were under five (5) minutes however, it was still a concern. On 04/28/2021 I had a video call with Dr.  After our call he ordered blood work which I had done on 04/29/21.
Nine days after vaccine 7-10-15 noted red raised rash on face, arms, trunk. Worse on trunk. 7-9-15 pt. may have had slight fever. No itching. Went on antibiotics the day after vaccines which was 7-2-15. Mom does not think rash is related to antibiotics.
This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # M004116, expiry date: 12-OCT-2017 (dose and route not provided). The vaccines were exposed to unspecified multiple previous excursions since March 2016 and a current excursion in July 2016 for 15 days exposed to a minimum of 27 degree Fahrenheit and maximum 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 101-102 from 10:30pm on 2/9 to 5:30am 2/11 Rigors Muscle aches Headache Nausea
Breakthrough case admission after 2 vaccines Moderna 3/31/21 Lot# 025B21A;  Moderna 4/30/21 Lot# 048B21A
Mother reports chickenpox, fever of 103F. Has 4 or 5 bumps and had chickenpox vaccine as a baby. She said he had a runny nose and an occasional cough x 2 days. Developed 2 little bumps and had chickenpox vaccine on 2/27/97. Had had fever with this. Exam shows child is alert and cheerful and talkative. He has nasal congestion with scant clear drainage. Has eczematous rash on arms and 2 small vesicular lesions, one on right arm and one on abdomen. Dx: viral illness, possible varicella and eczematous rash. Treat with Benadryl, HC cream and Tylenol. Return if not resolving or if problems.
Myopericarditis; This is a literature report for the following literature source(s):   A 19-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 72 hrs after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Ejection fraction: 59 %, notes: (At admission); 56 %, notes: (at follow-up); 54 %, notes: (At admission); 58 %, notes: (at follow-up); Magnetic resonance imaging heart: No edema.Focal mid myocardial and, notes: near transmural delayed enhancement. No pericardial changes. Hyperintense pericardial signal and thickened pericardium (at admission); no edema,mild focal improvement in, notes: enhancement; hyperintense pericardial signal and thickened pericardium; trivial pericardial effusion (at Follow up 4 Months).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event MYOPERICARDITIS  and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. The 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 notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/drug/event and different patient;