chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient did not receive a full dose due to the patient squirming during injection/ no AE; the vaccine did visibly leak down the patient's arm./ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00730052) and transmitted to Sanofi on 18-Aug-2021.  This case involves an unknown age and gender patient while received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] then reported patient did not received a full dose due to the patient squirming during injection (underdose) and the vaccine did visibly leak down the patient's arm (exposure via skin contact).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 17-Aug-2021, the patient received a 0.5 mL (total) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (solution for injection) [lot U7140AA, expiry date 04-Nov-2022] via unknown route at an unknown administration site for prophylactic vaccination and reported (latency was on same day) patient did not received a full dose due to the patient squirming during injection (underdose) and the vaccine did visibly leak down the patient's arm (exposure via skin contact).  Details of laboratory data not reported.  It is unknown if the patient experienced any additional symptoms/events.  No adverse event was reported.  It was not reported if the patient received any corrective treatment.  The outcome was unknown for both the events.
Serum-sickness like reaction: low grade fever, fluid in knees, severe swelling of feet
24hours after First vaccine I experienced high heart rate, shortness of breath and dizziness.  Even at night/sleeping I had a heart rate over 105.  It continued  for a week.  I was out of town so I did not seek medical attention.  The following week I started to check my  blood pressure which was elevated along with my heart rate.  My first Dr. visit in regards to this event was 3/25/21.  After an abnormal ecg I was referred to Cardiology.
Parents reports itchiness and rash at sight of injection and back. No fever, resp distress or emesis.
Headache, low grade fever on the first evening. 2nd day until present Redness and extensive swelling at the injection site in Left arm, Headache, fever at injection site. Has been taking Benadryl and Tylenol for reaction. Still on present treatment. As a RN, it looks to me that the injection was not given in the correct site. I am not sure that it has anything to do with the reaction.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 06-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
At around 3:33 pm after HPV vaccine was administered, the patient developed nausea, hypotension (BP 60 palp, HR 50) with perioral pallor and diaphoresis. We closely monitored the patient's vital signs. She was given sweets and cup of water. At 3:45 pm, the patient started to feel better. Her BP went back to 104/69 and O2 sat on room air was 97% the whole time. She was stable and later discharged.
4/05 swelling in hands and feet for 8 months, turned to pain in all my joints. Backache whole body pain. Pain still after over a year at sight shot was given. Flu like symptoms. 01/04/07-records received and reviewed from PCP. Assessment Chronic fatigue secondary to Hep C.  Referred to neurologist.  03/12/07-records received from facility for DOS 3/20/06-referred to consultant in regard to positive rheumatoid factor, impression rheumatoid arthritis.  Reports new problems with pain and subjective swelling involving the hands and feet beginning in spring of 2005 after starting hepatitis B and A vaccines. Bleeding from a venous malformation 4 years ago.  PE: WNL mild tender points in 11 out of 18 areas for fibromylagia. No findings fo synovitis in joint.   Impression: no findings to indicate the presence of inflammatory arthritis, rheumatoid arthritis or connective tissue disease. Chronic depression issues. Pain may be directly related to Hepatitis C. Per 60 day follow: Swelling in hands & feet, joint & muscle pain, fatigue sleeplessness, severe headaches.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 02Jun2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Transgender MTF. See Rx list." (unspecified if ongoing), notes: Transgender MTF. See Rx list. Concomitant medication(s) included: LOVASTATIN oral; FINASTERIDE oral; TADALAFIL; ESTRADIOL; NORTRIPTYLINE; SPIRONOLACTONE; TAMSULOSIN. Past drug history included: Benzocaine ointment, reaction(s): "Known allergies: Benzocaine ointment", notes: Known allergies: Benzocaine ointment; Terbinafine, reaction(s): "Known allergies: Terbinafine", notes: Known allergies: Terbinafine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Positive COVID home test on 14Jun2022; (21Jun2022) Negative, notes: Negative COVID home test on 21Jun2022; (24Jun2022) Positive, notes: Positive COVID home test on 24Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Product Positive COVID home test on 14Jun2022. Took Paxlovid tabs for 5 days starting 14Jun2022 as COVID 19 Treatment and stopped on 18Jun2022. Negative COVID home test on 21Jun2022. Mild symptoms of runny nose stared 23Jun2022. Positive COVID home test on 24Jun2022.
it was rpt from MD whose pt was vax & on 7/8 the MD devel 2 lesions p/ her child also devel lesions
Information has been received from a medical assistant concerning a child who on 27-APR-2010 was supposed to get hepatitis B virus vaccine but was vaccinated IM with 0.5 ml dosed of VAQTA by accident. The patient was not experiencing any known symptoms. It was unknown if the patient sought medical attention. Additional information has been requested.
Was not able to sleep at all last night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Was not able to sleep at all last night) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced INSOMNIA (Was not able to sleep at all last night). At the time of the report, INSOMNIA (Was not able to sleep at all last night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Out come of the event updated.
extreme dizziness about 3 days post vax nausea, bad h/a, body hot then cold;slept x 36hr;
Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, coughing, can't sleep for 8 hours, wake up at 3:30 am.
big red spot on her arm below injection site; A spontaneous report was received from a consumer who was also a 91-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a big red spot on arm below the injection site (injection site erythema).  The patient's medical history, as provided by the reporter, included breast cancer and left breast mastectomy. No relevant concomitant medication was reported.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the patient received her epoetin alfa injection.  On 25 Feb 2021, the patient developed a big red spot on her arm below the injection site.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, big red spot on arm below the injection site, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, the prolonged latency from initiation of the vaccine to event onset along with epoetin alfa injection are considered a confounders.
I started having issues breathing after my COVID shots.  I had blackouts that put me in the hospital I had Cardiology appointments and was diagnosed with supraventricular tachycardia. I'm being scheduled for an Ablation surgery.  All this started w/the covid shots!
Pt developed hives that did spread to  a full body rash. Rash started the next day and progressed for several days. Pt was seen  in clinic on Monday November 18th. Dx was discussed as possible allergy to HPV vaccine or possibly unrelated to vaccine as pt was developed hives several times prior from an unknown source. Pt sent home and was to continue to monitor signs and symptoms and was also encouraged to follow up with an Allergist.
PATIENT DEVELOPED BLOOD CLOT IN EYE. WENT TO RETINA SPECIALIST. WENT TO ER. COROTID ARTERY HAS 80% BLOCKAGE
Patient reported "1st day after getting Tdap my arm was sore but ok. Second day it was horrible. Arm felt heavy like it is made out of metal and concrete all the way down including my fingers. Can't lift it. Hand and lower arm better now. No swelling but tender at the site. No fever.
raised red rash on left bicep, started with itchy sensation, rash has increased in size over the past 22 hours.  Tenderness similar to day after shot is located at closer to armpit.  No other symptoms such as fever or body aches.  I did have a headache the day before (Tuesday 3/9/21)
injection site pain; headache; fatigue; muscle ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered"; HEADACHE (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered", described as "injection site pain"; MYALGIA (non-serious) with onset 16Sep2022 at 13:00, outcome "not recovered", described as "muscle ache". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, myalgia.  Additional Information: Patient had not received any other vaccine in four weeks. It was reported that the patient had not tested for COVID prior and post vaccination.  No follow-up attempts possible. No further information expected.
Patient presented for second vocid-19 vaccine. after receiving vaccine, mother reported that patient had chest pain and grabbed chest and was experiencing leg numbness. Patient's parent reports that prior to receiving vaccine, aptietn has had history of one sided flank pain and tardive dsykinesia induced by medication. After vaccine mother reports patient is experiencing flank pain on opposite side. Mother wanting patient to be seen by provider so patient taken to hospital ED
This case was received from a health care professional in the on 11 August 2009.  This is a case of misuse (wrong route of administration).  A female patient, with no reported medical history, received a subcutaneous forearm injection of ADACEL (lot number not reported) on 10 August 2009.  Immediately after vaccination, the patient had a reaction and the arm turned red.  No additional information was reported.
Patient described over the phone reaction starting a few days after injection. She has hives, rash and itching. It is down her arm to her wrist.
Mother reports "high fever" temp not taken, vomited that day X 1 then none for 5 days, then again, diarrhea since 26Dec90.  Mother did not call & report symptoms until 3Jan91
Approximately 5 minutes following vaccine, jaw/teeth felt tight almost clenched. Had fever x 3 days, uncertain, now high, weakness both arms, right had side of nose started swelling 3 days later after few days that went down. Gums swollen @ same time. Head felt "weird" x 3 days. Patient went back to MD's office, sat and waited x 3 hours to see MD and left, went home  and took Benadryl when unable to see MD.
I woke up early on the 11th and noted I couldn't see correctly out of my right eye. I had seen my Ophthalmologist the prior day and had a routine exam and it was within normal limits. I called him immediately on that Saturday morning and went to see him. He had taken pictures of my retina on the previous day, and he repeated it that day and saw there was a change in the retina artery and felt it was indictive of an embolic event, I was place on Baby Aspirin and was referred to a Cardiologist. I also talked to my primary care physician. I saw the Cardiologist; I am scheduled for a test this Tuesday.
Site: Pain at Injection Site-Medium, Additional Details: Patient left a customer survey stating he was experiencing pain after a Pfizer Bivalent injection. Injection was given on 01/05/2023, the original complaint was received 01/08/2023.On 01/22/2023, customer replied again stating he was still experiencing "a level of discomfort that has caused concern" and he believed it would be prudent to consult with a physician.Pharmacy manager attempted to reach the patient via phone number on file, left a voicemail asking for a return call to get further info
Large red rash, skin slightly firmer to the touch where it's red. Only itched slightly the first day I noticed it. It spread the second day (today).
Sings of fever and injection site swelling; Sings of fever and injection site swelling; This spontaneous report was received from a pharmacy technician, a 30-year-old male patient reporting on himself. His medical relevant history was not reported.  The patient's concurrent conditions included diabetes and hyperlipidemia. His concomitant medications included rosuvastatin, lisinoplril and insulin lispro (HUMALOG). The patient had no drug reactions or allergies.   On 11-SEP-2019, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX 23), intramuscularly, (strength, dose, frequency, lot number and expiration date were unknown by reporter) for prophylaxis.   On 12-SEP-2019 (also reported as "the following date"), the patient experienced having signs of fever (pyrexia) and injection site swelling. The reporter also stated that self-blood glucose checks were performed to him, at home.   At the reporting time, the patient was recovering from the aforementioned events.   The reporter did not assess the causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX 23) and the events occurrence.
Trouble moving her left arm started hurting same day continued to hurt went to walk in clinic. She has fluid in her arm.
HCP reporting an improperly stored vaccine was administered to a patient.; No additional AE.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W002601, expiration date: 24-JAN-2024, for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -11.8 Celsius degrees for 1 hour and 45 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse event).
Approximately 20 hrs following administration, patient presented at  stating a reaction from the COVID vaccine. She described something occurring in her mouth and it was difficult for pharmacist to determine if she had a sore throat or slight swelling in mouth.  clinic is only 2 mins from pharmacy and patient was comfortable driving there for assessment. Pharmacy called clinic to alert that she was coming (12:30pm). Pharmacist called patient at 3pm - patient reported receiving Benadryl and something for nausea. She was napping but ok. She reports having Benadryl at home if needed to repeat. We discussed getting doctor's approval before administering 2nd dose
inc irritability-unconsolable for 4-5 hrs approx 4 hr /p recving immunization.
1145 vaccine administered 1147 patient stood up from chair and then had syncopal episode. Fell face first onto floor. Hit head on wall trim on the floor. Eyes dilated, fists clinched, arms and legs shaking , not responding to verbal cues. Seizure like activity last approximately 1.5 minutes 1150 called 911 1200 ambulance arrived on scene. patient c/o lightheadedness and needing to continue to lay down 1210 transported patient to ER at Hospital
My arm was sore that night November 4th, 2021, the next afternoon at about 4pm I had chest pain. I called my Cardiologist who refilled my Colchicine. Within thirty-six hours of taking the medication the pain is gone. I still have shortness of breath but that gets better after using my inhaler. I will see my Physician again tomorrow morning, November 11th, 2021.
vaccine used past the 12 hour window of use after vial punctured. Stored in fridge entire time and cleaned between each use with alcohol. second dose given 7/14/21 also given past 12 hour window, vaccine same lot number but different vials. Pt contacted and no adverse reaction, pt states no problems
LOST SMELL AND TASTE LOTS OF FATIGUE SORE ARM ACHY BODY SLEEPINESS
This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis.        It was reported that, M-M-R II, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002384: US-009507513-1705USA002382: US-009507513-1705USA002383: US-009507513-1705USA001712: US-009507513-1705USA002381:
numbness in rt hand starting 2.5hr p/vax cont for 3 days & hasn't had any other problems;
Hospitalized (11.10.21 - 11.14.21);  COVID-19 positive (11.10.21);  Fully vaccinated  Admission Date: 11/10/2021 Discharge Date: Nov 14, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxemia (HCC)  COVID-19 virus infection  Pneumonia due to COVID-19 virus  HOSPITAL COURSE: Patient is a 62 year old man who presented for 8 days of sob and fever with nonproductive cough.Patient had tested positive as an outpatient on 11/4 and confirmed again on 11/10. Patient was admitted and placed on dexamethasone/remdesivir/and azithro/rocephin for superimposed bacterial pneumonia. By the time of discharge patient was on RA at rest and requiring 2L O2 with activity. At the time of discharge patient was eager to be released and feeling improved.
Eye twitching and swelling six hours after administration of second vaccine. I have no face fillers or surgeries on face.
Received vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Haemophilus influenzae type b vaccine (batch number 242A7) for prophylaxis.   On 04-JAN-2023, the patient received Haemophilus influenzae type b vaccine. On an unknown date, an unknown time after receiving Haemophilus influenzae type b vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Pt called 11/10 to report evening before was getting ready for bed. Noticed arm red, hot , hard and swollen. Today 11/10 arm is sore and red - no fever. Just hurts a lot; difficult to move. Advised ice, Tylenol - monitor for a day if worse or fever have evaluated. 11/14 Talked to Pt; symptoms resolved by 11/12; no problems since.
Headache, dizziness, nausea, increased Bp.  OTC Advil and Tylenol. Rx Meclizine, Zofran. Spoke with covering  PCP upon her recommendation took an extra HCTZ dose.
I had localalized pain after the injection, but yesterday (6 days post receiving the Moderna shot) I developed a large lump at the injection site. It is raised, tender to the touch, warm to the touch and itchy.
Muscle/tendon/arm pain for 2 months now can't sleep on left side due to aching pain when putting on clothes/jacket requires backward/upward arm motion.
My period began 5 days early, however it is not menstrual blood. It is regular blood. Bright red, thin, and washes out of clothes easily, unlike menstrual fluids which are viscous and more crimson in color. Basically I just started bleeding and I am still bleeding. The flow is constant and heavy. I am bleeding through every 2 hours.