chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023  to 10-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023  to 10-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023  to 10-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023  to 10-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023  to 10-JUN-2023).    Concomitant medication was not provided. Suspect product dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023. Treatment information was not reported. This case contains information about patient 8th out of 14 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:master case
muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/"dropping face"; felt like she was going to have a stroke; feeling "tingles" and numbness all over her body; feeling "tingles" and numbness all over her body; belly pain; going to throw up; feeling that heaviness; bad feelings; "heavy" headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient would like to know if it is safe for her to receive her second dose following the symptoms she experienced after the first dose. The patient reported that 17 hours after the first dose, she had the muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/dropping face. The patient added that before that she was feeling "tingles" and numbness all over her body, including going to her head and "very strong" in her left side, stating it felt like she was going to have a stroke. The patient also states she experienced these feelings in her hand as well. Caller also reports belly pain, was going to throw up. She states that after 2 hours, the "dropping face" was a lot better and had "bad feelings" but slowly disappeared. She states the only thing she experienced after that was a "heavy" headache, but not constantly. She reports that since an unspecified date she has just been "feeling that heaviness." The outcome of the event feeling "tingles" and numbness all over her body, "bad feelings" was recovered, for the event muscles on the right side of her face "kind of fall", stating it was in her eye and her cheek was "kind of down"/"dropping face" was recovering while for the rest of the events was unknown.  Information about lot/batch number has been requested.
I have seen 23 specialists, 6 hospitals with over 240 medical appointments. Often in emergency room for debilitating chest pains, chest tightness, shortness of breath, spiking headaches and nausea. I have undergone extensive treatments and testing from MRI's, CAT Scans, ultrasounds, EKGs, x-rays, electro-acupuncture, dry needling, occipital nerve blocks in my head, Ajovy injection in my thigh, Lidocaine injections on my eye bone, Reiki, chiropractic care, neuro biofeedback and tons of bloodwork. My menstrual cycle is now irregular and one breast started to swell July 2022 and now I am asymetrical! I have Autonomic Dysfunction now with shortness of breath - air hunger, to temperature swings from chills to roasting.  I am nauseous at least five days a week. I have constant fatigue, muscle weakness, hot flashes, and on the worst days, blurred vision! I have blacked out falling down a set of concrete stairs in high school in front of my classmates. I nearly passed out on the track field, my heart pounding and my gums buzzing, my face numb and arms tingling within minutes when the pediatrician put me on an Albuterol nebulizer, later rushing to the emergency room. My heart sometimes pounds to 170 beats per minute without prior activity. I am dizzy when standing up. I have debilitating fatigue and have had to use a cane to get around as a teenager! I have brain fog and find it very difficult to concentrate. I sleep long hours and many times cannot get up without dizziness and nausea. I've missed tons of school because of this especially chest pain, chest tightness, shortness of breath, lightheadedness and extreme fatigue. I have Postural Orthostatic Tachycardia Syndrome (POTS). I now have to take 2,000mg of salt a day to function in spurts. I used to work professionally but have had to stop because I have no energy. I used to be a great athlete but had to stop track and tennis. I was an active, healthy child growing up with normal sleep routines and phenomenal energy. My teenage years have been sucked away with this chronic pain.
This spontaneous report as received from an other health professional (registered nurse) refers to a 3 months old male patient with sickle cell trait. The nurse was reporting the patient developed induration and discoloration at the injection site of the left anterior thigh after administration of his first dose of PEDVAXHIB (lot #0130AE, exp. date 28-JUN-2014) 0.5 ml intramuscular on 14-AUG-2012. The patient was treated for the adverse events (the treatment was not specify). On 23-OCT-2012, the patient's parent called the office to report the induration and discoloration at the injection site were still present but were slowly resolving. Additional information has been requested. This one of several reports received from the same source.
I woke freezing, chattering teeth. Later my heart rate was staying between 112 and 122 but dropping sometimes to 69, most of the time 122. I started running a fever that hit 101.5. I took tylenol to reduce pain and fever. Now, next day, no fever but my right set of toes are odly numb.
chills beginning @ 5hr post vax then fever to 103 x 36hr;mild myalgias;mild abd discomfort;
I was 2 in a half hour episode of double vision.  And it occurred when I was on a trail ride. With the tour guide narration.  I had absolutely no other symptoms.  It lasted about 2 ½ hours.  I saw my Optometrist first.  Then I saw my PCP.  It has not been resolved.  It only happens now at ball games.  I have linked it to the noise.  Now my blood pressure is way high after a ball game as well.  My blood pressure has not gone down at all, and I have had to triple my Lisinopril medication.  I have not been back to a ball game I am going to another one on Saturday.
Site injection soreness; General malaise; Tiredness; This non-serious case was reported by a physician and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Site injection soreness), general malaise (Verbatim: General malaise) and tiredness (Verbatim: Tiredness). The outcome of the injection site pain, general malaise and tiredness were resolved.   It was unknown if the reporter considered the injection site pain, general malaise and tiredness to be related to Shingrix.     It was unknown if the company considered the injection site pain, general malaise and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2023 This report was submitted via the online direct entry reporting system by gsk site. This case was reported by a doctor, who was giving a speaker program on behalf of GSK/Shingrix and mentioned that when got the shot that he some tiredness and injection site soreness. At the program the PI (patient information) was provided. The reporter stated general malaise and site injection soreness as not serious. The reporter did not consent to follow up.
increased migraines with new atypical features ataxia and vertigo now numbness in hands and feet
Patient received vaccine one month early: #1 Shingrix 7/12/2023 #2 Shingrix 8/11/2023
He was supposed to receive PREVNAR 13 but received PNEMOV AX 23 instead; Caller stated her son just had PNEUMOV AX 23 in October of 2020; This spontaneous report as received from a consumer (patient's mother) and refers to an adult male patient. His concurrent conditions included crohn's disease. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On an unknown date in October 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 02-NOV-2021, the patient was was supposed to receive pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) but he was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (wrong product administered and extra dose administered).
1st day of vaccine had a high temp of 110 took Tylenol to break it and the following month she had bad stomach issues, migraines for 3 days, weakness in both legs, pain in left leg.
Patient passed out for about a minute four minutes after receiving the vaccine as she sat outside on a chair waiting for 15 minutes to elapse. Called 911. Before they came patient was awake and responding. Said she could not remember anything.. Left for home with dad who brought her in for vaccine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after receiving vaccine, he tipped forward in his chair and hit his head on counter in front of him. 2 minor laceration on forehead and cut upper lip.  Pt unconscious for less than 1 minute.  Blood pressure taken about 5 minutes later and was 65/40.  911 was called and paramedics arrive on scene.  Care was transferred to them
anaphylactic reaction; This is a spontaneous report from a contactable physician. A patient of an unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not provided. It was reported that the patient had an anaphylactic reaction to PREVNAR 13 on an unspecified date. The physician would like to compare the ingredients in the Pfizer BioNtech COVID vaccine and was asking for a list of ingredients for PREVNAR 13. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The association between the event anaphylactic reaction with PREVNAR 13 can not be fully excluded.  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.
extreme joint pain, shoulders, neck, hands, brought on rheumatoid arthritis, 2n shot excellarated it more.
TOOK UNREFRIGERATED LAST DOSE; This spontaneous case report (PVX2019-2493) was received from a consumer on 04-Oct-2019. It described a 26-year-old female consumer who "took unrefrigerated last dose" (PT: Product storage error), while being on oral Vivotif for typhoid prophylaxis.  Case report: The consumer started Vivotif (one capsule every other day, Oral) on 25-Sep-2019. She took her second and third dose on 27-Sep-2019 and 29-Sep-2019 respectively. She accidentally left the last dose unrefrigerated for 2 days at 68-degree Fahrenheit to 70 degree Fahrenheit. She took her last dose on 01-Oct-2019.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated last dose" was considered as not applicable.
Fever 103.2 max Swollen lymph nodes in right under arm- lasted 12 days
21OCT sore arm, 22OCT sore arm, fever 102, itching called pt called hlth unit spoke w/RN advised to see MD;rash;went to MD w/whelps & itching given med;through up, went to ER;whelps got worse;
Angioedema of left arm at the inoculation site; Pruritus; Inflammation; Pain; edema; Lethargy; arthralgia/shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 20Apr2021 at 11:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included penicillin allergy, HAE (hereditary angioedema), endometriosis, narcolepsy and depression, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received NSAIDs for an unspecified indication on an unspecified date and experienced allergy. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 30Mar2021 at 16:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Concomitant medications (other medications in two weeks) included bupropion, desvenlafaxine, oxybate sodium (XYREM) and icatibant, all taken for unspecified indications on unspecified dates. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. On 20Apr2021 at 13:15 the patient experienced angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain. The clinical course was reported as follows: "Angioedema of left arm at the inoculation site. Diameter of 70 mm. Pruritus subsided within 72 hours. Inflammation remains at present: Approx 96 hours after injection. Pain accompanies edema when pressure is applied. Lethargy and arthralgia for 72 hours. Shoulder joint pain. Note: patient's arm is thin; angioedema extended from anterior to posterior sides of the arm." The patient did not receive treatment for the events. The clinical outcomes of the events angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain were recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.
10/28/2020:  She states initially had pain at injection site. She also has had some pain radiating to left scapular area as well as down to her thumb.   She went back to her office and became nauseated /queasy and felt lightheaded x 1 hour.  3 hours post injection, she has decreased shoulder ROM Limited with flexion and abduction, external rotation, and horizontal adduction Hurts with movement. Currently, using anti-inflammatories, icing.  11/02 -Reports that shoulder is improving; however, there is pain with sleeping. Reports that if she doesn't do ROM exercises hourly, increased pain Pain with flexion, abduction, and horizontal adduction, but ROM is improved. Strength is ok.   12/14 - Shoulder continues to be bothersome - Appointment made with Ortho Plan:  Continue home exercise program          RX:  Celebrex          Recheck 2/15/2021
Pt reported pain in arm for few days seen by physician and treated for abscess. Pain continued & pt given MRI on shoulder. Pt reported to pharmacy she was diagnosed with "deltoid tendonitis".
Vaccination adverse reaction; I have a stiff neck; It kind of itches where they gave me the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), MUSCULOSKELETAL STIFFNESS (I have a stiff neck) and VACCINATION SITE PRURITUS (It kind of itches where they gave me the shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (It kind of itches where they gave me the shot). On 07-Nov-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I have a stiff neck). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), MUSCULOSKELETAL STIFFNESS (I have a stiff neck) and VACCINATION SITE PRURITUS (It kind of itches where they gave me the shot) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Patient didn't experience any event for first two dose, while after receiving the booster patient experienced a kind of itchy where he got shot, later patient had stiff neck, he had the wondering if its side effects. Patient is allergy to Penicillin and he has pulse and it was 58-59 which was a good, Patient self treat for his arm for the itchiness by massages on arm.
Information has been received from a RN concerning her 41 year old Asian female who works with computers with no allergies and no medical history who on 21Jun2003 was vaccinated IM with a first dose of varicella virus vaccine live. There was no concomitant medication. ON 01Jul2003, 8-10 days after the initial vaccination, the pt developed a rash, swelling at the site and 3 blisters on her chest. On 07Jul2003 the pt was seen in the physician's office and the physician noted healing of the blisters, and some swelling at the vaccine site with scabbing. No treatment was needed. The pt recovered and it was reported that the pt is now "fine". On 24Jul2003 the pt was vaccinated with a second dose of varicella virus vaccine live with no reaction noted. There was no product quality complaint was involved. No further information is not expected.
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 13Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myelodysoplastic syndrome" (unspecified if ongoing); "polymyalgia rheumatica" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "diatestes" (unspecified if ongoing), notes: diatestes. Concomitant medication(s) included: UNITHROID, start date: 01Jan2020; LOSARTAN, start date: 01Jan2020; DICYCLOMINE, start date: 08Oct2021; ISOSORBIDE, start date: 01Oct2021; ESOMEPRAZOLE, start date: 01Jan2020; CETRIZINE, start date: 01Jan2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 01Aug2022 to 05Aug2022, amoxicillin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional. This case involves Child patient (age and gender unknown) who accidentally received expired vaccine DAPTACEL. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that accidentally gave an expired dose of DAPTACEL to a child. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.