chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose of Pentacel and PedvaxHIB on the same day, which resulted in an extra dose of the HIB component for the patient with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who had received a dose of pentacel and pedvaxhib on the same day, which resulted in an extra dose of the hib component for the patient with no reported adverse event while receiving vaccines PEDVAXHIB and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 23-Jun-2022, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot UJ529AAA and expiry date: 22-Jul-2022) via intramuscular route in unknown administration site for Immunization. On an unknown date, the patient received an unknown dose of suspect PEDVAXHIB not produced by Sanofi Pasteur (strength, formulation was unknown, lot UJ529AAAo and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 23-Jun-2022 the patient developed a non-serious event received a dose of pentacel and pedvaxhib on the same day, which resulted in an extra dose of the hib component for the patient with no reported adverse event (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and (latency: unknown) following the administration of PEDVAXHIB.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Occipital Palsy in right eye : pain in right eye and restricted movement of eye lid and eye ball and blurry vision
Information has been received from an office manager concerning her 19 year old daughter with no pertinent medical history who on an unspecified date in 2008 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# not reported). On unspecified dates, the patient was vaccinated intramuscularly with the second and the third 0.5ml dose of GARDASIL (lot#s not reported). There was no concomitant medication. It was reported that the patient experienced syncope several times between the second and third dose of GARDASIL. Unspecified medical attention was sought. Sleep studies were performed with no results reported. At the time of this report, the patient had recovered. Additional information has been requested.
Received flu shot 10/04/02 & within 20 minutes arm & shoulder hurt, PM 10/05/02 -  arm & shoulder felt like it had a fever, Sunday PM 10/06/02 rash on back, AM 10/07/2002 pustules on trunk of body, legs, neck and in throat. Went to MD AM 10/07/02 & was put on Prednisone orally and cream, Zyrtec & Keflex, Lymph nodes right neck are swollen, blood work done.
Was given Engerix-B and Hyper HepB immunoglobulin at same anatomical site; This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a male patient who received HBV (Engerix B) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included IMMUNOGLOBULIN ANTIHEPATITIS B (HYPERHEP B S/D) for prophylaxis.   On 2nd March 2021, the patient received the 1st dose of Engerix B and HYPERHEP B S/D. On 2nd March 2021, unknown after receiving Engerix B and an unknown time after receiving HYPERHEP B S/D, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The patient was born.  The patient received Engerix B and Hyper HepB Immunoglobulin at same anatomical site on 02 Mar 2021, which led to vaccine administered at inappropriate site. As per schedule it should not be given on same site and the reporter was concerned if that would affect the efficacy of the vaccine. The reporter consented to follow up.
The patient was vaccinated with an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 23-APR-2019, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis, lot # S002459 and expiration date on 15-MAY-2020 (dose and frequency was not reported).   The temperature was of 52.5° for 4 hours and 40 minutes and there were no previous temperature excursion. The call was placed because of a digital data logger report.
got moderna second dose on Friday , feb 13, 2021 at 10:40am.  At 6 pm same day I started fever at 101. I took Tylenol and decided to take it 8 hourly.  Feb 14, I had fever spike upto 104.7 at 6am and 104.3 at 4pm. BP: maintaining at 100/65 PR: 110. Pulse ox 99. Continued Tylenol 8h, added lemonade and other fluids to keep hydrated  To my relief Feb 15, fever was 101 at 6am and 101 at 6 pm.  Afebrile on feb 16 and 17
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: COVID-19 Vaccine and Myocarditis. 2021;00:1-2     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: 65% 65%. On an unknown date, Troponin I: 18.94 ng/ml 18.94 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    Concomitant medications were not reported. Therapy for the event was not reported. It was reported that all patients recovered within 6 days of their presentation with complications. This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications.  This literature report concerns a 24 year old male patient who experienced myocarditis unknown duration after vaccination with second dose of mRNA-1273. The occurrence of the event is consistent with the current understanding of the mechanism of action of the vaccine (known to cause the event).The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-317848, MOD-2021-317975, MOD-2021-317976, MOD-2021-317977 (Patient Link).; Sender's Comments: This literature report concerns a 24 year old male patient who experienced myocarditis unknown duration after vaccination with second dose of mRNA-1273. The occurrence of the event is consistent with the current understanding of the mechanism of action of the vaccine (known to cause the event).The benefit-risk relationship of mRNA-1273 is not affected by this report.
PRESUMED VASOVAGAL SYNCOPE. After Tdap and then Influenza vaccines were administered patient almost immediately became disoriented and then slowly fell forward to the floor. The immunizing pharmacist was able to catch him and slowly guide him to the floor. After some initial confusion he indicated that he wanted to move to a chair to be more comfortable. Patient was sweating and pale in color. He admitted he had not had anything to eat recently so was given popcorn and water which he took. After about 15 minutes where he sat, chatted with staff, and was alert and giving appropriated responses he was able to stand up and was steady on his feet.
Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfizer vaccine (1/5/21 vaccine given). Not sure what the recommendation is as to whether I should still have the second dose. Doctors at the ER were not sure either.
Vaccine given 9am, 430pm, no appetite, achy, chest hurt when breathing deeply "feels like wanted to die." 8pm aches and pain very bad. 1030pm slight temperature. Following day feeling better, back, neck still sore, site of vaccination soft, warm, pink.
Back pain; Joint pain; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 25-APR-2017, the patient was inoculated the zoster vaccine live (ZOSTAVAX)(lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2017 [reported as "shortly after" receiving the zoster vaccine live (ZOSTAVAX)], the patient suffered from severe joint pain and severe back pain. The patient was also diagnosed with shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered.  Joint pain, back pain, and shingles were considered to be disabling.
VACCINE WAS EXPIRED ON 8/9/22, GIVEN TO PATIENT ON 10/7/22
headache; I am stuck in bed; fever of 101; Shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-NOV-2023, the patient received the 2nd dose of Shingrix. In NOV-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache), bedridden (Verbatim: I am stuck in bed), fever (Verbatim: fever of 101) and shivering (Verbatim: Shivering). The outcome of the headache, bedridden, fever and shivering were not resolved.   It was unknown if the reporter considered the headache, bedridden, fever and shivering to be related to Shingrix.   It was unknown if the company considered the headache, bedridden, fever and shivering to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-NOV-2023 The patient was 50 plus in a great health. The day before reporting, the patient had the shingles vaccine and now he/she was stuck in bed with a fever of 101, shivering and headache. The follow up would not possible as no contact details were available.
PATIENT HAD HIVES ON RIGHT ARM, NECK AND FACE.  PT CONTACTED DR AND TOOK BENADRYL ON 10/27/20. PT TAKING CLARITIN ON 10/28/20.    THE HIVES RESOLVED EXCEPT NEAR HER RIGHT EYE.  THE REDNESS ON ARM AND NECK HAS LESSENED BUT THE SKIN IS STILL ITCHY
swollen spot, skin discoloration is starting to mimic my existing skin issues.  swollen. hot, some bruising down arm, bruised to touch in neck no recent injury.
Mother reports a generalized rash appearing 5/4/08 with fever  (103.9) appearing on 5/7/08 with persisting rash.  Seen at Urgent Care center and by personal physician.
Giulian-Barre syndrome with fever; Giulian-Barre syndrome with fever; severe muscle weakness; somnolence; difficulties focusing; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 15:45 as dose 2, single (Lot number: EN6198) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine headache" (unspecified if ongoing); "Hypertension intermittent" (unspecified if ongoing), notes: Hypertension intermittent. There were no concomitant medications. Patient did not receive any other vaccine on same day and not receive other vaccine in four weeks. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 04Feb2021, for COVID-19 immunization, reaction(s): "difficulties focusing and completing tasks", "Guillain Barre syndrome", "fever", "severe muscle weakness", "somnolence". The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), PYREXIA (non-serious), outcome "recovered with sequelae" and all described as "Giulian-Barre syndrome with fever"; MUSCULAR WEAKNESS (non-serious), outcome "recovered with sequelae", described as "severe muscle weakness"; SOMNOLENCE (non-serious), outcome "recovered with sequelae"; DISTURBANCE IN ATTENTION (non-serious), outcome "recovered with sequelae", described as "difficulties focusing". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (13Dec2020) Negative, notes: Nasal Swab; (13Jan2022) Negative, notes: Nasal Swab; (07Mar2022) Negative, notes: Nasal Swab; (27Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of guillain-barre syndrome, pyrexia, muscular weakness, somnolence, disturbance in attention with bed rest, valacyclovir 1000 mg PO QID and ibuprofen 400 mg PO TID. Patient received BNT162b2 (BNT162B2), on 06Feb2022 at 15:45 as dose 3, single (Lot number: unknown) intramuscular, in left arm for covid-19 immunisation.   Clinical course: It was reported that patient experienced giulian-barre syndrome with fever, severe muscle weakness, somnolence, difficulties focusing and completing tasks for 2 and 3 weeks after 2nd vaccination.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event guillain-barre syndrome and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.
About one week later, formed a sore throat for two days. The sore throat became a viral infection diagnosed as pityriasis rosea. Full-body "Christmas Tree" rash and flu-like symptoms. Expected to last 6-12 weeks. First time experiencing this viral infection or anything like it.
Provider used a previously used needle and syringe initially to vaccinate the patient.  No vaccine remained in that syringe.  Vaccinated patient with new needle and syringe that included vaccine after realizing their error.  Patient advised of potential bloodborne pathogen exposure.
I took the shot at 3:00 they kept me there about 45 minutes. I seemed fined, they sent me home. Soreness in my arm but nothing serious. I came home and about 4 hours later I started to feel itchy all over my body. I had some of the normal symptoms, tiredness, arm hurt, chills during the night. The night of the injection my roommate said my face was beet red. The next morning I was itching all over my body and it did go away. That evening, Saturday, it came back with a vengeance, it was every where, even between my toes. It was like hives all over my body and it was the middle of the night so I read a little bit and it said it was an allergic reaction to the vaccine. Which scared me a little bit because after the first shot my throat itched a little bit but it went away. Sunday morning it was worse and everywhere. I called a friend and looked it up and it said take Benadryl which I did and the itchiness went away but the rash  didn't go away, it is mostly in places where clothing is touching. So I decided to report it, it seems like an allergic reaction.
This is a spontaneous report from a contactable certified medical assistant reporting on behalf of doctor. A 79-year-old female patient received PREVNAR 13 (Lot# M06899, exp date Mar2017, NDC 0005-1971-01), intramuscular, on 16Feb2016 at 11:45 am, at 0.5 ml single in right deltoid. Relevant medical history included ongoing hypertension, ongoing cataracts, ongoing hearing loss, ongoing deep vein thrombosis and ongoing hyperlipidemia. Concomitant medications included amlodipine (unspecified trade name), from an unspecified date and ongoing, at 10 mg daily, for hypertension; Aspirin, from an unspecified date and ongoing, at 325 mg daily, for pain; CENTRUM SILVER, from an unspecified date and ongoing, daily for vitamin supplementation; Glucosamine and chondroitin plus, at a 2 DF daily, for vitamin supplementation; hydrochlorothiazide, losartan, daily, for blood pressure high; ALEVE, at 220 mg daily, for inflammation and pain; Apple cider vinegar, at two tablespoons with 8 oz water daily; omega-3 fatty acids (unspecified trade name), at 300- 1000 mcq daily, simvastatin (unspecified trade name), at 20 mg 1x/day for weight loss and no control cholesterol and albuterol inhaler, at 90 ug as needed for asthma. The patient experienced unable to sleep on 16Feb2016 with outcome of recovered on 22Feb2016, arm was hot to touch on 17Feb2016 with outcome of recovered on 22Feb2016, entire arm was painful on 17Feb2016 with outcome of recovered on 22Feb2016, pain at injection site on 16Feb2016 with outcome of recovered on 22Feb2016, hard spot size of quarter on arm on 17Feb2016 with outcome of recovered on 22Feb2016, arm was hard to move on 17Feb2016 with outcome of recovered on 22Feb2016 and redness on 19Feb2016 with outcome of recovered. The patient underwent lab tests and procedures on 16Feb2016 which included: full blood count normal, lipid panel normal. the reporter considered the events related to pneumococcal 13-val conj vac (dipht crm 197 protein). Follow-up (03Mar2016): This follow-up report is being submitted to amend previously reported information: event "injection site mass" recoded to "vaccination site mass". Follow-up (27APR2016): Follow-up attempts completed. No further information expected.
Redness, swelling, and warmth at the injection site, spreading dramatically over the thigh. Measured 11.5 x 12.5 cm at the time of assessment, over the past 24 hours it seems to have slowed its growth, and is less red and warm than it was the day before. Will watch for now but provided a safety net script of KEFLEX if it were to continue to worsen.
administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Crosslinked with MOD21-141427, MOD21-141586, MOD21-141640, MOD21-141641, MOD21-141642, MOD21-141643, MOD21-141644, MOD21-141645, MOD21-141646. There were 9 patients instead of 10 as initially reported.  This case is for the 9th patient. Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-314567, MOD-2021-314573, MOD-2021-314570, MOD-2021-314793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Possible NNI.
Ultra sore arm(immediate).  major bone and joint pain, nausea, loose bowels, very tired, neck pain, foggy brain  headache, fever 100 Went to bed. During the night woke up with chest pain.   Slowly faded as next day passed.
Pt recvd 3 doses of Engerix-B vax & it was determined that pt did not respond; 4th dose of Engerix-B was administered & pt has still not responded;
Nauseated afterwards till night.  Flu-left arm, softball size swelling, went down next day but has stayed sore.  Pneumonia-right arm: knot and still very sore.  Prednisone to treat left arm and augmentin right arm.
High fever for five days; Headaches; Nausea; Chills; Lightheaded; Sore body; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 at 00:00 (Lot number: unknown) at the age of 17 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Diagnosed depression and anxiety and "Anxiety" (unspecified if ongoing), notes: Diagnosed depression and anxiety. Concomitant medication(s) included: FLUOXETINE and unspecified birth control medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown Anatomical site: left arm; Administration time: 00:00), administration date: 25Apr2021, when the patient was 17 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (21May2021 at 00:00), described as "High fever for five days"; HEADACHE (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Headaches"; NAUSEA (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Nausea"; CHILLS (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Chills"; DIZZINESS (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Lightheaded"; PAIN (non-serious) with onset 16May2021 at 00:00, outcome "recovered" (an unknown date in 2021), described as "Sore body". The events "High fever for five days", "Headaches", "Nausea", "Chills", "Lightheaded" and "Sore body" were evaluated at the physician office visit. It was unknown whether any therapeutic measures were taken as a result of the events pyrexia, headache, nausea, chills, dizziness and pain.  Additional Information: The patient had no known allergies. 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. The fever was very hard to get rid of. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.