chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre Like syndrome; bilateral lower extremity weakness with foot drop; bilateral lower extremity weakness with foot drop; This is a spontaneous report received from a contactable physician. A 70-year-old male patient received first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no past drugs, and no concomitant medications were reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05-Apr-2021, patient was hospitalized due to Guillian Barre Like syndrome, stroke work up negative, bilateral lower extremity weakness with foot drop and LP was noncontributory. Patient was being treated with Corticosteroids for the events and was improving. Outcome of all the reported events were resolving. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Gullain Barre syndrome, muscular weakness and peroneal nerve palsy and the suspect drug.  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.
After several days, severe chest pain developed upon waking up one morning.  Pain radiated from the approximate right rhomboid to the sternum.  One saught emergency room care to address the pain after three days of intensification.   A D-dimer test and chest x-ray were performed, both negative for thrombosis.  Upon palpation by the attending physician, the origin of the pain on one's back was localized/identified.  At this time, roughly 12 days post-vaccination, the pain is still present but slowly abating.  IF the pain does not cease soon, one will seek further testing and treatment via a primary care provider.
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Upon leaving the observation area pt noted a short episode of lightheadedness upon quickly standing from chair. Lightheadedness resolved shortly after standing without syncope. Denies chest pain, SOB, difficulty breathing, lip / tongue swelling. Now back to baseline but feels slightly anxious.  Pt reports history of similar symptoms. Vitals: 142/ 84, SpO2 97%, HR 69bpm. No hx of HTN. Recommended pt notify PCP of high reading. Patient comfortable with discharge home.
Itchy "hive-like" bumps on legs and torso, some on arms. No fever or nausea. Have not gone away in over 2 weeks. Patient is going to doctor on 2/27/17.
Chills; Sore Arm; A spontaneous report was received from a 55-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced soreness in the arm and chills.  The patient's medical history was not provided. Concomitant medications were Metoprolol 25mg PO daily.  On 31st Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right Deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, after receiving the vaccine, the patient experienced sore arm and chills. Her BP was 145/74 and HR 136. Treatment for the events were Acetaminophen and she took Zequill for sleeping.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events soreness in the arm and chills were not reported.; Reporter's Comments: This case concerns a 55 year old female patient who received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right Deltoid for prophylaxis of COVID-19 infection and experienced non-serious listed events of soreness in the arm and chills.  Treatment included Tylenol and zequill. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the non-serious listed events are possibly related to the vaccine.
Then a week later my left lymph node swelled; the injection sight swelled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 28Nov2021 at 13:00 as dose 1, single (Lot number: FF2593) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colloidal cyst removal from brain" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Dec2021 at 06:00, outcome "not recovered", described as "Then a week later my left lymph node swelled"; VACCINATION SITE SWELLING (non-serious) with onset 05Dec2021 at 06:00, outcome "not recovered", described as "the injection sight swelled". The events "then a week later my left lymph node swelled" and "the injection sight swelled" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, vaccination site swelling.  Additional information: A week later left lymph node swelled. Still today (8 months later) it is still swollen. treatment: Sonographic evaluation of left breast and axilla. Post and prior vaccination patient was covid tested. Nasal Swab tested type post vaccination.  No follow-up attempts are possible. No further information is expected.
Pt stated that 3 days after their 2nd shingles vaccine she started developing red spots on various parts of her body. Spots were red, flat and a little itchy. They were not warm to the touch. Pt did not report any noted allergies to the vaccine or latex. She did not have any issues with the 1st vaccination. They tried using a prescription steroid cream for relief but it did not work.  It has been about 12 days since the vaccination and the rash had not improved.
This spontaneous report as received from a physician refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 27-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Client stated she was feeling pressure in her right ear and lightheaded. Lead RN made contact with the client at approximately 1305 to assess the client. Client stated that approximately 15 minutes after her vaccination she felt dizzy and had pressure in her right ear and in her chest. She denied any shortness of breath, difficulty breathing, chest pain or swelling of her lips, throat or mouth. Client reported having a history of deafness, Lupus, high blood pressure and an allergy to penicillin which gives her hives. She denied any other allergies to medication/food/environment. Client stated she takes Levothyroxine, Hydroxychloroquine, and atenolol daily otherwise denies any other medication use. A first set of vitals were taken at 1310, blood pressure (BP): 140/80, Heart rate (HR) 72, Respiratory Rate (RR) 14, client's skin was pale and clammy. Client stated her last oral intake was at 0830 and she had a small cup of tea and toast with butter. Client was given a water bottle which she drank and a sugarfree lollipop as she declined the other snacks offered due to avoiding sugars and gluten in her diet. Client stated her BP was normal level for her and that she had been having pressure behind her eyes and in the middle of forehead for a few days due to having elevated BP but denied having the ear pressure prior to vaccination. Client was advised by Lead RN to stay in the zero gravity chair and in observation for an additional 30 minutes for monitoring. At 1320 a second set of vitals were taken: BP 138/78, HR 72, RR 14, skins: normal for ethnicity, slightly clammy with cool fingertips. Client stated the pressure in her ear and chest were persisting but the dizziness/lightheadndess resolved when she laid down in the zero gravity chair. Client stayed in observation an additional 20 minutes and at 1340 stated she was feeling much better and her symptoms of dizzinesss, pressure in ears and pressure in chest had resolved. Lead RN advised client to follow up with PCP regarding ear and chest pressure and gave client ED precautions. Client verbalized understanding and left the observation site on her own accord with a steady gait.
Kinrix was administered to a 16 month old; Kinrix was administered as first dose of DTaP and IPV.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-Apr-2022 Reporter's comment: The medical assistant reported that a patient received first dose of Kinrix. It was the patient's first dose of DTaP and IPV. The reporter did not consent to follow up and declined providing additional information. The expiration date was from agency. Additional Supportive Information: The 16 month old patient received Kinrix and that was patient's first dose of DTaP and IPV, which led to Inappropriate age at vaccine administration and Inappropriate schedule of vaccine administered.
Rash spots on right and left arms. Rash spots on left and right legs. Rash or spots on back and buttocks. Buttock spots have faded slightly
Has patient ever had COVID positive test or diagnosis. If yes, provide date. Jan2022; Has patient ever had COVID positive test or diagnosis. If yes, provide date. Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208) intramuscular, on 31Mar2021 as dose 2, single (Lot number: ER8737) and on 20Nov2021 as dose 3 (booster), single (Lot number: FH8028) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Past drug history included: Cortisone, reaction(s): "Allergies (medications, food and other products) Cortisone", notes: Allergies (medications, food and other products) Cortisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Has patient ever had COVID positive test or diagnosis. If yes, provide date. Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: Has patient ever had COVID positive test or diagnosis. If yes, provided date on Jan2022. Patient stated got first dose of Pfizer vaccine on 10Mar2021, second dose of Pfizer on 31Mar2021, first booster of Pfizer on 20Nov2021, and second booster of Moderna COVID-19 Vaccine on 08Aug2022. Patient was allergic to cortisone. Patient had COVID-19 Positive test or diagnosis on an unspecified date in Jan2022. Patient was not hospitalized due to COVID-19. Patient did not have a history of Myocarditis/Pericarditis. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Friday 4/4/03 OK. Saturday 4/5/03 left thigh swollen red and hot and painful. Giving Tylenol and warm ? Called ? Sunday 1am 4/6/03 awoke screaming-evaluated at emergency dept hospital. Soft tissue involvement only Monday 4/7/03 symptoms resolving.
Information has been received from a physician concerning a 66 year old male who on 26 Oct 2006 was vaccainted with a 0.65ml dose of varicella zoster virus vaccine (lot #0621). On 27 Oct 2006 the patient developed lesions. Unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint was involved. Additional information has been requested.
24 hours post vaccine started fatigue and neck muscle tenderness. 48 hours post vaccine had Right ear pain, right eye pain, Bilateral neck lymph nodes tender, head ache, body aches 72 hours post vaccine same symptoms as the day before with extreme fatigue 96 hours post vaccine slight fatigue 120 hours post vaccine I felt well
Patient reported feeling dizzy and provided with water Patient symptoms improved and family will be driving him home Patient refused medical transport and signed AMA form
MIGRAINE FOR MONTHS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced migraine for months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine for months was not reported. This report was non-serious. This case, from the same reporter is linked to 20211114927.; Sender's Comments: V0:  Medical assessment comment not required as per standard procedure since case was assessed as non-serious
itchy; really hot; big welt at the injection site and to the elbow; burning was the worse, terrific/ little sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), VACCINATION SITE WARMTH (really hot), URTICARIA (big welt at the injection site and to the elbow) and VACCINATION SITE PAIN (burning was the worse, terrific/ little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (itchy), VACCINATION SITE WARMTH (really hot), URTICARIA (big welt at the injection site and to the elbow) and VACCINATION SITE PAIN (burning was the worse, terrific/ little sore arm). The patient was treated with CORTISONE at a dose of 1 dosage form. On 06-Mar-2021, PRURITUS (itchy), VACCINATION SITE WARMTH (really hot), URTICARIA (big welt at the injection site and to the elbow) and VACCINATION SITE PAIN (burning was the worse, terrific/ little sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's have prior experience of same event when she took pneumonia vaccine was provided. Products known to have been used by the patient, within two weeks prior to the event, included blood pressure and thyroids by reporter
This spontaneous report was received from a license practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (strength and dose were not reported) (lot # M032649, expiration date 11-NOV-2018) for prophylaxis. According to the reporter, RECOMBIVAX HB doses were exposed to the following temperatures excursions: 1 hour and 15 minutes between >0 degrees Celsius (C) and <2C, and 3 hours and 49 minutes between >0C and <2C. No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005707: US-009507513-1702USA005706.
Blood on stool, skin drying or rash, joints ache headache, vomits.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284734, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a 17 years old patient who (gender not reported) was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any 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 Directive 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..."
Seeming mild soreness; PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2554760-1. The original narrative from the sender is as follows :  Patient came in to get caught up on routine vaccines. PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine. No reaction noted at time of vaccination. Child tolerated vaccines well. Mom was contacted on 04-JAN-2023 to notify of extra dose and to ask how child was doing. Mom stated patient was doing well with no fever and seeming mild soreness. No concerns from mom other than to ask if child received all the vaccines he needed.  The causal relationship between Vaxelis and the reported event Seeming mild soreness" was not provided.  Due to the nature of the event, the causal relationship between Vaxelis and "PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine" was not applicable.  No further information is expected.
Got shot on 11/14, but arm was very sore. Went to urgent care on 11/30, and diagnosed with adhesive capsulitis.
ON 2/18/00, the pt developed twelve lesions on her neck and no fever. The pt was not seen by a physician but did seek unspecified medical attention. Additional information has been requested.
4/18/2007 AM, injection sites red, swollen, saw MD no treatment given. 4/18/2007 PM, swelling increased, seen in ER, antibiotic injection given 4/19/2007, seen in ER and admitted, released 4/21/2007. 05/15/07-records received for DOS 4/19-4/21/07. DC DX:Cellulitis. Knot on leg and erythema, swelling left thigh.
Covid arm (?) Swelling, rash, and warmth developing at the site of the injection beginning 3 days after vaccination number 2
Pt got rashes on her body and per doctor not sure its because of flu shot or not.
This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There were no concomitant medications, concurrent conditions or medical history reported. The reporter stated that since 05-MAY-2015,, the patients were inadvertently vaccinated with unspecified number of doses of improperly stored RECOMBIVAX HB injection (lot # J005891 with expiration date 20-SEP-2015; dose, strength and route were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.