chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; accidentally injected a FLUZONE HIGH DOSE into an 8 year old patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via call-center via Medical Information (Reference number- 00397824) and transmitted to Sanofi on 17-Dec-2020).  This case involves a 8-year-old patient of unknown gender who had got accidentally injected a FLUZONE HIGH DOSE (wrong product administered) (product administered to patient of inappropriate age) (accidental overdose) while the patient got Influenza Quadrival A-B High Dose Hv Vaccine (FLUZONE HIGH-DOSE QUADRIVALENT) (frequency, strength, lot number and expiry date unknown) via an unknown route for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case as the patient had got ccidentally injected a influenza Quadrival A-B High Dose Hv Vaccine (latency: same day).  At the time of reporting, no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received DTaP, VZV & IPV on (L) arm on 9/23/11 at around 3:30 p.m. there was some bruising noted the following day. Yesterday (9/25/11) got red & swollen & itchy. Slightly increased in swelling & redness. No fever.
Improperly stored administered vaccines; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 03-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S020160, expiration date: 30-JUN-2021 (dose, route of administration were not reported) and improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038175, expiration date: 26-NOV-2021 (dose, route of administration were not reported) both for prophylaxis.  It was reported that the doses of vaccines administered to the patient were not stored properly for the time frame 1 hour and 15 minutes in the temperature between 6 degrees Fahrenheit (F) to 14 F (10F), for 1 hour and 30 minutes in the temperature between 15 F to 46 F (44.8 F) and for 2 hours and 30 minutes in the temperature between 47 F to 77 F (50 F). There was no previous temperature excursion reported. Digital Data Logger was involved.  The outcome of medication error was unknown.
About 5-10 min after vaccine administration - unconsoleable crying, blotching red rash in face.
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
Pt has swelling and redness in the arm for 2 days. Area is about the size of a grapefruit. Area was also felt hard to touch.
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or  guidance.
Vax shots on 6/13. Woke up 6/14 at 02:00. Fever 102.5, nausea, vomiting, shaky, body ache, lower back pain and dizziness.
Employee presented to clinic for a hepatitis B booster vaccine (#4).  Approximately 5 minutes after receiving the vaccine, employee returned to clinic reporting a "scratchy throat," dizziness, and feeling flushed. Employee denied respiratory or breathing problems. No hives or itching. Initial BP at 1355 was 143/92. Employee states normal BP is 90s/60s. BENADRYL 50 mg was given to employee at 1355. BP/HR were monitored during visit: 1400 139/82, HR 75, 1405 126/76, HR 69, 1412 122/78, HR 66, 1430 117/78, HR 62. BP and symptoms were monitored until 1433 when employee was feeling well enough to leave the clinic- she denied dizziness, states her throat felt "clear," and was not feeling flushed. Walked employee out to her father's vehicle to get a ride home from her father after taking the BENADRYL. Employee was discharged after assessed by NP, who recommended that employee continue to monitor her symptoms at home, stay well-hydrated, and call 911 or have a family member take her to the ER if symptoms worsen. Employee verbalized understanding and is agreeable.
Right thigh red warm swollen. ER visit to hospital. Fevers 102.0 and higher. Whole top of thigh red and swollen.
Hives; Itching; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she recieved BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EM9809 and Expiration date ; not supplied) via an unspecified route of administration, on 01Feb2021 (at the age of 79 years) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that She got the first dose 10Feb2021. She developed hives the next day 11Feb2021 and they stayed until she went to the doctor at least a week after and got the Prednisone. She was itching so bad. She says they have recovered at this point but another reason she was calling is that her doctor doesn't want to give anymore Prednisone for the next dose, She said they do not want to keep suppressing it. She guesses she will just have to see what's going to happen or maybe she shouldn't have it. The doctor said Pfizer may tell her not to take it. She does not see any expiration date or NDC number, just reminder for the next appointment. Dose: unknown to the caller. She just knows it was dose number 1 and that they went and got it. She says she thinks she will just follow up with her doctor and she also said to let them know when she gets the shot to watch her longer than 15 minutes, she may call them maybe they will just come up with some other medication to give her if she needs it because they do not want to give her Prednisone anymore. She guesses she will go take it and see what happens. She is sorry she could not find her doctor's address. Oh she found the doctor's information. Just so happens she got a piece of mail from them today. Investigation assessment; no. the outcome of events was recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that on 30-JAN-2014 a patient missed a dose of ZOSTAVAX because of a product quality defect with the ZOSTAVAX vial. The patient was scheduled to receive the ZOSTAVAX vaccine today on 30-JAN-2014, but she hd not yet been able to receive a dose. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of herpes zoster otitis externa in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in late August or early September 2018 without adverse events). In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, less than a month after receiving SHINGRIX, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant). On an unknown date, the outcome of the herpes zoster otitis externa was unknown. It was unknown if the reporter considered the herpes zoster otitis externa to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 88 or 89 years. The patient received 2nd dose of SHINGRIX on left arm sometime in late December 2018. In early January 2019, the patient developed shingles on and around the left ear. She was seen by her physician and was being treated. The reporter gave consent to follow up.
29DEC93 pt recvd vax @ 830AM & 3PM pt called clinic & related having warm feeling @ inject site, no redness noted @ this time; advised to see MD if sx become more severe or persists, advised may take APAP;
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (seasonal influenza vaccine, manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 20, 10, and 1280 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had more than 4 fold increase in titer value and also tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as a LCI case of Influenza A/H3N2. The outcome was not reported.
WITHIN 24 HRS OF 1ST DOSE OF ENGERIX-B, PT EXP NAUSEA, ANOREXIA, LOOSE STOOLS. LOOSE STOOLS ALTERNATING WITH CONSTIPATION PERSISTS (x 9 DAYS AS OF 5-13-90).
A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 12-Jan-2013. The patient experienced FEVER and TESTED POSITIVE FOR FLU A which started on 13-Jan-2013. The outcome of the event of FEVERF and TESTED POSITIVE FOR FLU is unknown. The report was considered to be non-serious.
Received Pneumovax vaccine 10/28/05.  Approximately 4 hours after vaccination, she noticed redness and soreness in arm.  By morning of 10/29/05 - she noted redness from injection site (right deltoid) up her shoulder and down to her wrist. Self-treated with Benadryl and warm compresses and ibuprofen.  By morning of 11/1/01, all redness and soreness had resolved.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Symptons began with a severe headach and progressed to nausea, dizziness and numbness in the mouth and nose area.  I called the pediatrician and they sent me to ER.
Pt presented with tenderness,redness,swelling, hardness about the size of a medium hand. Pt was evaluated by P.A. Early and was prescribed Antibiotics to treat what was called Cellulitis
Pt recvd vax & 9NOV92 exp red wheal @ inject site w/localized itching; did not receive treatment; sx were uneventful;
Pt recv vax on 9/11/98; on 9/27/98 pt exp increased thirst & polyuria; dx=Type I diabetes
Patient reports she was paralyzed from shoulder to arm and severe pain that started within hours of receiving vaccine and lasted a week and is still having pain 5 months later. She went to the emergency room and her primary care doctor for this reaction.
Post vaccination and in recovery recipeint complained of: dizziness, fullness in forehead, cramping in stomach and urgency. States the with the first dose she expereinced 'horrible chills'.  Recipient was observed to be flushed and clammy.  Rapid Response called, recipient transported to ED.
Diagnosed with the Delta Variant after having the Moderna 2 shots; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 16-Dec-2021, the patient experienced COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots). At the time of the report, COVID-19 (Diagnosed with the Delta Variant after having the Moderna 2 shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive, diagnosed with the Delta Variant.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that patient went to the hospital and had an antibody infusion on 16-Dec-2021.  Company comment: This Spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 vaccine. It was reported that the patient tested positive for the Delta variant and he received antibody infusion at the hospital on the same day of the diagnosis, however it is not clear if he was admitted or not. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-452033 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This Spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 vaccine. It was reported that the patient tested positive for the Delta variant and he received antibody infusion at the hospital on the same day of the diagnosis, however it is not clear if he was admitted or not. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Tingling arms legs now stomach  H/o neuropathy from chemotherapy previously resolved  Never had stomach tingling
First COVID-19 vaccine, she didn't have anything but a little bit of a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 08Jan2021 (unspecified if ongoing); "Back injury", start date: 2020 (unspecified if ongoing); "vertebrae crushed", start date: 2020 (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: SKYRIZI [RISANKIZUMAB RZAA] taken for psoriasis. Vaccination history included: Flu vaccine, reaction(s): "Arm swells up". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "First COVID-19 vaccine, she didn't have anything but a little bit of a sore arm.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a little fatigue; her arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 2, single (Lot number: EN6206) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "reflux" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; OMEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (Dose 1, single, Lot#: EN6202), administration date: 28Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "a little fatigue", "her arm was sore".  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a little fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore".  Additional information: She stated she received the first two shots, no problem, the only major thing was a little fatigue, and her arm was sore. No investigations were performed. She was taking a bunch of Vitamin supplements. Route of administration: she stated, "They were all given as shot, is that what you are asking?". In the arm or shoulder, the part above her elbow.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214238 same patient and drug, different dose and similar event;
Caller states he received Moderna vaccine last Wednesday.  Since receiving the vaccine has notice an exacerbation of a condition he has of leg weakness and now with falls.  Instructed to contact PCP for an evaluation of his condition.
Pt woke up 17AUG91 was scratching body all over; Had broken out from head to toe front & back in almost one complete welt, raised approx 1/8in; lasted 2 days; Given DPH & oatmeal bath to soothe itching;
administrated with Bexsero after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number abxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that the patient was administrated with Bexsero after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 28 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter
I had no noticeable symptoms until day 8 when I noticed itching, redness, swelling and heat. Sight measured appr 4 in by 2in. By day 9, the entire upper left arm was involved.  It has improved tremendously however I still have occasional redness and itching in a small area. Overall much improved. I do have pictures of the arm on day 9
2nd dose given early, 17 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (2nd dose given early, 17 days after first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Pt experienced lip numbness and tongue "thickness" between 5 and 10 minutes post-vaccine administration. She was brought to Observation are, vital signs checked and symptoms monitored. 1 dose antihistamine given at 1205pm. She then felt itchiness in throat and ears. 2nd dose po antihistamine given with complete relief of sx's at 1235pm.
Information has been received from a physician concerning a patient who was vaccinated with VARIVAX vaccine (Merck). The physician reported that the office gave a patient VARIVAX vaccine (Merck) when they meant to administer ZOSTAVAX vaccine (Merck). NO AE was reported. It is unknown if the patient sought medical attention. Additional information has been requested.