chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 8 December 2009 the subject received unspecified dose of ENGERIX B (.1 ml, subcutaneous, right arm). On 8 December 2009, at the time of vaccination with vaccination with ENGERIX B, the subject experienced wrong vaccine administered. Less than one month after vaccination with ENGERIX B, the subject experienced nodule injection site. This is second of three cases in which a nurse reported the subjects inadvertently received ENGERIX B instead of PPD. ENGERIX B was administered subcutaneously on 08 December 2009. Two subjects returned on 24 December 2009 and one subject returned on 28 December 2009 reporting a reaction of "knots at the site". At the time of reporting the outcome of the injection site nodule was unspecified. Please see cases A0836972A and A0836976A for the additional two reports with ENGERIX B.
Covid vaccine given at 1133. 1140 patient began c/o itching on his back; exam revealed several reddened areas on his mid upper back with very slightly raised urticaria. Denies SOB, nausea, or any other complaints. 1200 Dr notified and came to examine. At this time itching had stopped, urticaria and redness were decreased. Order rec'd for Benadryl 25mg PO x 1, given at 1225. Pt left at 1240 with decreased redness, no hives, no itching. Instructed to go to ER is symptoms return and call 911 for dyspnea. Chart updated with Covid vaccine allergy.
The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-2023; No Adverse Event; 3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-2023) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient 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.     Patient did not had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 21-May-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. On 21-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A) and PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-2023).    Dosage text was reported as unknown. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant information was reported. The vaccine use by date was reported as 18-May-2023. The administration date of 3 vials was19-May-2023, 21-May-2023, 25-May-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727536, US-MODERNATX, INC.-MOD-2023-727687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727536:same reporter US-MODERNATX, INC.-MOD-2023-727687:same reporter
Initial and follow up information has been received from a certified nurse midwife and a nurse for the Pregnancy Registry for GARDASIL concerning a female (age not reported) who in July 2007, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. The certified nurse midwife reported that the patient was already pregnant (about 20 weeks gestation) when she received her first dose of GARDASIL. The patient sought unspecified medical attention. No other symptoms were noted. There was no product quality complaint involved. On 06-JUN-2008 a follow up telephone call was made to the doctor's office to know the patient's pregnancy outcome information and a telephone message was left. ON 11-JUN-2008 a nurse called back and reported that the patient had a primary cesarean section at term on 31-JAN-2008 and delivered a healthy and normal male baby weighing 7 lb, 10 oz. The baby's apgar score was 9/9. It was reported that the reason for the C-section was arrested descent in second stage with fetal intolerance to labor resulting in multiple deep variable decelerations. No complication was reported. Upon internal review patient having arrested descent in second stage of labor and fetal intolerance to labor resulting in multiple deep variable decelerations which required a cesarean section delivery were determined to be other important medical events. Additional information is not expected.
1/8: disseminated, itchy painful raised rash, most concentrated on occipital scalp and posterior ears, neck, groin and legs. 1/9: soreness and stiffness of bilateral hands and wrists, combined with mid-chest pressure. Intensification of joint pain and subsiding of rash until 1/12, when right hand and wrist were excruciatingly painful, then 1/13 was excruciatingly painful. Intensity of arthralgias has lessened since starting Prednisone taper 1/12.
About 2-3 hrs afterward, pt started having body aches, sore throat, chills, fatigue, nausea and joint pain.
Pt received 3 vaccines, Tdap, MCV4P, and HPV. Tdap and MCV4P were administered first on L arm and HPV was administered last on R arm. Pt fainted right after HPV was administered. Per mother pt had fainted previously with blood drawn but never with vaccines. Pt was kept on observation for 20 minutes with normal BP, respiration, and pulse. Pt had a fast and successful recovery.
Extreme muscle soreness, weakness extending down arm, decreased grip strenth. Taken Ibuprofen, applied heat/cold. Minimal relief provided X5 days.
This spontaneous report as received from a pharmacist via a company representative refers to a 64 year old female patient. Medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, concentration and dose were not reported). No concomitant therapy was reported. On an unknown date the patient developed lesions on her hands and feet. On unspecified dates, the patient went to a dermatologist and physician and she received unspecified medications to treat the adverse symptoms. The outcome of the event was unknown. Additional information has been requested.
Vaccination adverse reaction; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In November 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). In November 2021, IMMUNISATION REACTION (Vaccination adverse reaction), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.     Concomitant product use was not provided by the reporter.  In November 2021, the patient had a Moderna booster vaccine. He stated that approximately 12 hours later he experienced chills, headaches, and fatigue. He had no reaction to the first two vaccines. Lasted for approximately 24 hours.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's Causality for Rinvoq (Upadacitinib) for the events of reaction to covid vaccine booster, headaches, fatigue, and chills was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt recvd shot on 7APR92 w/in 1 hr pt started having sx of limpness, fever (100-104), lifeless, gray color & later was sleeping all the time; to ER 8APR & adm to hosp; MD stated allergic rxn to shots; pt hooked to IV's;
Pt's arm began swelling on day 1. On day 2 her left upper shoulder near the injection site swelled about 3 inches in diameter. She developed a fever of 101.6 and very red hot cheeks.
Day of vaccination - arm very painful. Next day - arm very sore, warm to touch, swollen, erythema, fever 103 - lethargic. Urgent Care dx with infection of arm, put on Cefelexin. Pain, redness, swelling from shoulder to elbow continued returned to PCP office - put on different antibiotic, reported to our clinic 4/11/07.
1st Shingrix dose on 09/20/2019 / 2nd dose of Shingrix on 04/19/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 11th December 2021) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 20th September 2019.).   On 19th April 2021, the patient received the 2nd dose of Shingrix. On 19th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follow: The patient received her 2nd dose of Shingrix, later than the recommended schedule,  which led to lengthening of vaccination schedule. The reporter consented to follow-up. The reported batch number 95R5 was not available in sales data sheet, hence updated to 95R52.
on 10/08/2021 we received a call from a nurse that the patient was found dead in her bed. she was not having any ailment prior to that.
Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine); Little itchy upper body (After second vaccine); Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Little itchy upper body (After second vaccine)), LYMPHADENOPATHY (Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine)) and RASH (Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     The patient's past medical history included Disseminated histoplasmosis, Pneumonia and Intervertebral disc disorder (Disc problems). Concurrent medical conditions included Blood pressure high (Controlled) and High cholesterol (Controlled). Concomitant products included METOPROLOL, EVOLOCUMAB (REPATHA), ESCITALOPRAM and FLUCONAZOLE (DIFLUCAN) for an unknown indication.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced PRURITUS (Little itchy upper body (After second vaccine)) and LYMPHADENOPATHY (Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine)). On 26-Jun-2021, the patient experienced RASH (Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine)). At the time of the report, PRURITUS (Little itchy upper body (After second vaccine)), LYMPHADENOPATHY (Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine)) and RASH (Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine)) outcome was unknown.            On 09-Aug-2021, the patient visited the Emergency Room (third Contact) and was prescribed with Triamcinolone cream and Diflucan pills by mouth.
injection site still sore; diarrhea; nausea; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via Database. The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24May2021 12:00 (Lot number: EW020) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Kidney probelm" (unspecified if ongoing); "Heart problem" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "covid-19", start date: 15Jan2021 (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "injection site still sore"; DIARRHOEA (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "diarrhea"; NAUSEA (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, diarrhoea, nausea, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
low fever (38 C) from 8 - 36 h after dosing; chill; headache for 3-4 days after dosing; arm injection site pain for 2 days after dosing; This is a spontaneous report from a non-contactable consumer. This 32-Years-Old male consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via an unspecified route of administration on 17Feb2021 (at 32-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have covid prior vaccination, was not tested for covid post vaccination and had no allergies. On 17Feb2021 the patient experienced low fever (38 C) from 8 - 36 h after dosing; chill; headache for 3-4 days after dosing; arm injection site pain for 2 days after dosing. No treatment was received. On an unknown date in 2021 the patient recovered from fever and chills. The outcome of headache for 3-4 days after dosing and arm injection site pain for 2 days after dosing was unknown.  No follow-up attempts were possible. No further information was expected.
A report was received from a health care professional on 12/19/03 concerning a 3.5 year old vaccinee of unknown gender who inadvertently received Fluvirin vaccine on an unspecified date in December 2003. On an unspecified date in December 2003, the vaccinee received Fluvirin. No adverse event was observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
vomiting; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: the reporter mentioned that the patient (husband) had his first Pfizer shot 8 days ago and he got really sick and vomiting, and asked if that is related to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient did not experience any adverse physical side effects. The patient was administered an expired dose of Moderna. The dose expired at EOD on 1/3/22 and was administered at 1140am on 1/5/22.
Patient came in 10 days after administration and stated that on the night of administration she experienced "chills" and felt sick all night and couldn't sleep....she didn't know if she had a fever or not. She stated that she was fine on the day she came in to report.
After receiving vaccine client states she has tingling and numbness in the arm which she received the vaccine.    Client states she feels better.  Client discharged home
Patient's husband notified the pharmacy roughly around 12:20pm on Saturday 8/15/20 that his wife didn't feel well several hours after receiving IMZ on Friday 8/14/20. Husband mentioned chills, fever, and being lethargic but can't sleep. Patient hasn't eaten since the day before and now she's finally able to sleep. I advised patient's husband to monitor her fever, keep her hydrate and provide apap if she still has fever. If fever and symptoms doesn't get better to call MD/emergency. Patient husband thinks the pneumonia shot made her ill, but that is not 100% because patient received flu, shingrix, and pneumonia all
Sharp right shoulder to elbow pain for three days, 6 inch by 3 inch swelling above muscle with heat and swelling treated with ice pack from 10/18/2017 until 10/20/2017. Still have red scaly skin that itches.
About ten minutes after getting the shot I got a weird feeling in my chest and then within a few minutes a rapid heart rate.  My normal heart rate is around 72 and my heart rate after the shot was 110. The symptoms lasted for about an hour. In 2011 I experienced the same exact symptoms from intravenous benadryl and the both contain Polyethylene glycol.
Patient stated felt like she had sore throat.  Felt it was slightly difficult to swallow saliva.
On Sept. 19, 2011 I received pneumococcal vaccine booster. The shot was extremely painful and my shoulder and arm were extremely sore that day and through the night. The next day, I had an appointment with dermatologist and she pointed out a reaction on my arm - she described it as hives - red welts running toward my lymph node under my arm which she said was enlarged - finally on this the 4th day after day after the shot, the hives are disappearing around the site of the shot, but there is still some soreness around my shoulder area and under my arm near the lymph node. I have begun to have some mild itching in these areas which I did not have previously - lots of heat on shoulder - feverish. This whole experience was very painful and frightening. I have been doing research on-line at reputable sites and can find very little on my strange reaction. I did find one site that mentioned that boosters can sometime cause a reaction. I find it sad, the so little research has been done on vaccine reactions for boosters. There need to be more clarification on booster shots for folks over 65 who have had shots five years earlier - did I indeed need this shot. Doctors should have more specific guidelines. As far as I know the first vaccine I received did not cause a reaction, so why did I have one on the second. Another recommendation - I was not given an info sheet on this vaccination, nor was I told about the possible side effects. I called my doctor when I had the reaction, and did inform him that I would help out by sending in this form for them - I downloaded it off the internet.
Had swelling on the facial area; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2374944-1. The original narrative from the sender is the following:  Patients mother called clinic this morning, 07/20/2022 and stated that patient had swelling on the facial area. Patients mother stated that it just began when she woke this morning. Mother stated that patient was acting normal and had no signs of dyspnea.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Had swelling on the facial area".  No further information is expected.
No issues except a sore arm for one day after the vaccination, but 7 days later a small red, itchy,  warm bump appeared under the injection site.  Resolved within 24 hours.
The Patient is a 11 year old male.  Source of patient information was patient.  Source of patient information was mother.  Presents for L arm vaccine reaction. Had Mcv vaccine 2 days ago. Yesterday mother noted small area of redness. Today redness, swollen, hot and hard, significantly worse. Intermittent itching. Pain only with pressure and hyperextension. Motrin, not effective. Good ROM of arm. Denies fever, numbness or tingling. Good appetite and energy level. Denies NVD. No other concerns.
Same day felt chills, then felt hot - then next morning felt nausea & had diarrhea. Day after shot started having trouble focusing eyes, blurry vision symptoms persists. Referred patient to PMD.
From 12:30PM to 8:30PM i felt okay. From 9PM, I started feeling cold, got headache, felt weak and eyes started getting heavy at 3AM - I woke up because of severe headache. I also felt cold, and believe I had fever. at 6AM onwards - I felt very weak that I could barely get up in bed. Headache was severe. Still got fever. I lost my sense of smell and taste. 1:30PM - I took ibuprofen. 5PM - Fever was gone, but there was headache and weakness. No sense of smell and taste. 7PM - Felt better, headache was less. little sense of smell and taste. still felt weak and dizzy. 7AM - Felt weak, dizzy. not much headache. 11:45AM - still feeling weak and dizzy.
8x10 cm red, warm area to rt upper arm @ inject site on day p/inject; react began 1st day p/w/some improvement then began spreading again on 9th day; Advil taken;
This spontaneous report as received from a pharmacist refers to a 30-year-old female patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 29-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 injection (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects reported.