chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness around injection site; Redness was warm to touch; Tenderness; A spontaneous report  was received from a Consumer concerning a 76 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, redness around injection site, redness was warm to touch, tenderness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced the events, redness around injection site. redness was warm to touch, tenderness. Treatment details included None Action taken with mRNA-1273 in response to the events, redness around injection site, redness was warm to touch, tenderness was not reported.   On an unknown date the outcome of events include, redness around injection site, redness was warm to touch, tenderness was not reported.  Based on comment, (redness around injection site) causality assessment is missing. Possibly related would likely be entered in this field
Vertigo/similar symptoms after both the doses; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo/similar symptoms after both the doses) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Nov-2020 and Pneumonia (She was hospitalized in ICU step down had double pneumonia.) on 14-Nov-2020. Concurrent medical conditions included Atrial fibrillation. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy, PARACETAMOL (TYLENOL EXTRA STRENGTH) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 08-Apr-2021, the patient experienced VERTIGO (Vertigo/similar symptoms after both the doses). The patient was treated with MECLIZINE HCL for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo/similar symptoms after both the doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-080242, US-MODERNATX, INC.-MOD-2021-080194 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080194:cross linked case
Patient administered first dose of the Moderna COVID-19 vaccine at age of 13; This spontaneous case was reported by a dentist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13). On 30-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-271958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up received on 20-Sep-2021 contains no new information , but action taken updated to not applicable single event of medication error reported.
She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of IRON DEFICIENCY ANAEMIA (She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IRON DEFICIENCY ANAEMIA (She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose). At the time of the report, IRON DEFICIENCY ANAEMIA (She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Haemoglobin: 6 (Low) iron deficiency anemia with hemoglobin of 6 percentage.         No concomitant medications were reported. It was reported that the patient was diagnosed with iron deficiency anemia and a hemoglobin of  6  percentage about 5 weeks after she received the booster dose. Patient was taking unspecified anemia medication.
Sore arm, red to elbow and under arm near breast on left side, purple and very painful. Pt went to hospital, had x-rays, lymphadenophy. Hospital. Sent to pcp.
Employee reports approx. 20 - 30 minutes post vaccination and states "I feel like I'm high". "When I walk I feel like I'm gonna fall". "It is not my same breathing" and the back of my head and left eye feel like they are going to hurt per employee.
TOOK VIVOTIF ON CONSECUTIVE DAYS INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-2145) was received from a consumer on 21-Aug-2019. It described a 65-year-old elderly female consumer who "took Vivotif on consecutive days instead of every other day" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid prophylaxis.  Case report: The consumer completed full course of Vivotif about 2 weeks ago, but she took all the doses on consecutive days instead of every other day.   Action taken with Vivotif was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.
Information has been received from a health professional concerning a 16 year old white female student (142 lbs., 61.25 in.) who on 19-FEB-2007 was vaccinated with Gardasil. The patient was vaccinated with the second dose of Gardasil on 19-MAR-2007, which was only one month post dose one. The patient had no illness on the day of vaccine administration. On 22-MAR-2007 the patient experienced symptoms of hives and feeling dizzy and sought unspecified medical attention. No laboratory/diagnostic tests were performed. Subsequently, the patient recovered from symptoms of hives and feeling dizzy. Additional information is  expected.
client was given his first vaccine on 6/23/2021 and it was a Pfizer vaccine.  He was accidently given his second vaccine shot on 7/29/2021 of Moderna
I had pain in my ear.  Went to MD.  Dx with fugal infection.  Hearing then  decreased?went to audiologist for follow up- had more hearing loss,     Not sure if related but CDC called me and asked me to fill out form
large red rash/swelling/itching/hot & was a hard ball where it was given;d/t 5/8" needle provided by Wyeth this inj probably went SC;
I got a bursting sound in my hear; it stops and sometimes it is very loud and sometimes it very low; get a buzz ears like 17-year locust; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6208) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "Bone marrow cancer" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for atrial fibrillation; ACYCLOVIR [ACICLOVIR]; MONTELUKAST; DEXAMETHASON [DEXAMETHASONE]; DEXTROTHYROXINE taken for thyroid disorder. Vaccination history included: Bnt162b2 (Dose 1, Lot number: unknown), for Covid-19 immunization. The following information was reported: HYPERACUSIS (non-serious), outcome "unknown", described as "I got a bursting sound in my hear; it stops and sometimes it is very loud and sometimes it very low"; TINNITUS (non-serious), outcome "unknown", described as "get a buzz ears like 17-year locust". Therapeutic measures were not taken as a result of hyperacusis, tinnitus.  Additional information: Patient had second Pfizer shot on Friday and all over sudden yesterday patient got a bursting sound in my hear actually on Friday night. It was constant sound and it go to the different level of volume. And it casually it stops and sometimes it was very loud and sometimes it was very low. It was kind of like, patient don't know can hear some buzzing sound, it was really loud like that and other time it sounds like a very hard stemmer. Patient was concerned about this as one of the side effects or could be because that's the only thing was difficult in life right now. Patient was trying to find out that could be the cause of the sudden change." Start date: Consumer stated, "On Friday at about 4:40." Reportedly, patient had second shot of Pfizer on Friday around 12:30 and all of a sudden that night patient started to get a buzz ears-familiar with 17-year locust but it said 'hmmmm' sound and something and then it goes sometimes sounding like a very hot steamer with the steam coming out and it can be at different volumes at a very short period time when patient didn't had it at all and that's the only thing that has been different in her life and patient don't know what has caused that and it's not a ringing in the ears it's quite a different sound and maybe it's related to the vaccination and it may not be but patient don't know exactly what to do about it." Treatment: "No, haven't because it was weekend and doctors are not super available here." Lab test: Consumer stated, "Yes, have warfarin level, what is it 'IRN' or something I don't know what it is."  No follow-up attempts are possible. No further information is expected.
11 year-old female received 6th dose of Daptacel; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA151476 (same reporter).  This case involves an 11 years old female patient who experienced received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation received on 24-May-2019 in the left deltoid.  On 24-May-2019, the patient received a single 0.5 ml 6th dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via unknown route in the right deltoid.  It was of actual medication error due to extra dose administered.  It was unknown whether adverse event occurred.  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.  List of documents held by sender: none.
chills and uncontrollable shakes, no fever initially; within a few hours temp was 101.6; cultures and labs showed urinary tract infection; sensitivities showed resistant to rocephin and ceftin; bactrim didn't prove strong enough; improvement finally began with levaquin; fever persisted 8 days; ibuprofen was required around the clock
left arm pit area started hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm pit area started hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced VACCINATION SITE PAIN (left arm pit area started hurting). At the time of the report, VACCINATION SITE PAIN (left arm pit area started hurting) outcome was unknown.      No concomitant information was reported. No treatment information was reported.
Shingles diagnosed by Primary Care doctor on August 17. Right side of my body hurts (right arm & upper part of the right side of my back). Rash started on my breast and upper back. Rash keeps expanding. This is the first time in my life I have ever had Shingles. Prescribed Valacyclovir and Gabapentin. This happened after my first shot of Moderna.   I also had body aches, temperature of 100.6, nauseous, dizzy and couldn't get out of bed the day after my first Moderna shot.
Normally had mild, manageable tinnitus in both ears 24/7. However, after this shot, the volume has exploded to 2-3 times what it used to sound like. It first became loud about 30 minutes after the shot, then became better the next day, then became loud again, and has persisted for the past 2 weeks. I am trying to deal with it mentally but sometimes I am just barely holding down anxiety attacks.
Moderna 3/11 and 4/8. Positive on 9/5 admitted 9/5 to current
I did not have an adverse reaction to the vaccine. I began not feeling well on 04/04/2023 with head and chest congestion, sneezing and runny nose. I tested positive for COVID-19 on 04/06/2023. I contacted my doctor and got a prescription for PAXLOVID. I tolerated the medication, but the taste was terrible. As of today, I have a little congestion, but it could be due to seasonal allergies.
Hives left deltoid which started at injection site an hour after given- spread to entire leg arm, swelling- Mom gave BENADRYL 50mg at onset and for 24hrs after - Self resolved.
inadvertently administered the Shingrix Diluent only without the Lyophilized powder; inadvertently administered the Shingrix Diluent only without the Lyophilized powder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 42KG3, expiry date 15-AUG-2025) for prophylaxis.   On 01-AUG-2023, the patient received the 1st dose of Shingrix. On 01-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Shingrix Diluent only without the Lyophilized powder) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Shingrix Diluent only without the Lyophilized powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 02-AUG-2023 The pharmacist  called to inquire that if any information available? What to look for? The reporter did not consent to follow-up. The patient was inadvertently administered the Shingrix diluent only without the lyophilized powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Extremely painful dark pink area approximately 9 cm x 5 cm. Any contact while in bed awakened me and elicited screams.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 20-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot # N013277, expiration date: 28-APR-2019 (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA002990: US-009507513-1805USA003480: US-009507513-1805USA003482: US-009507513-1805USA003483: US-009507513-1805USA003484.
Moderna booster dose was administered to a 16 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose was administered to a 16 year old) in a 16-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose was administered to a 16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose was administered to a 16 year old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that a Moderna booster dose was administered to a 16 year old.  Treatment information was not reported.
I started having chest pain the day after the shot was administered. It got steadily worse, and I went to the ER 4 days later. They did a chest xray and bloodwork and nothing urgent was happening, so sent me with instructions to follow up with my primary care doctor. Did a video chat with primary care doctor, she advised 800mg ibuprofen 3x/day for a week, and to call back if I was not better. After a week I was not better, I was worse (it now hurt severely when I bent forward, and all the time I had chest pain, and when I walked my dog I could feel my heart faltering. It was so scary.) So I went in to the see the doctor and she prescribed colchicine and indomethacin and an urgent referral to a cardiologist.
Body itchiness within a few hours, then nausea and chills by hour 9, then fever, fatigue, body aches, joint pain. Fever unresponsive to Tylenol. Constipation, then diarrhea on day 3. Day 3 felt fine. Then Day 4 got all respiratory and heart symptoms; tight chest, shortness of breath, chest pain, bronchial cough
administered after frozen,  0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 7-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 reporter stated that, FluLaval administered after frozen at temperature of minus 0.45 degree C, which led to incorrect product storage. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230177:Same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter
1 day p/vax pt exp rash, red & swollen arm, & h/a; treated w/Darvocet;
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves three patients (with unknown demographic) who received a dose of PENTACEL and MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. Three patients received invalid doses of MENACTRA and PENTACEL due to a temperature excursion for 48 hours. It was unknown whether the patients had any adverse reactions. 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. List of documents held by sender: none.
Hypertensive episode with tachycardia, chest pain, dizziness. 2 episodes within 30 minutes. Patient did not eat or drink today. Observed for 45 minutes - given food and drink. Felt fine.
On 62520 pt c/o discomfort at the site and by evening  he had a welt/redness down his arm 7" x 4".  Televisit done on 06-26-2020 per mom feels warm, mild tender w/palpation, no hematoma palpated - believed to be predominantly localized reaction but treated empirically with Augmentin 875-125 mg tablets, 1 tablet orally BID for 10 days.  Next day site was even larger and he had a headache
When our facility received the Covid - 19 vaccine, I spoke to a health professional and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 Health Professional Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus, we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.