chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got sick; Got / feverish; This case was reported by a consumer and described the occurrence of sickness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and fever. On an unknown date, the outcome of the sickness and fever were unknown.   It was unknown if the reporter considered the sickness and fever to be related to Shingrix.  Additional details were provided as follows: The patient's daughter called and reported the case. The age at vaccination was not reported. The patient received Shingrix and got sick and feverish. The lot number unknown to caller. The reporter did not consent to follow up.  This case linked with US2021004404 and US2021AMR005804, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021004404:Same reporter US-GLAXOSMITHKLINE-US2021AMR005804:Same reporter
chest pain; swollen; He is not working due to pain; throat scrapes; confusion; body ache; headache; fatigue; temperature; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes) and CONFUSIONAL STATE (confusion) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes), CONFUSIONAL STATE (confusion), MYALGIA (body ache), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (temperature). At the time of the report, CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes), CONFUSIONAL STATE (confusion), MYALGIA (body ache), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (temperature) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator No treatment medications provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2021-023421.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023421:1st dose
left arm and hand started tingling; Throughout the day my arm and legs kept feeling so heavy. Thankfully, the following day I felt a lot better. Even the soreness had stopped in my left arm; Throughout the day my arm and legs kept feeling so heavy. Thankfully, the following day I felt a lot better. Even the soreness had stopped in my left arm; problems breathing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 13Apr2021 at 14:00 (at the age of 63-year-old) as single dose for COVID-19 immunization. Medical history of the patient included blood pressure and asthma. Patient had no known allergies. Concomitant/other medications in two weeks included Losartan 25mg/Albuterol 90mg taken for an unspecified indication. Patient previously received Shingle vaccine in right arm on an unspecified date in Feb2021. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 14Apr2021 at 07:00, patient had problems breathing in the morning, (used Inhalant) within hour was better. On 17Apr2021, Saturday morning, left arm and hand started tingling. Patient flexed her hand and moved her arm up and down to no relief. She took half a Losartan and it stopped within an hour. Throughout the day her arm and legs kept feeling so heavy, the following day she felt a lot better. Even the soreness had stopped in her left arm. Patient received treatment in response to the events. Outcome of the event feeling heavy in arms and legs, soreness in left arm were resolved on 18Apr2021, tingling was resolved on 17Apr2021, breathing difficulty was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Myalgia, Fever, NauseaVomiting, chills Narrative: 1/20 onset of quesy stomach. 1/21 subjective mild fever, body aches, chills, and nausea. 1/22 continued nausea, mild fever, body aches, chills, but has improved energy. 1/26 - employee reports all symptoms resolved as of later in the day on 1/22.
The next day, I woke up with a splitting headache. I could hardly see. I couldn?t use my phone and had difficulty seeing in bright lights. I was overcome with chills, a fever, and a deep, throbbing ache in my lower back that continues to persist. I had to call off of work and even though I felt like I was freezing, I was sweating profusely.
This spontaneous report as received from a 74 (approximately) year old female patient regarding herself. Patient had penicillin (manufacturer unknown) allergy. Patient never had chickenpox. In 2013, the patient was vaccinated with ZOSTAVAX, 1 single shot, subcutaneously. Concomitant therapies included steroids (dosage/frequency/manufacturer unknown). Approximately in 2013, shortly after vaccination, the patient's left arm began to ache so badly in the muscle and joint that patient could hardly move it. No lab tests were performed. Unspecified gel medication was used for the treatment. The outcome of my left arm began to ache so badly in the muscle and joint that patient could hardly move it was reported as not recovered. It was reported that patient sought medical attention> The causality of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Initially I didn't have any serious side effects due to the vaccine. I felt a little sluggish the next day, but I don't even think I had a fever. But about a week later, on the next Thursday, my mom witnessed me having a seizure in my bed. I woke up incredibly sore, nauseous, throwing up, and with the worst headache I've ever had. It seems like I hit my head four times while rolling around. I went to the hospital, and they seemed to agree that I had a seizure. They ran some type of brain scan on me just to be sure I didn't have any internal bleeding, but once they realized I didn't they gave me some contact info to a neurologist and sent me on my way. I scheduled an appointment but won't get in for a few more weeks. In the meantime, I'm meeting with my general care physician today to make sure that they don't think I should do anything else in the meantime.
arm pain, painful hand numbness.   This has been going on for 6 weeks.  Most feel that a nerve was hit when I got the vaccine.  However, it got worse after the second vaccine and I know they did not hit a nerve the second time.   I have been in pain ever since I got the vaccine.  I have also hear other people have had the same issue.   Surprisingly Clariton D helps with the symptoms
Approximately 15 hours after I received my second COVID-19 vaccination I developed chills and body aches, which woke me up from sleep.  When I woke up in the morning I had extreme fatigue; even walking to the bathroom was a challenge.  I spent most of the day in bed, unable to do my normal daily activities.  These symptoms lasted approximately 18 hours then completely resolved.
PT HAD SWELLING OF INJECTION SITE, SLIGHT FEVER, NAUSEA.
Feeling under the weather; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling under the weather) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling under the weather). At the time of the report, MALAISE (Feeling under the weather) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Patient complained nausea 15 minutes after Modena Vaccine  given 2second dose Cleared by NP
This spontaneous report was received from a pharmacist who was also a patient's daughter and refers to a 70-year-old female patient. The patient's medical history included a vaccination with PREVNAR 13 on an unknown date in approximately 2015 (reported as "two years ago"). No information regarding the concomitant medications and concurrent conditions was provided. On 24-SEP-2017, at 14:30, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 injection in the left deltoid lot # N013541 with expiration date on 23-JAN-2019. It was also reported that the patient received a dose of PNEUMOVAX 23 on 17-SEP-2017, however it was not disclosed it was not reported if actual two separate doses were given on 24-SEP-2017 and 17-SEP-2017. The reporting pharmacist was also unsure if it was her mother's first dose of the vaccine. On 17-SEP-2017, half an hour after the vaccination, the patient experienced tremor and vomiting. On 24-SEP-2017, at approximately 23:30, the patient started having a "severe reaction" with extreme chills, nausea, vomiting, her arms and legs were feeling heavy and very hard to lift, but she was able to walk to the bathroom and she had a fever of 100.2 (units not provided). The patient did not have any trouble breathing or difficulty swallowing but it was hard for her to talk because of the fever and chills. She experienced normal injection site pain with no redness or inflammation and no other injection site reactions. Since symptoms started at 23:30 she had gotten better, then worse again and it had gone in a cycle. Her daughter was concerned because her mother did not usually complain at all. The pharmacist wondered if there could be something wrong with the specific batch number her mother received. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Fever 102.9 F.. Diaphoresis - confusion - abdominal pain - body aches.
Fever- Highest was 100.8, this was the following morning after receiving vaccine 1/1/2021.  Injection site was extremely sore and swollen, to the point I could not even touch the area. This was the left deltoid. Extreme fatigue, I was in bed the entire day sleeping on and off. Overall muscle pain as well.  on 1/2/2021 I was feeling much better, my arm was almost completely improved. Only mild soreness, and only a low grade temp of 99.6.  Since then, on day 5, I seem to have some dizziness but it is goes away quickly.
pt recv vax & w/in 1 to 5 mins, red hive approx 3cm in diameter @ the inj site; tx DPH @ MD ofc; VSS; w/in 20 mins sx were resolving; pt recovered same day;
Fever and chills with long period of shuddering despite being under a heated blanket.   Shaking continued uninterrupted for more than 20 minutes.  Now at1:06, no shaking but still chilled.
3-4 hours after taking the Tdap I had a fever of 103.8, I started getting migraines, and my back by my kidneys hurt extremely bad, it got worse through the night so I was admitted to Hospital. 11/5/09 DC summary and medical records received for dates 8/4/09 to 8/9/09. DC DX: Fever NOS. Present SX to ER: pt. c/o fever x3 days, chills, myalgias, low back pain, HA and photophobia. Pt. recently had puncture wound and given tetanus booster vax. Pt. states approx 6hrs after vax, developed symptoms mentioned. Pt admitted for fever. At time of DC pt stable. Pt. returned to ER for lumbar pain on 8/12/09. DX: lumbar pain, recent LP performed.
Pain near and at site of injection (left arm) for several days; flu-like symptoms for a few days; many chicken pox like sores all over body for three or four days following vaccination; hives along with itchy and burning sores for over two weeks since;  some hives and sores still developing despite steroid shot at Urgent Care on Friday, April 26.
The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023; No adverse event; Dose was given a day after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given a day after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Jan-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 (Dose was given a day after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given a day after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-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 (Dose was given a day after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023).    On 12-May-2021, patient received first dose of Moderna, Second dose of Moderna on 09-Jun-2021, Moderna (unknown whether booster or primary) on 24-May-2022.  On 06-Jan-2023, patient received moderna bivalent additional booster dose.  No concomitant medication information was provided.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The nurse confirmed that a dose was given a day after the 30-day use by date. The nurse reports that the patient didn't report adverse reaction. The nurse wants to know if the patient needs to be re-vaccinated.  The vial did not undergo any temperature excursions.  No treatment medications were provided.
*ADMINISTRATION ERROR*  48 Y/O FEMALE PATIENT RECEIVED SECOND BOOSTER (PFIZER) BEFORE 50 YEARS OF AGE, AS RECOMMENDED BY CDC.
This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 28-Jun-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2020, Pregnancy test: positive (Positive) pisitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter.
on 28jun2023 patient received a dose on menquadfi, then on 28jul2023, patient received another dose of menquadfi with no reported adverse event; Initial information was received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who received meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] on 28-Jun-2023, then on 28-Jul-2023, patient received another dose of menquadfi with no reported adverse event.  The patient's past vaccination(s) included Menquadfi in 2018. The patient's past medical history, medical treatment(s) and family history were not provided.  On 28-Jun-2023 the patient received a dose of meningococcal a-c-y-w135 (t conj) vaccine Solution for injection at dose of 0.5 ml (strength: standard, frequency: 2, lot number: U7595AA, expiration date: 11-Mar-2025) via intramuscular route in the right deltoid for Immunization (immunisation) and on 28-Jul-2023, the patient received a dose of same vaccine at dose of 0.5 ml (strength: standard, lot U7643AA, expiration date: 27-Jun-2025) via intramuscular route in the right deltoid for Immunization (immunisation) with no reported adverse event (inappropriate schedule of product administration) (latency: same day).   No lab data reported.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event on 28jun2023 patient received a dose on menquadfi, then on 28jul2023, patient received another dose of menquadfi with no reported 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 the 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.
Woke up extremely fatigued, and no appetite. Later developed chills and fever. Temp max was 100.6. Took Tylenol for fever. Slept most of day. States felt like same symptoms on day he was admitted to hospital when he had covid except no shortness of breath.  Next day on 1-21-21, he continued with exhaustion, being cold and nausea.
cold sores; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd March 2020, 9 days after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and around March 3 or 4, developed cold sores.  She has not had cold sores for years. The reporter did not consent to follow up.
Headache, nausea, dizziness and joint pain that started about noon 1/20/21.  Took some Advil and laid down,  headache has resolved, not feeling nauseous but still having joint pain in hands with stiffness, knuckles, and knee  pain and hips.
Rash started two days after the vaccination on 10/02/2019. on chest, front of body and upper legs and thighs. was  very itchy but not painful. rash was external. rash lasted for 5-6 days.  pt reported rash to her md at refular scheduled appointment who said he was not familiar with rash as a side effect. she reported rash to pharmacy when she went for her second dose.
1-31-20 - RASH APPEARS ON UPPER BACK - SPREADS TO ALL BACK DOWN TO BUTTOX - FEB 11th - BEGAN CLOBATASOL (STEROID CREAM) - COUPLE DAYS RASH APPEARS ON CHEST FRONT + SIDES, BACK OF NECK AND ALL OF SCALP - Rx WON'T KEEP UP W/SPREAD NOW ON INSIDE THIGHS - ARMS & BACK OF HANDS RED RAISED SPOTS + WELTS - VERY ITCHY!! HORRIBLE & BLOTCHES ALL OVER (NOT HIVES) SO FAR CANNOT FIND APPROPRIATE TREATMENT TO STOP IT I USE CERAVE ITCH RELIEF CREAM 2x DAILY - HELPS A LITTLE! I'M VERY UPSET! - AFTER ONLINE RESEARCH, DID NOT SEE THIS AS SIDE EFFECT! BEFORE GETTING THE SHOT! SEE ONLINE SITE (OTHERS W/SIMILAR RASHES) SHINGRIX REVIEWS & RATINGS WEBSITE - SCROLL DN, READ ABOUT RASHES AFTER 4 DAYS OF SHOT! THERE ARE SEVERAL - DERMATOLOGIST DESCRIBED AS "DERMAL HYPERSENSITIVITY SYNDROM" SAID SHINGLES SHOT CAUSED IMMUNE SYSTEM TO OVER REACT?? I'VE HAD THIS FOR SIX WEEKS & COUNTING, CONTINUES TO GET WORSE
Child was given wrong prevnar- office manager spoke to mom and as of 3/21/23 330pm no reaction has occurred. Child was happy and doing ok.
Narrative:  COVID infection following COVID vaccine series 02/02, Pfizer, dose #1 outside LOCAL PHARM 03/02, Pfizer, dose #2 outside LOCAL PHARM 04/10 COVID swab, result NOT detected 10/18 COVID swab, result: detected 10/20 pt cc: exposure: unknown
Seen 7/12/16 at family practice. Pt received Varicella 7-8-16 in R arm. The next morning she noted redness, warmth, edema at site. She called office on 7-9-16 and reported she was applying ice and utilizing ALEVE. Family practice concurred and pt instructed office visit if not improved.
Severe shoulder joint pain occurred 12 hours after infection, with locked joints lasting up to 36 hours after injection.  Since injection, shoulder pain and inflammation has persisted.  Each dose was given in opposite arms, and both shoulders are experiencing pain.
He got the hep b vaccine at the hospital the day he was born, the side effects started 7 days later: seizures, but other side effects started to be shown during his fist 3 years of life: allergies, speech delay, gross and fine motor delay. We have stopped vaccination recently.
L/arm started swelling about noon on 11/11/99. Mother called PMD & was advised to alternate heat & cold to site, give Tylenol & Benadryl. Temp 99.9 AX at 8:00 pm. Arm much better today, red area measured 3
pt recv vax & the next day devel bloody mucus-containing stools;A GI workup was performed which was negative; Follow-up informaiton was received 1/17/97. On 8/1/96, this infant received his second dose of ORIMUNE and ACT-Hib (Connaught). On 9/19/96, he developed bloody, mucus containing stools. He was seen by a gatroenterologist and underwent sigmoidoscopy with biopsy. The gastroenterologist diagnosed bening nodular lymphoid hypeplasia of the left colon, sigmoid, and rectum, as well aa anal cryptitis. The gastroenterologogist and an infectiious diseae specialist have stated that "it is not possible" for this event to have been caused by Orimune. The diarrhea peristed at the date of follow-up.