chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states right arm pain started about 5 day ago. Explained his pain as soreness when lifting his arm, limiting his mobility of the right arm. Skin on the right deltoid area does not show any redness or swelling. Bandaid from vaccine injection site was still present and measures 4 fingers below the shoulder joint. I did lift the bandaid to inspect the injection site, again no redness, swelling, or drainage is noted. States he has been taking tylenol to treat the pain and feels the pain is increasing. He was advised to contact PCP for further evaluation.
round red itchy circle; round red itchy circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (round red itchy circle) and VACCINATION SITE ERYTHEMA (round red itchy circle) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (round red itchy circle) and VACCINATION SITE ERYTHEMA (round red itchy circle). At the time of the report, VACCINATION SITE PRURITUS (round red itchy circle) and VACCINATION SITE ERYTHEMA (round red itchy circle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sudden deafness in left ear occurring 10/29/2021.  Treated with Prednisone for 3 weeks.  No recovery.  Cochlear implant surgery 4/6/2022.
Hives developed on inner right thigh within 5 minutes of vaccine administration and spread to abdomen and face within 10 minutes. Benadryl 8 mg orally was given
Pale, limp episode of 10 second duration; Responded to shaking; Hospitalized; Upon exam also noted to have UTI; No past problems w/vax; No known allergies;
Flu like symptoms; Dizziness; Nausea; Pain in her joints; Chills, but no fever; Soreness in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (Dizziness), NAUSEA (Nausea) and ARTHRALGIA (pain in her joints) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm). On 02-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (Dizziness), NAUSEA (Nausea), ARTHRALGIA (pain in her joints) and CHILLS (chills, but no fever). In October 2021, PAIN IN EXTREMITY (soreness in her left arm) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (Dizziness), NAUSEA (Nausea), ARTHRALGIA (pain in her joints) and CHILLS (chills, but no fever) outcome was unknown.            No concomitant medications were reported  No treatment information was provided
Information has been received from a physician concerning a child who a year or so ago was vaccinated with a dose varicella virus vaccine live. The physician reported that in June 2005, the patient developed chickenpox. Unspecified medical attention was sought and at the time of this report the patient was noted to be recovering from the chickenpox. Additional information has been requested.
Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 001C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) from 02-Dec-2020 to an unknown date for Substance use disorder.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-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 PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Patient demographics was updated. Suspect product dose 1 details was added. Dose 2 information of anatomical location was updated. Concomitant medication-Suboxone was added.
Pt developed redness around the injection site in the evining after administration.  Over the next day, it was warm and hardened slightly.  Mother drew a line around the area, by the next day, it had spread past that marking so she brought him in to be seen.
Inflammation of gums  causing pain and impacting ability to eat/chew. Waiting to consult with a periodontist.  Symptoms have worsened in the 8 days post-vaccination  Fever/chills - resolved  Significant fatigue - persists
Bed chilling; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Bed chilling) 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 22-Feb-2021, the patient experienced CHILLS (Bed chilling). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Chills, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (Bed chilling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included Motrin and Tylenol.   This case was linked to MOD-2021-024573, MOD-2021-024583 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-024573:Same reporter MOD-2021-024583:Same reporter
One hour after vaccination started to run fever had body aches and chills along with headache. These lasted for 4 days. On the 5th day flu like symptoms faded but all she wanted to do was sleep. No appetite. She is 10 days out and is still very sleepy and does not feel like doing anything. The headache has not completely  subsided. I advised her to call her Dr.
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified numbers of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018).   In APR-2023, the patients received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 The patients were over 50 year of age. The health care professional (HCP) mentioned the pronome "they" several times, so it is possible that there is more than one patient on this situation but this could not be clarified. The HCP declined to provided information for Safety.  Follow up (FU) could not be requested as well as permission to create HCP´s account on Medical Information database.       The reporter did not consent to follow-up. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Headache, Myalgia, CoughWheeze, NauseaVomiting, Syncope, clammy, sweaty, flushed, fatigue Narrative: Reports shallow breathing as well as other symptoms mentioned. First dose symptoms lasted 7 days and second dose symptoms lasted 5 days. Never tested positive for COVID but she things may have had a possible infection in Jan 2020. Reports history of allergies.
Within 5 minutes after administration completed of all 5 vaccines. Patient became lethargic, remarkable redness and swelling of injection sites on both legs, remarkable blotchiness of entire upper leg and scattered on torso. Upon immediate okay by myself and doctor. No respiratory distress/ B>E and clear given Zyretec syrup 2.5mg after 30-45 minutes. Reactions has resolved. Patient to be evaluated by pediatric allergist after administration of any shots.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 02-MAR-2015, the patient was vaccinated with RECOMBIVAX HB 2.5 microgram/0.5 ml (dose, route of administration, anatomical location and lot number was unspecified by reporter) which was expired on 07-FEB-2015. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No additional information was provided. Additional information has been requested.
L1 Zoster, vesicular, lasted 10 days.PCR (+) for vaccine strain
Lost my appetite/doesn't eat as well as he use to; Everything went to crap; lot of tiredness; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost my appetite/doesn't eat as well as he use to), MOOD ALTERED (Everything went to crap), FATIGUE (lot of tiredness) and HEADACHE (severe headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METOPROLOL and AMLODIPINE for Blood pressure management.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DECREASED APPETITE (Lost my appetite/doesn't eat as well as he use to). 01-Apr-2021, the patient experienced MOOD ALTERED (Everything went to crap), FATIGUE (lot of tiredness) and HEADACHE (severe headaches). At the time of the report, DECREASED APPETITE (Lost my appetite/doesn't eat as well as he use to), MOOD ALTERED (Everything went to crap), FATIGUE (lot of tiredness) and HEADACHE (severe headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   This case was linked to MOD-2021-230194, MOD-2021-230194 (Patient Link).
Pt. states that after receiving the 3rd dose of Booster Phizer 10/05/2021, started experiencing symptoms 10/06/2021 of chills, body aches, fatigue, headaches, and muscle aches. Self-treating with Tylenol and improving. No noted Primary visit.
experienced dyspnea, diarrhea, nausea, vomiting Associated with a long term care facility
mild-moderate erythema of lt deltoid area puffy lt shoulder although normal ROM;warm to touch;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at an Urgent Care for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient called the pharmacy after receiving these 2 vaccines to state he had already received 2 shingrix doses and we just administered a 3rd. Upon review it was discovered his 2nd shingrix dose on 11-17-20 was not put in our state reporting database WIR. Upon review of pharmacy records it was discovered patient had received Shingrix on 9-18-20, 11-17-20 and 08-10-21
SEIZURES LEFT LEG AND LEFT CORE, TEN EPISODES SINCE 03/14/2021
3 days later after the vaccine, all of the sudden I got a call and I normally answer with my left hand on my left ear and I heard a lot of static so I moved it to the right ear and again, I heard static and that is when it hit me that it wasn't the phone. It was my ear. I did not have any pain or nothing, just static on both ears. I cannot hear people over the phone. Also, when I have my family talking or even the TV I hear like an echo and static, It's a weird thing. On 12/19/2021 I went to see Doctor and I was given steroid, 3 weeks after that I was given a MRI and he couldn't find anything, No tumor no nothing. Everything looked good.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis). On an unspecified date (reported as subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Pt immun 5Mar91.Evening of 6Mar91,mom states pt lt deltoid edematous, inject site pink & tender.7Mar91 mom noted lt deltoid erythematous,painful to touch& move,edematous. Pt arm had red streak from deltoid-Dx = cellulitis.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt like I got hit by a freight train), FEELING ABNORMAL (brain fog), GAIT DISTURBANCE (couldn't walk very well), ASTHENIA (weakness) and MYALGIA (a lot of body aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE (felt like I got hit by a freight train), FEELING ABNORMAL (brain fog), GAIT DISTURBANCE (couldn't walk very well), ASTHENIA (weakness), MYALGIA (a lot of body aches), HEADACHE (intense headache) and PYREXIA (101.7 fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, MALAISE (felt like I got hit by a freight train), FEELING ABNORMAL (brain fog), GAIT DISTURBANCE (couldn't walk very well), ASTHENIA (weakness), MYALGIA (a lot of body aches), HEADACHE (intense headache) and PYREXIA (101.7 fever) had resolved. No concomitant medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Initial additional information included updated email id of primary reporter.
~10 hours after shot, fever/aches/chills. These resolved within 24 hours  Had headache for around a week.  Skin on the roof of my mouth peeled off around 5 days after the shot. Very uncomfortable.  Swollen lymph nodes in neck and general sort of occasional light-headedness for around 1 month post-shot.
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Initial additional: first dose date, event onset date and reporter (consumer) causality updated.
1/9/09 0830 Pt. called to report that she had a rapid heart rate which started approximately 1/2 hr after receiving the vaccine and lasted for approximately 2hrs. Around 7pm that evening she felt nauseated and felt itchy on her face and arms. The vaccination site became red and itchy with 2 red areas about the diameter of a half dollar. She feels better today 1/9/09 but still feels itchy on her arms and face with a little nausea. Advised her to contact her PMD.
tingly feeling; my arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingly feeling) and PAIN IN EXTREMITY (my arm is really sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-May-2021, the patient experienced PARAESTHESIA (tingly feeling) and PAIN IN EXTREMITY (my arm is really sore). At the time of the report, PARAESTHESIA (tingly feeling) and PAIN IN EXTREMITY (my arm is really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
hosp 03aug96 to 05aug96 w/ fever 104 degrees; spoke w/ Dr's office; Dx: tonsillitis
Depression/Depression lessened before the second shot.; Brain fog presented; The patient brain fog contributed to a car accident.; This is a spontaneous report from a non-contactable consumer. This 38-year-old consumer (patient) of unknown gender communicated to a Pfizer sales representative that he/she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date after the first shot the patient presented depression and brain fog. The patient's brain fog contributed to a car accident. It was mentioned that depression lessened before the second shot. The outcome of depression was recovering, the outcome of brain fog and car accident was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Pain in arm I received vaccine. Arm felt sore for about 2 days.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the arm on 25Mar2021 at 11:00 (at the age of 44-years-old) as a single dose for Covid-19 immunisation.  Medical history and concomitant medication  was reported as no. The patient was allergic to peanuts.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19.The patient experienced pain in vaccinated arm  on 25Mar2021, and arm felt sore for about 2 days. The patient had not received any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the pain in arm was resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and injection site tenderness. On an unknown date, the outcome of the pain in arm and injection site tenderness were recovering/resolving. It was unknown if the reporter considered the pain in arm and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient stated that he had tenderness at the injection site, and the entire arm was sore. The patient was 80 percent better at the time of reporting. The patient had denied permission to contact their physician. No further details were provided.