chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hurting; discomfort; is concerned; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurting), DISCOMFORT (discomfort) and ANXIETY (is concerned) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (hurting), DISCOMFORT (discomfort) and ANXIETY (is concerned). At the time of the report, PAIN (hurting), DISCOMFORT (discomfort) and ANXIETY (is concerned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given. Treatment information not provided.
headache; spinal pain and pressure; numbness in hands and feet; spinal inflammation; missed her second dose; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 23Dec2020 as single dose for COVID-19 immunization. Medical history included COVID-19 tested positive on 12Dec2020. The patient's concomitant medications were not reported. The patient received first dose while still battling Covid-19 symptoms. On an unspecified date after the vaccination, the patient experienced headache, spinal pain and pressure, numbness in hands and feet, spinal inflammation. The clinical course included: when the Pfizer Covid vaccine became available at her hospital, she received the 1st dose of Pfizer Covid vaccine on 23Dec2020 but was still battling Covid-19 symptoms. Caller stated that days after receiving the 1st dose of the vaccine she began to have severe symptoms which included, headaches, spinal pain and pressure, numbness in hands and feet. After vaccination, the patient also had bad over immune response where there was spinal inflammation and missed her second dose. She was seen by neurology, and other specialist, which at that time advised her not to proceed with taking the second dose of the Pfizer Covid vaccine. Caller has been recovered and wanted to know if she can go ahead and take the second dose of the Pfizer Covid vaccine now or do need to start the series over. The clinical outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Fell so tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fell so tired) 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 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 FATIGUE (Fell so tired). At the time of the report, FATIGUE (Fell so tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Death Nos; Suspected vaccination failure; Shingles, treated w/remdesivir, died in 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included remdesivir for product used for unknown indication.   On an unknown date, the patient received Shingles vaccine and remdesivir at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with remdesivir was unknown. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure and shingles were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shot and got shingles 2 times after that. The reporter did not trust the Covid vaccine as the patient passed away last year from the remdesivir they treated and died in 4 days. It was unknown if the reporter considered the death nos, shingles to be related to remdesivir. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2023AMR023214 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR023214:Same reporter; Reported Cause(s) of Death: Death NOS
The day after I received the second dose, I experienced arthralgia, chills, fever, and muscle aches. The second day after the vaccine, those symptoms were much relieved.
Some of the vaccine leaked out as she administered a customer's 1st dose; A spontaneous report  was received from a pharmacist concerning a male patient who had some of the vaccine leaked out as she administered a customer's 1st dose (accidental under dose).  Patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot/batch: unknown) for prophylaxis of COVID-19 infection.  Some of the vaccine leaked out as she administered a customer1s first dose (accidental under dose).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event Some of the vaccine leaked out as she administered a customer1s first dose (accidental under dose) was considered resolved.; Reporter's Comments: This case concerns a male patient of unknow age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting accidental under dose without any associated adverse events.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID19 resulting in Hospitalization/ Death Patient received Pfizer Vaccines on 4/14/2021 and 5/5/2021. Patient presented to ED on 8/8/2021 with symptom onset 8/6/2021 of SOB, Cough, Fever, Body Aches, diagnosed with COVID-19 and pneumonia.  Patient expired on 8/14/2021.
Patient seen for left shoulder pain/bursitis x 2 months. Placed on pains meds (ibuprofen, Acetaminophen) and PT consult.
Stomach Flu; Vomiting and Diarrhea; scary and weird; Woke up very sick; Entire body ache; Vomiting and Diarrhea; Rash and boil on knees and fore arm; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (Stomach Flu), DIARRHOEA (Vomiting and Diarrhea), FEELING ABNORMAL (scary and weird), ILLNESS (Woke up very sick) and RASH (Rash and boil on knees and fore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included THYROID (LEVOTHYROXINE AND LIOTHYRONINE [THYROID]) for Thyroid disorder, MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced RASH (Rash and boil on knees and fore arm). On 12-May-2021, the patient experienced GASTROENTERITIS VIRAL (Stomach Flu), DIARRHOEA (Vomiting and Diarrhea), FEELING ABNORMAL (scary and weird), ILLNESS (Woke up very sick), MYALGIA (Entire body ache) and VOMITING (Vomiting and Diarrhea). At the time of the report, GASTROENTERITIS VIRAL (Stomach Flu), DIARRHOEA (Vomiting and Diarrhea), FEELING ABNORMAL (scary and weird), ILLNESS (Woke up very sick), RASH (Rash and boil on knees and fore arm), MYALGIA (Entire body ache) and VOMITING (Vomiting and Diarrhea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: (Positive) Positive. On an unknown date, Blood immunoglobulin M: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided
w/in 48hr of vax mom reported episodes of involuntary muscular contractions which were proven by EEG to be infantile spasms;adm to hosp & begun on ACTH;
acute kidney injury, ischemic cardiomyopathy, hypotension due to hypovolemia.  Seen in the emergency room then transferred to another hospital.
Information has been received from a physician concerning a 13 week old female patient who on 21-JUL-2008 was vaccinated orally with a first dose of ROTATEQ vaccine live (human-bovine). There were no adverse effects reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Given Tdap (ADACEL) on 9-30-14 at 11:20 am. Swelling dark pink to red skin color change. Warm to touch.
I received my first Moderna vaccine on one/14/21, the second on 2/11/21, booster on 1/12/22. I work in public health and was on the front lines of treatment for this pandemic. I experienced significant lower extremity lymphatic swelling with each injection, the most significant of which occurred with the second injection in the right groin. The significant swelling of the lymph nodes lasted for about a week with each event. I also completely quit having a menstrual cycle and it has not returned. I was menstruating normally prior to the vaccine and no history of gynecological abnormalities. I also suffered severe full body joint pain but again more significant in my lower extremities. I continue to have persistent and severe right hip, right SI joint and right pelvic pain since the injection. I have struggled with abrupt onset of menopausal symptoms which I directly attribute to the vaccine and have abnormalities detected in my ovaries and uterus which are under further investigation.
This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On 14th June 2018, 7 days after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The age group was not reported but was selected as adult as per vaccine indication. A week after receiving SHINGRIX, the patient experienced the reaction. The reporter was wondering about reactions to SHINGRIX vaccine. No additional information could be obtained. The healthcare professional ended the chat.
pt recvd vax; exp fever, malasia x 2 days; feeling better now;
A non-serious spontaneous report of bronchitis and pneumonia was received from a parent concerning a four-year-old male.  The child's medical history included cold, seasonal allergy, postnasal drip, atopic, and peanut allergy.  No concomitant medication was reported.  The patient received FluMist on 03Nov2007.  On 07Nov2007, a parent reported that her son was diagnosed with "bronchitis/early pneumonia" four days following Flumist vaccination.  The child had sniffles the day of vaccination.  The mother states that it was difficult to tease apart her son's colds from his seasonal allergies and postnasal drips.  The child was started on a Z-pack.  The patient was recovering.  The causality was not reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Couple hours after vaccination reported extreme fatigue, muscle aches and pains throughout entire body. Reported having for 2 days and unable to get out of bed.
PT RECEIVED MODERNA #1 ON 3/26 AND PASSED AWAY ON 3/28 AT HOME.
pain at injection site, swelling of left arm, redness at  site of injection, and swollen lymph nodes Narrative:  Other Relevant History:
This spontaneous report as received from a 53 year old female patient reporting on herself. The patient's pertinent medical history was not provided. The patient had no known drug reactions/allergies. On 30-JUL-2014, the patient received one dose of ZOSTAVAX, (Lot # reported as K-000328, expiration date reported as 06-MAR-2015). Co-suspect therapy and concomitant medications were not provided. The patient reported that on 01-AUG-2014 at 04:00 AM, the patient woke up with a burning, painful dark pink egg-sized knot at the injection site after getting ZOSTAVAX two days ago. The reporter added that the site itched a little and felt hot. The patient did not receive any treatment for the event and sought medical attention by calling the pharmacy. At the time of the report the patient had not recovered. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
I developed a Urinary Tract Infection approximately 3 days after the vaccine. (This was the 2nd vaccine.)  This was very unusual.  I estimate that I haven't had a UTI for about 15 years.  The exception was that I got one after the 1st vaccine.  I reported this separately (see confirmation # 584913.)
FLU SYMPTOMS; UPSET STOMACH; HEADACHES; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Vaccinated at the right arm. No concomitant medications were reported. On an unspecified date, the subject experienced flu symptoms, upset stomach, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu symptoms, headaches and upset stomach was not reported. This report was non-serious.
Symptoms: light-headed and anxious / cold & dizzy Intervention/treatment: assess vital signs, apple juice, granola bar/ fruit leather Vitals: BP 115/58, RR 18, Pulse 68, O2 100%
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021 at 10:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Patient received the booster dose, where error dose administered with expired vials. although there was no adverse event reported.  later the facility requested the patient to receive re-dose of Moderna with an unexpired vials.
After returning from trip on 7/7/2022, I was exposed to covid after being packed is customs hall for about 2 hours with about 200 mostly mask-less people. Unsurprisingly, I came down with covid despite having had both boosters. I was prescribed Paxlovid by an after hours clinic doctor.  My symptoms were only a fever of 101 for about 1 day and exhaustion.  By then end of the treatment course, I seemed to be cured except for continuing feeling of exhaustion, but a covid rapid test came showed negative..  Then after 2 days mild symptoms of congestion and more pronounced exhaustion came back and I tested strongly positive for covid again.  After another day or so, I then developed thrush, or covid  tongue.  I was prescribed medication for that which worked after several days. One week after the positive test, I again tested negative.  Fatigue continued for another several weeks.
1st dose in 2018, 2nd on 25Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number B97G2, expiry date 26th January 2024) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   On 25th November 2022, the patient received the 2nd dose of Shingrix. On 25th November 2022, 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 Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The reporter asked if the patient needs a third dose of Shingrix. The lot number and expiration date correspond to the second dose administered. The reporter consented to follow-up. Additional supportive information: The patient received second dose of Shingrix, which led to lengthening of vaccine schedule.
Punctate Keratitis Both Eyes: associated with light sensitivity, blurred vision, and tearing
12 hrs after vaccine: fever 100, HA, sore throat, stomach ache.
High fever, high pitched screaming for 4+ hours, refusal to eat for 7+ hours, no wet/dirty diapers
does not remember a thing; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (does not remember a thing) and COVID-19 (tested positive for COVID-19) 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 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (does not remember a thing) (seriousness criterion hospitalization) and COVID-19 (tested positive for COVID-19) (seriousness criterion hospitalization). At the time of the report, MEMORY IMPAIRMENT (does not remember a thing) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO Concomitant medication was reported NO treatment Drug was reported  On 27Aug2021 the patient was in hospital until recently (about a month ) and tested positive for COVID-19   company comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of COVID-19 and Memory impairment. The events occurred after the first dose of Moderna Covid-19 vaccine. Hospitalization was on 27-AUG-2021 for a month and the patient tested positive for Covid-19. The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since the events occurred only after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of COVID-19 and Memory impairment. The events occurred after the first dose of Moderna Covid-19 vaccine. Hospitalization was on 27-AUG-2021 for a month and the patient tested positive for Covid-19. The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since the events occurred only after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.
Pt c/o pain, swelling, redness to right deltoid. No exudate.  Dx: cellulitis
Vaccine given in the afternoon of 1/16, a Saturday.  By Sunday am on the 17th, the hearing was gone in my right ear.  Got into the ENT doctor on Monday the 18th.  Had an exam and hearing test. Started high dose of steroids on 1/19. Had to be out of work for 1 month.  About 80% ish of the hearing returned in that ear. Had 1 steroid injection into ear drum of that ear.  Throughout the month, had many ENT appointments and hearing tests. Hyperbaric chamber was recommended by the dr. But my insurance would not cover it.
Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), via an unspecified route of administration on 15Jan2021 08:00 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin.  The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced nausea, injection site bruising and pain at 15Jan2021 09:00AM. No prior covid vaccination. No Covid tested post vaccination. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Events resulted in none of the above. Patient was recovered in 2021. No treatment received for adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182443 same reporter, same patient, same product (different dose), different events
Weird, bad feeling at first followed by bad aching , joint pain, headache, shoulder pain, neck pain , back pain.
About 9 days after receiving my first vaccine, I became very weak and fatigued.  I slept most of the days from 9/10-9/12. During that time, I experienced panic attacks, my lymph nodes in my neck and throat begin to swell and became painful. On 9/13 I attempted to start my shift at work but by 10:30am I was in the ER. Antibiotics were given due to my lymph nodes being enlarged.
The night I received the first Moderna vaccine I had a low-grade fever with muscle aches. The next morning when I woke up, I had abdominal pain, which became localized in the lower right quadrant. My friend, who is a nurse, told me I should go to the ER as it sounded like I had appendicitis. I was admitted at to the hospital  on 1/16. After blood work and an abdominal CT, the diagnosis was acute appendicitis. Dr.  performed a laparoscopic appendectomy at 7 AM on 1/17.  I was discharged that night. On 1/25, I started running a fever. Blood work revealed my WBC to be 33,000. Dr. asked me to return to the ER. My fever spiked to 104.6 and I was admitted to the hospital for 5 days of IV antibiotics to manage an infection in my abdomen. By 1/31, my WBC was down to 11,000 and I was discharged.
h/a, diffuse arthralgias, 11x 7 cm, warm, erythematous, raised indurated plaque @ site of inj LUE;
Flashes in the corner of OS and floaters in OS for several days. Headache on 11/15/2021, 11/16/2021 and 11/17/2021.