chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild tenderness near injection site when pushed on; Mild pain near injection site when pushed on; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Mild tenderness near injection site when pushed on) and VACCINATION SITE PAIN (Mild pain near injection site when pushed on) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TENDERNESS (Mild tenderness near injection site when pushed on) and VACCINATION SITE PAIN (Mild pain near injection site when pushed on). On 04-Apr-2021, TENDERNESS (Mild tenderness near injection site when pushed on) and VACCINATION SITE PAIN (Mild pain near injection site when pushed on) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was scheduled to take Botox injection for migraine on 09-Apr-2021.  Concomitant product use was not provided. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-Jun-2021 contains no significant information.
We took a bath and when we removed her shirt we notice 4 red rash spots on right side of upper back
Extreme fussiness and unconsolable; Tenderness from the knee to the thigh; after receiving VAXELIS swelling at the injection site on the thigh and fever; Fever/ Pt reported a 100.9 temp; Redness & swelling at the site where vaccine was given/ from knee to the thigh; This non-serious spontaneous safety report with reference number 02320717 was received by a partner on 19-JAN-2023 and forwarded on 20-JAN-2023 from a health care professional.  This case was considered non-valid given that no patient identifiers were provided (the reporter was not sure of the patient's age).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the event "after receiving VAXELIS swelling at the injection site on the thigh and fever".   Further information is expected.  FOLLOW-UP Information was received by partner on 25-JAN-2023 and forwarded on 26-JAN-2023 from a health care professional.  The case is considered valid (Patient identifiers provided).  The reporter assessed the events, "after receiving VAXELIS swelling at the injection site on the thigh", "Redness & swelling at the site where vaccine was given/ from knee to the thigh" and fever/ Pt reported a 100.9 temp" as related to Vaxelis. The reporter did not provide an assessment of the causal relationship between Vaxelis and the events, "Extreme fussiness and unconsolable" and "Tenderness from the knee to the thigh".  Follow up information is not expected.
Woke out of a deep sleep with sharp back pain between shoulderblades especially, entire spine pain, hip joints intense, all other joints (limbs, fingers, toes, neck, etc.) throbbed with intense pain. Felt like blood, hair, finger & toe nails, everything was on fire. Started throwing up at 5:00 AM and continued violent vomiting for 2 1/2 hours. Was very weak, hard to hold arms up, fatigued (restless sleep), fever/chills, sweats, body and top of head, confusion, loud ringing in ears (this continues today), diahhrea, eyes hurt, felt like shingles of the entire body, stiff neck, across back/shoulder, mid-back, and low back.
Mom states pts temp got as high as 106 & pt had sz; EMS brought pt to ER where pt was worked up; according to mom no source of infect was found; pt was released from ER & followed by pvt MD;
70 y/o who presents with localized chest tightness/reflux, pain that began after injection. No other complaints No cardiac risk factors. Pt states prior hx of symptoms non relieved by relaxation. Exam- unremarkable Plan-observation. Requests to go home unlikely allergies. Observed Pt Provided pt option to go to ED for cardiac eval. take herself to ED/urgent care or contact her MD. Risks/benefits explained to patient. Pt chose to go home BP 124/82 P 97 Resp 16. BP 126/88 P 87 Resp 16. BP 128/88 P 68 Resp 16.
pain in entire body; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (pain in entire body) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain in entire body). At the time of the report, PAIN (pain in entire body) had resolved.            Concomitant medication information was not reported.  The patient had pain in entire body for a few days after first, second and third doses of Moderna COVID vaccine.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742972 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742972:Case for 3rd dose of vaccine
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) continuously testing positive for COVID-19 even after 14th day since 1st symptoms.         No concomitant medication was reported. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. From 21-May-2022 to 24-May-2022, other medication Tylenol was administered. Patient was continuously testing positive for COVID-19 even after 14th day since 1st symptoms  Device Date was reported as 05-Jun-2022  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 5 days and had rebound, continuously testing positive for COVID even after 14th day since 1st symptoms. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 5 days and had rebound, continuously testing positive for COVID even after 14th day since 1st symptoms. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Administered expired dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 07-NOV-2022) for prophylaxis.   On 20-JAN-2023, the patient received Shingrix. On 20-JAN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Administered expired dose of Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient was administered an expired dose of Shingrix, which led to expired vaccine used. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023080477:Same reporter US-GSK-US2023080475:Same reporter
This medically confirmed spontaneous report (initial receipt 08-NOV-2014) concerns a female patient. On an unspecified date, the patient received trivalent inactivated influenza vaccine (manufacturer and batch number not reported).  ON an unspecified date after receiving the vaccination, the patient developed hives. Outcome was unknown.
Product storage error; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 26-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
I woke up in severe pain and itching two days after getting the first injection. There was a shooting pain in my neck down the spine, hands l, feet and left buttock. I realized later that morning that I was covered in hives. My hands and feet were swollen, very red and sensitive to the touch as well as a sensitivity to heat.  I took benadryl and Aleve to help with itching and pain for 3 days and it never got any better so I went to urgent care. The provider told me that I was having a allergic reaction to the vaccine. He also told me that I appeared to have cellulitis on my buttock and a UTI. I was given two steroid shots, antibiotics and hydroxyzine and warned me not to get the second dose of the vaccine. Four days went by and the pain and itching seemed to get worse. While I was at my daughter's Dr office (Allergy Asthma and Immunology) for an appointment, the nurses noticed my rash was purple and told me that they wanted to have someone look at it for me. The provider gave me another steroid injection and oral steroids and again advised me not to take the next injection until I have been skin tested. This seemed to help calm my skin. Then I began to peel all over and I am still peeling. June 9th I followed up with my PCP and was told again that the rash was a allergic reaction to the vaccine and that it had actually cause burns. What the urgent care provider thought was cellulitis on my buttock was actually a second degree burn. It is slowly healing.
07/26/2022 I was at work felt completely fine and near the end of the work day I started to cough up mucus. I took a test for COVID-19 and it came out positive. When I woke up in the middle of the night I had a fever, I was cold. I reached out to my Rheumatologist right away and I was given PAXLOVID and after taking it the fever broke immediately however the other symptoms continued to persist. I had occasional cough, sore throat, headache. After finishing the cough got better and headaches went away, but the sore throat is still lingering. As of today I am still tired and having the sore throat.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-NOV-2021, the patient underwent COVID-19 virus test (NR: not provided) Positive (confirmed clinical vaccination failure, and confirmed covid-19 infection). On 21-NOV-2021 (Day 7), patient's lungs were inflamed, irritated, and easily winded. The patient reported that, "Tested positive for Covid on 14-NOV-2021 despite getting the J and J shot in April. It whooped my butt. I ended up getting monoclonal antibody treatment which made a huge difference in my recovery. We were learning the J and J shot isn't as effective as Jensen is painting it to be. By day 7 my lungs felt inflamed, irritated, and was easily winded. I made an appointment with a treatment center. I was afraid it would progress and did not want to end up in the hospital. Thankfully I was still within that 10 days window.'' The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211988.; Sender's Comments: V0:20220127908-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20220127908-covid-19 vaccine ad26.cov2.s-Confirmed Covid -19 infection.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
developed chills, fever and body aches 1-29-21 Was feeling better 1-31-21 and went to work. That evening body aches worsened and on 2-2-21 she can hardly move due to back ache, body aches and stiffness
Patient reported that when he received the vaccine he looked over and saw the syringe against his arm and liquid running down his arm that was wiped up by the  person giving the vaccine. He was concerned that he did not et the full dose of vaccine. After review of recommendations and literature, patient was scheduled and received another dose of vaccine on 2/19/21.
LIGHTHEADED, HYPERTENSIVE, ABLE TO GO HOMEAFTER SYMPTOMS RESOLVED.
Body aches; Fever; Couldn't sleep; Arm soreness; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 05-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness). On 09-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left  arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat.  01/01 - EE notes that her arm was very sore and she had a bad headache.  As the days went on, it got redder, hotter, and more swollen.  On 12/20, she began to feel bad.  On  12/28 while at work, she heard that her supervisor was COVID (+).  Throughout the day she felt worse and worse.  Was seen at urgent care and COVID was negative.  Prescribed Cephalxin and predinose  01/01 -- arm is much better today.  Today it is still bruised.  She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
Patient feel nausea, lightheadleness. EMS was at patient side for 10 min . Water given. After the 30 minute patient stated " I feel ok now". Patient left to go home.
Information has been received from an office manager concerning a 70 year old female with no pertinent medical history and no drug reactions/allergies who on 13-JUN-2008 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 659407/0295X). Concomitant therapy included ACIPHEX. On 10-JUN-2010 the patient experienced shingles. There was no lab diagnostics study performed. FAMVIR and prednisone was given for treatment of shingles. The patient sought unspecified medical attention. At the time of this report, the patient has not recovered yet. The office manager considered shingles to be an other important medical event. Additional information has been requested.
COngestion, sore throat, loss of taste, fatigue, sore arm \ Narrative:
This spontaneous report as received from a physician via company representative refers to a 67 year old female patient. The physician reported that, on an unknown date (reported as in the past), the patient received ZOSTAVAZ (dose, route of administration, lot # and expiration date not provided) and, on 11-JUL-2014, developed ophthalmic zoster, zoster near the eye. The physician prescribed to the patient unspecified antiviral therapy and referred her to an unspecified ophthalmologist. The outcome of ophthalmic zoster was unknown. The relatedness between the event and the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Red rash (itchy and hurts) roughly 5 inches in size, running down arm, under injection site. Did not want to treat symptoms, just wanted us to be aware of reaction.
Raised, red, hot swollen, entire shoulder is itchy from morning of Day 2 to present (Day 3).  Diarrhea 24 hours later.  Headache.
I also had a second shingle shot in left arm. Developed chills and body aches for 24 hours
After i gave covid-19 Janssen shot to patient, he passed out (Syncope), out of anxiety and nervousness from the shot per patient and his wife. Incident happened around 3:40 pm. His senses soon come back. We called emergency (911) and they ran some test and took the patient to the emergency. Patient was in senses, responding and alive when he left .
Vaccine was given a few hours after it expired and patient was notified and they had no adverse effects.
Pt had a grand mal seizure, lasting 4-5 mins, according to mother. Was taken to ER had CBC and CT scan of head (both wnl)-then saw neurologist on 10/23/03 and EEG done (also wnl). No further work-up or follow-up recommended unless pt has another seizure. The medical records received on 1/21/04 states lethargy, and bite tongue.
Aside from the bruising at my injection site on my left upper arm, I have developed a reddned area below. The area is warm to touch, can feel a bump inside, slight soreness. It is not painful.
pt recv vax approx NOV96 & pt devel chickenpox w/15-20 lesions primarily on face, scalp, extremities & trunk as a result of the vax;
This spontaneous report was received from a consumer regarding a female patient (reporter's friend's young daughter) of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL (lot# unspecified). No concomitant medications were reported. Since vaccination with GARDASIL, the patient now had seizures. No Product Quality Complaint (PQC) was reported. The outcome of seizures was not reported. Causality assessment was not provided. Upon internal review, seizure was determined to be medically significant. Additional information has been requested.
Elevated heart rate beginning about 7 hours after vaccination. Normal resting heart rate is 62-65bpm. Sustained elevated heart rate of 90+ bpm for 48 hours post vaccination. Also elevated blood pressure 135/85, when blood pressure is usually normal. Low grade fever 99.5 for about 24 hours after vaccination. Elevated heart rate then became bradychardic with resting heart rate of 50bpm from 48 hrs to 96 hours post vaccination. Normal resting heart rate did not return until 5+ days post vaccination.
Slight fever, tired, diarrhea,, slight nausea, sore spot on arm, muscle aches, heart racing.
Pt received influenza vaccine at PCP office. 1 hour after vaccination, (B) LE weakness developed and progressively worsened on 9/11/08. On 9/12/08, the pt was seen at a clinic and referred to the ER for further eval. Pt came in to ER on 9/14/08 w/ continued (B) LE weakness. Neurological evaluation revealed probable Guillain-Barre syndrome w/ IVIG treatment.9/22/08-records received for DOS-9/14-9/18/08-DC DX: Lower extremity weakness, presumably, possibly Guillain-Barre syndrome status post IVIG treatment. CSF showed cyoalbuminologic dissociation. Strength improved discharged to home. Presented to ED with C/O weakness that began 4 days prior. Abrupt onset and constant, right and left leg and foot weakness. Weakness began same day as receipt of flu shot. Upper respiratory infection one month prior that lasted 2-3 weeks. Difficulty walking.