chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a pretty bad reaction to them; In my opinion my eyesight has improved; took none of my prescribed meds; slept off/on the whole day; tiredness; chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, VACCINATION COMPLICATION, INTENTIONAL DOSE OMISSION, THERAPEUTIC RESPONSE UNEXPECTED and FATIGUE in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation, Glaucoma and Macular degeneration.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE and CHILLS. On 27-Mar-2021, the patient experienced SOMNOLENCE and INTENTIONAL DOSE OMISSION. On an unknown date, the patient experienced VACCINATION COMPLICATION and THERAPEUTIC RESPONSE UNEXPECTED. On 30-Mar-2021, FATIGUE and CHILLS had resolved. On 31-Mar-2021, SOMNOLENCE had resolved. At the time of the report, VACCINATION COMPLICATION, INTENTIONAL DOSE OMISSION, and THERAPEUTIC RESPONSE UNEXPECTED outcome was unknown.            No concomitant were provided by reporter. No treatment details were provided.   This case was linked to MOD-2021-036777.   Most recent FOLLOW-UP information incorporated above On 26-May-2021: Additional events added. On 22-Jul-2021: Follow up received, Current condition glaucoma and muscular degeneration were added. Vaccination complication event was updated.
This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Covid-19 infection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Clinical effectiveness of additional primary SARS-CoV-2 vaccine doses for solid organ transplant recipients. Clinical Transplant. 2022;36(3): e14601. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19 infection) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Covid-19 infection) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Covid-19 infection) to be related. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This is a literature non-study case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected serious adverse event of special interest COVID-19, which led to hospitalization, 2 days after receiving the third dose of mRNA-1273 vaccine (no information disclosed on previous doses of COVID-19 vaccine). Date of vaccination and onset of event were not specified. No details about the clinical course, diagnostic procedures and treatment were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-528036, MOD-2022-528035 (Patient Link). Sender's Comments: This is a literature non-study case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected serious adverse event of special interest COVID-19, which led to hospitalization, 2 days after receiving the third dose of mRNA-1273 vaccine (no information disclosed on previous doses of COVID-19 vaccine). Date of vaccination and onset of event were not specified. No details about the clinical course, diagnostic procedures and treatment were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
No further AE/No PQC; administration of pediatric doses of RECOMBIV AX HB to 3 adults; administration of pediatric doses of RECOMBIV AX HB to 3 adults; This spontaneous report was received from a medical assistant, referring to an adult patient of unknown exact age and gender. Information about medical history, concomitant medications, concurrent conditions and drug allergies was not provided.  On 27-JAN-2022, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 5mcg/0.5ml, 1 dose, lot# U001837 was confirmed to be valid, expiration date reported as 21-NOV-2022, however upon internal validation was established as 28-APR-2023 (route and site of administration not provided) for prophylaxis. It was reported that the dose administered was a pediatric dose (incorrect dose administered, product administered to patient of inappropriate age). No additional adverse events reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA004223: US-009507513-2203USA004333:
OFF LABEL USE; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 202A21A expiry: UNKNOWN) 1 ml, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced inappropriate dose of vaccine administered. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate dose of vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210416254.
Felt really sick for a couple of days after the vaccine; my arm got extremely sore. I had chills. I just felt like my body had been bruised all over. No treatment.  Most recent Symptoms - About four weeks ago, Friday before I got the cough medicine (8/2/2021) I thought I saw blood in my stool. My sinuses were draining, I started coughing and my eyes were watering. By Monday morning I was coughing and hacking like I had a really bad cold. All the mucus was clear. He gave me cough medicine - August 2nd  (and that eased the cough and by Friday I was feeling better. Everything was okay - with stool and he did a swipe test (A swab on a card to test since I had seen blood in my stool).
patient received three doses of vaccine; dose two was beyond 36 days from first dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received three doses of vaccine) and INCORRECT DOSE ADMINISTERED (dose two was beyond 36 days from first dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A., 037K20A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (patient received three doses of vaccine) and INCORRECT DOSE ADMINISTERED (dose two was beyond 36 days from first dose). At the time of the report, EXTRA DOSE ADMINISTERED (patient received three doses of vaccine) and INCORRECT DOSE ADMINISTERED (dose two was beyond 36 days from first dose) had resolved. Not Provided      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.
SKIN SENSITIVITY; NECK SORENESS; BACK SORENESS; HEADACHE; SHAKYNESS; FLU LIKE SYMPTOMS; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to morphine and Codiene. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 09-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-APR-2021, the subject experienced skin sensitivity. On 09-APR-2021, the subject experienced neck soreness. On 09-APR-2021, the subject experienced back soreness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced Shakyness. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced overall weakness. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin sensitivity, Headache, Shakyness, and flu like symptoms, and was recovering from Neck Soreness, Overall Weakness, and Back soreness. This report was non-serious.
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received Shingrix. On 12th March 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know, what was best to take Aspirin or Tylenol for arm pain.
Patient reports receiving the first Moderna vaccination on 8/16/2021 and experiencing sudden intense headache, nausea, blurry vision, and vertigo within a few minutes of receiving the injection. Patient went on to develop a localized rash to her neck. Patient reports symptoms improving after several days, but becoming even more intense after her second Moderna injection on September 16th. Patient reports that her symptoms have not improved since the second Moderna vaccination, and she states now she has developed severe photophobia requiring sunglasses to be worn even indoors. A rash to her neck that appears to be in the later stages of healing is noted to her neck.
Less than 10 minutes after receiving influenza vaccine, patient noticed metallic taste on roof of mouth.  It disappeared after lunch but noticed again in afternoon, then disappeared and has not recurred.
First, experienced muscle aches and spasms from injection site (left arm) extending through trapezius muscles to other (right) arm including  temporal/jaw pain.   Then, experienced drop in body temperature where I was cold despite 5+ blankets; would be cold for 2-3 hours then cold sweats for few minutes (repeating episodes).  Discomfort when breathing (costal condritis-like symptoms).  Symptoms lasted for about 36-hours.
swelling right axilla Narrative: Employee called PCP on 10/14 and states she was advised this is a normal side effect and if it is not improved she states she was advised to call back and schedule a visit.
5 months after receiving 1st booster developed fever, headache, upper respiratory congestion & cough for 4 days of fever and about 10 days of coughing and congestion
Patient received vaccine. About 10 minutes later reported feeling of an "itchy tongue". There was no visible swelling, not erythema or other evidence of allergic reaction. Gave patient 25mg of BENADRYL and monitored for 30 additional minutes. Patient followed up with her primary care physician.
On 10/17/2022 I woke up with a lot of head congestion. We returned that day from an extended vacation. On the flight my symptons became worse; headache, sore throat and very congested.I became slightly fevered and disoriented as well as dehydrated. I assumed it was a sever head cold and it did not get down into my lungs. I took two home tests as noted in section 19 and contaced my doctor after the second test. She provided instruction for dealing with the COVID as well as a perscription. By the weekend (Oct 22-23) I was for the most part recovered but continued my isolation until the 10th day.
CDC reports: 9 mo child developed fever to 103 following immunization, lasted 1 day.
Patient had an allergic reaction to the 1st dose of Pfizer's Covid-19 shot, she spoke with her doctor before getting  her 2nd shot and he advised to take 50mg of Benadryl and 40mg of Famotidine 30 minutes before the shot which she did. After receiving the shot, it took less than 15 minutes for her to start breaking out on the right half of her body and itching all over. She remained for the whole 30 minutes and notified her doctor during this time.
Mom states p/immun given 26FEB91 pt was very limp w/eye rolled back & then was sick for 2 wks & would not suck bottle; Did not see MD or return to clinic (temp unk);
Pfizer-BioNTech dose 1 vaccine was administered on 01/13/2021. Pfizer-BioNTech dose 2 in the 2-dose series was administered 1 week early on 01/27/2021, only 14 days after the 1st dose, rather than within the recommended 17-21 days. The series was not repeated.
This spontaneous report was received from a nurse via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-SEP-2018, the patient was vaccinated with GARDASIL 9 (dose and route of administration not provided, lot # N035955, expiration date 09-OCT-2020), and an approximately half of the dose leaked out around the syringe tip and resulted in patient receiving partial dose. No adverse effect was reported.
This case was reported by a nurse via call center representative and described the occurrence of headache in a 49-year-old male patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). On 19th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 19th April 2018, 4 hrs after receiving SHINGRIX, the patient experienced headache, pain and nausea. On an unknown date, the outcome of the headache, pain and nausea were recovering/resolving. The reporter considered the headache, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving supplement. On 19th April 2018, at about 1 pm, the patient received SHINGRIX vaccine in the left arm at reporter's facility. At about 5 pm, the patient had headache, nausea and was feeling achy. The patient continued to have the same symptoms in morning on the date of reporting but they were better.
Client sitting in chair in lobby after getting a TBST and a flu shot. She indicated to the person she came to the health department with that she was not felling well. He in turn called for the  nurse. That nurse called for this nurse and when I arrived, client was being lowered to the floor.  She was non responsive and pulse was weak. She started to have a seizure. This lasted approximately 1 minute.  Her eyes opened and she immediately tried to get up.  We explained where she was and what had happened.  EMS was called  from down the hall and they took over care of client.
1025A Reports "hot" and feel flushed, headache. Hx migraines, color pale. Clammy. Administered BENADRYL 20 ml po. BP 130/73 HR 90 R- 20. 1050A Headache resolved BP 102/72 HR 82.
no adverse event; administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Dec-2022, the patient experienced NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022). At the time of the report, NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022).    Moderna is authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022.  No Concomitant medication were provided by reporter. No Treatment medication was provided by reporter.
Pain in right arm, fever, chills, nausea, extreme tiredness all day April 9 to approximately 6 a.m. April 10; symptoms slowly improved through April 10, fever until early morning April 11, as of today pain in right arm and tiredness still an issue.
I am a healthy active 75-year old male. This was my 2nd dose of SHINGRIX (1st dose was a little over 2 months ago. Reaction was extreme chill and fever 100.2. I had to get into bed under heavy covers to warm up. Episode lasted several hours. MY CONCERN IS THAT A PATIENT WHO IS IN A WEAKENED CONDITION AND OLDER SHOULD BE MONITORED FOLLOWING THIS VACCINE. HAS THERE BEEN AN EVALUATION OF THE RISK DURING A VACCINE REACTION ON OLDER WEAKENED PATIENTS?
Given Flu Vaccine at work site night shift woke up next day with severe joint and body aches, while resolved. Extreme fatigue until 10/23/2019. Unable to work 10/21 and 10/22. 10/24/19 all Sx resolved.
passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on head that is swollen and bruised; cut on my left side of neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533), via an unspecified route of administration in left arm on 24Mar2021 at the age of 48 years old at a single dose for COVID-19 immunisation. Medical history included asthma controller, anxiety. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergy. Approximately 15hrs after receiving vaccine, On 25Mar2021 at 01:15, patient had severe dizziness with nausea feeling sat down and then passed out waking up after (unknown length of time) on the floor. Patient stated "i had struck my head and my left neck/shoulder on table and wall. Now I have huge knot on head that is swollen and bruised and a cut on my left side of neck." Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up Information has been requested.
13:50 The mother complained of patient being nauseated. Approached patient, noticed she was really pale. C/O dizziness and not feeling well. Placed feet up in a chair and assisted patient while other nurse grabbed the gurney. Patient started to gain some color. Transferred to gurney by one-person assist. Placed on supine position. Mother and brother at bedside. 13:55 Slowly lifted up as tolerated. Patient's color close to normal. Instructed to start drinking fluids. Denied any nausea. Patient felt better. Denied any dizziness. 14:10 Placed in sitting position. Patient felt back to baseline. Per mother, color is back to normal. Encouraged to drink at least half of the water in the bottle. 14:15 Sat patient on the side of the bed. Asymptomatic. 14:20 Ambulated. Denied dizziness or lightheadedness. Patient and mother comfortable going home. ED precautions provided and instructed to follow up with PMD. Mother verbalized understanding.
Patient experienced redness at site of injection. Doctor saw patient and advised patient to give BENADRLY once at home.
Ten days after injection, the arm began to itch and turn red. There was no knot and no heat was felt. It has gradually decreased, but is still visible.
Breakthrough case admission after 4 vaccines Pfizer 2/23/21 Lot# EN6200;  Pfizer 3/16/21 Lot# En6207;  Pfizer 8/24/21 Lot# Ew0173;  Pfizer 4/9/22 Lot# FP4554
pt recvd vax & exp purpura 1MAY93 & exp purpuric rash on extensor surfaces of both legs; pt was seen by MD; 5MAY93 ther was almost total resolution of purpuric rash;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: about 6 minutes after 1st dose was administered, pt complianed of lightheadedness, dizziness, nausea and sweating. His BP was 113/61, pulse was 46. he lay on the floor and elevated both feet onto a chair and immediately after doing so, the symptoms began to improve. his BP was re-checked at 11.32am 132/73 pulse 58. i reached out to the patient at 12.02pm and he noted that he was not experiencing any symptoms.
mom reports fever 103-104; mom states pt was hallucinating-running from things that were not there; 2 brief (several minutes) epiosdes; most likely secondary to fever;