chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021/ did not receive the second dose because she missed the appointment; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received only one dose of the Moderna COVID19 vaccine on Dec 07 2021 / did not receive the second dose because she missed the appointment).    Concomitant product use was not provided by the reporter. It was unknown if the patient has received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
Face swelling that started with lower lip then moved up to cheeks and upper lip.  Around 6:45 a.m. I took 40 MG of Prednisone but swelling continued to get worse. At 8 a.m. I called my GP office and his office instructed me to go to the hospital immediately. The hospital gave me another 20 MG of Prednisone and 80 MG of Famotidine and kept me on a heart and BP monitor until 12:00 p.m. I was discharged from the hospital with a prescription for Prednisone and Famotidine. The swelling started to reduce by about 10:30 a.m. but was not completely gone until around 8 a.m. 11/9/2021.
Noted 10-30-11 per mom on exam 1/2" x 1/2" indurated lesion, skin color painful to touch. Examined on 10-31-11.
At about 11:15am I was driving home from getting my MRI results and an unexpected flu shot at the hospital when my shoulder at the injection site started itching intensely. Then my entire arm felt as though it was on "fire" and burning. I then PASSED OUT. I ran off the road, hit an embankment, went airborne, and rolled over in my car several times. Had to be air-vacced to nearest hospital.
Meniere's disease 2004-2007 went into remission until 2020 reappeared and got worse progressively, possible exposure to COVID-19 but not tested passed out for 3 days Feb2020. After 2nd dose - mild and was tired for two days fatigue and sore.  Already had Meniere's disease and just got progressively worse with vertigo. A lot of nausea and throwing up. Seeing doctors for Meniere's disease and finding ENT and neurologist.
First night (7 hours after shot): rabid itching that started in the neck. It moved down the left side of my body. Then went down the right side of the body  from top to bottom each time. Treatment - antihistamine (Claratin)   8 days later a red, hard, raised "mark" appeared at the shot site. It was itchy and slightly warm. Treatment: topical anti-itch spray.
Two weeks post vax, the bone in the palms of both hands hurt when putting pressure on them. It continues to this day. Three months post vax, the pt woke up in the middle of the night with both hands frozen in claw-like position. When sleeping this happens every 2-4 hours. They hurt and I have to work them back to normal. They continue to do this and they swell up too. The pt was treated for carpal tunnel syndrome but orthopedic doesn't think that is all of her problems. She went to a rheumatologist that did a lot of blood work but nothing shows. The follow up letter received on 10/5/00 states, "the pt presents today for follow up evaluation. The pt is followed for hand discomfort and presents today for a check. She has been using her splits at night. Her carpal tunnel sympptoms appear to be improved although she still has some discomfort about her hypothenar eminences. She has been using Motrin without significant relief. On examination from today the pt does have some discomfort about her hypothenar eminences. No significant discomfort in her fingers. Impression and plan: overall the pt at this point seems somewhat improved. We will continue conservatively. If she has increasing pain and discomfort we will re-evaluate her. We will see her back as needed."
Nausea - No vomitting  Seen by EMT. Discharged home at 1230pm
Received first injection of GARDASIL.  Suffered throat constriction and inability to breathe; nausea; fainting.  Patient reported later it was unlike asthma attack, which affects chest.  This was throat constriction.  Two puffs of albuterol did not help; symptoms fortunately abated and patient recovered on own.
patient received the vaccine Subcutaneously instaed of intramuscularly/no adverse event; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16-year-old male patient who was vaccinated with 0.5 mL (once) INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] via subcutaneously instead of intramuscularly (batch number UT7041JA and expiry date 30-Jun-2021) at an unknown site on 20-Oct-2020 for prophylactic vaccination (incorrect route of product administration).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination (latency was on same day).  At the time of report, patient had not experienced any adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient is a 36 y/o F here for her 2nd Moderna vaccine this AM. After being observed for 15 minutes pt c/o N/V and ran to the bathroom. Vitals 140/89, 98% RA, 105. Retook vitals after pt stood up (140/95, 100% RA, 83) and pt still c/o Nausea and dizziness. While exiting the restroom the pt fainted as I was assisting her out. I called for help and guided her to the floor. Dr. was on site and assessed the pt. She was initially tachycardic but improved immediately. cool and clammy to touch. Pt had LOC for approximately 15-20 seconds following episode. Vitals: 135/89, 98%RA, 79. After symptoms improved pt was escorted to an exam room where we monitored her for the next hour. Vitals: 0842-129/89, 99% RA, 84; 0847-134/94, 100% RA, 77 with c/o nausea 7/10. At 0852 Dr. assessed pt again. Pt still c/o nausea; isopropyl alcohol sniff provided and PO water; sx improved, but pt needed to "urinate" and was escorted back to the bathroom by myself and her husband. Pt was able to urinate, upon finishing she stood to walk out; I noticed pallor and clamminess, and she then fainted again. I guided her into the chair I had brought into the bathroom and Dr helped me to guide her to the ground; he auscultated a rapid weak radial pulse; slowed breathing: then she "snapped to". Pt did not have any seizure activity but RUE wrist flexed, pressed against wall. Vitals: 132/84, 100% RA, 71. After the second episode; called 911 to help transport the pt for farther evaluation. FD arrived at 0937 to evaluate the pt. Blood glucose was 80, vitals WNL. Pt still c/o Nausea/dizziness/headache on evaluation. Pt transported by EMS to Hospital.
stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Patient came to pharmacy 8/21/19 after getting immunizations 8/19/19. Patient states she was short of breath from the vaccines. Patient's left arm was red and slightly raised. Patient was told to use Benadryl and was given an ice pack. Patient was kept in pharmacy in chair for 45 mins to monitor symptoms since she was short of breath and refused to contact/go to the doctor's office or ER. Pharmacist contacted doctor on patient's behalf and he said he would contact her. Tried to contact patient 8/22/19 and 8/23/19 to see if symptoms resolved, but no answer.
Patient went to emergency room on 1/9/22. He had pneumonia and a pulmonary embolism.  He was not admitted.  He was placed on eliquis.  The blood clot dissolve but liquid in his lung became encapsulated. He underwent surgery and was in the hospital 4 days. He is doing well now
wide spread rheumatic sx; characterized by swelling/pain inject; 2 wks p/vax;
Patient was 17 years of age and received the Janssen shot at covid immunization clinic provided by Pharmacy. No issues at time of immunization.
Almost exactly 24 hrs after receiving my Covid Pfizer booser shot (Pfizer-BioN tech Covid-19 Vac, Bivalent EUA), I was at home and suddenly felt very tired and chilled.  I had been to the facility earlier that morning and felt fine and exercised for about 1 hr.  After suddenly feeling chilled and tired, I went to bed and slept for almost 1 hr (I normally never take a nap) under blankets to keep warm.  After waking up, I felt fine and was not tired or chilled.  I have had no other noticeable reaction to the Covid shot.  I was fine the remainder of the day,  going outside and cutting the lawn with a push mower; the day following my reaction I went to the facility and exercised for 1 hr and felt fine.
AST (rapid heatbeat); had a much worse incident of this about 2 weeks after the first dose; only slightly elevated today after 2nd shot.  May have been due to dyhydration, rather than the vaccine, but is hard to tell.
Patient stated before receiving the vaccine that he had very bad anxiety in regards to needles. I administered the shot and the patient immediately said he didn't feel well and asked for water. I went to retrieve water and when I returned he had fainted. He came to within a minute. He laid down on the floor until his family arrived to help him get home.
Wrong Vaccine administered; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong Vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Caller decline consent to describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong Vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong Vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong Vaccine administered).    No concomitant medications were reported. The patient has received the bivalent vaccine over a year ago and the bivalent vaccine was approved in august-2022, which was not completing a year ago as per the narrative. Patient received Primary doses of vaccines and then received a bivalent booster. Patient said that the pharmacy person who gave patient the bivalent did not tell patient that they needed a second dose of the bivalent complete and the time has lapsed (Over a year). Patient explained that the Primary Series was 2 vaccines, and the bivalent was one unless otherwise asked by HCP. Patient insisted that they were supposed to have a 2 dose of Bivalent. As per reported an AE due to the information provided, it sounded like the patient may have received another primary dose when they thought they were receiving the Bivalent booster (1 dose). The caller said patient thought patient heard the last person provided the vaccine that patient got the wrong shot. Caller was impatient and not hearing the information patient was trying to provide. clearly.  No treatment medications were reported.   Reporter did not allow further contact
Patient reported hives, severe itching entire body, labored breathing and severe hypertension, sluggish, body aches and headache.  Saturday evening started feeling better but sore and very tired.  The hives, itching and labored breathing ended about 1.5 hours after starting.
Shortly after vaccination the patient complained of breathing difficulty and "the room was become black"  The nurse attended to her taking vitals, providing water,...vitals reflect the following in order:   1. HR:86, O99%, BP 138/62 (performed on R arm) temp 95.9 2. HR :97, O98%, BP 132//68 (performed on the R arm) temp 93.3 3. HR : 96, O 98%, BP 132/78 (performed on the R arm)  temp 96 4. HR: 66, O 98, BP 138/82 temp 96
pain; Violently throwing up; Shortness of breath; very lethargic; very achy; temperature of 102.5/fever; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (pain), LETHARGY (very lethargic), MYALGIA (very achy) and PYREXIA (temperature of 102.5/fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included APIXABAN (ELIQUIS), METHOTREXATE and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), LETHARGY (very lethargic), MYALGIA (very achy) and PYREXIA (temperature of 102.5/fever). On 12-Mar-2021, the patient experienced PAIN (pain) and VOMITING (Violently throwing up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), LETHARGY (very lethargic) and MYALGIA (very achy) outcome was unknown and PAIN (pain), PYREXIA (temperature of 102.5/fever) and VOMITING (Violently throwing up) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Cold; Patient received 1st dose on May 2021 and 2nd dose on Aug 2021; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on May 2021 and 2nd dose on Aug 2021) 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.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on May 2021 and 2nd dose on Aug 2021). In October 2022, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on May 2021 and 2nd dose on Aug 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Tested for Covid twice and the results were negative.         No concomitant medications were reported. Patient had cold 2 weeks ago and it was almost 95 percent recovered. No treatment information was provided.
General achiness throughout body and head ache.  Achiness began the morning after the delivery of the second dose of the vaccine.  I did not have any adverse reaction to the initial shot of the vaccine.
Shingles; Rash; This is a spontaneous report from a Pfizer Colleague.   A non-contactable consumer (Patient) reported that a unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose, the patient developed shingles. Not certain if it was related but my doctor reported it to withheld. After a couple of days, the patient developed a rash (different than shingles) all over my body. At first doctor thought it was poison ivy, but it was quite severe. The patient was treated with vytrex for the event shingles and for the event rash, patient was on steroids (unspecified) for 12 days. It's been more than 5 weeks now; patient still had the rash (it's calming down since this past weekend but still had new rash). Patient did not know if there's any connection to the vaccine, was there other similar incidents.Neither steroids or antihistamine seemed to help much. The outcome of the event shingles was resolved on an unknown date. The outcome of the event rash was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial solicited report received on 09 November 2017 from an investigator participating in the study. This case involves a 70-year-old male subject who developed respiratory arrest during the study participation. The subject's medical history and concomitant therapies were not reported. On 03 November 2017, same day after receiving a single dose of intramuscular dose of blinded therapy on 03 November 2017 (batch number unknown), the subject developed respiratory arrest. This subject was admitted with acute HF and afib on 02 November 2017. On 03 November 2017 subject was randomized in Invested. At this time the subject was not decompensated HF. Subject reported no previous flu vaccine. At the conclusion of the 20-minute monitoring period the subject reported coughing and sniffling and then within hours of vaccination fever of 101.4 was noted. Per hospital staff subject was given Tylenol for fever. On 04 November 2017, subject developed dyspnea which was treated with bipap as well as transfer to ICU. Once in ICU subject became unresponsive requiring intubation. Per pulmonology consult, the subject was not in decompensated HF rather acute respiratory failure. Pulmonology and nephrology consults were also uploaded with hospitalization form. At this time the subject remained in ICU on ventilator. Classified as possibly related. According to the investigator, the seriousness of event was considered as life threating due to prolonged hospitalization. Other lab data was not reported. The subject had corrective treatment with (Paracetamol) Tylenol. The event of respiratory arrest was resolving at the time of the report. According to the investigator, the event was related to the study vaccine or trial procedures. Relationship to investigational product according to company: associated. List of documents held by sender: none. Sender's Comments: A 70-year-old male subject had respiratory arrest on the day of receiving study vaccination. He was admited for acute heart failure and atrial fibrillation and next day received study dose. Within hours of vaccination he had fever evolving to acute respiratory failure next day. Based on time to onset and morbid condition of subject, the possibility of event due to study vaccine can not be ruled out.
Received its 30-days Exp date; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received its 30-days Exp date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2022 at 11:57 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Feb-2022 at 11:57 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received its 30-days Exp date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received its 30-days Exp date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was White.  No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. Dose was given at 27-Feb-2022 11:57:32.  No treatment medication was reported by reporter.
soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in his arm). At the time of the report, VACCINATION SITE PAIN (soreness in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Mother reports that on the morning of 10/17/16, patient complained of leg pain but continued to play. Pain became constant and more bothersome later that afternoon. No swelling, redness, or warmth in either lower extremity. Vaccine was administered in his left thigh; mother reported to one provider that pain started in his right leg but reported to another provider that pain started in his left leg and then moved to his right. Presented to the ED on 10/20/16 for pain and was found to be febrile.
2 Y/O Received FLUZONE, HIGH FLU DOSE FOR elderly population: wrong dose, wrong medication. Was observed by pediatric department for 45 minutes, vital signs were normal.