chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Td and MMR. Experienced a vasomotor collapse with loss of consciousness. Diaphoresis-lips blue, resp shallow, weak pulse. Assisted onto the bed in nurses' office. CH called. O2 started 10ml/mask, Epnephrine 0.3cc sub. Began responding within one minute. Remained pale-paramedics responded within 6 min. Within one hour walked to car with mother.
sore throat, esophageal pain, globus sensation Narrative:  12/23/2020 - felt like she had a lump in her throat. This persisted to 12/24/2020. on 12/25/2020 developed centralized chest pain and discomfort. No history of heartburn or indigestion.  12/25/2020 - went to ER. Diagnosed with esophageal spasm
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-JUN-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-APR-2016, the patient was treated at a medical center for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Extreme trouble breathing, extreme fatigue, heart palpitations, tachycardia over two months. Put on high doses of prednisone.  Still have problems with breathing on exertion of lifting or going up stairs.
patient reported to Hospital ER 5/19/19 with 101.4 fever diarrhea, cough,  runny nose and not feeding, hx of MMR vacation on  5/16/19 was dx with fever and nasal congestion no labs or tests performed  patient reports to PCP office 5/21/19 for ER f/up stating pt running fever x 5 days highest 103, presents extremely fussy, red faced and diarrhea was dx with fever and abdominal pain
Swelling of right eye only.  Swollen almost shut.  The swelling slowly reduced over 24 hours.
pt recv vax 1NOV96 & 12NOV96 pt devel 2 pox on chin w/sores in mouth & fever of 101.5;pt could not sleep or eat;
Patient started to experience some upper arm pain in her left arm on the day of the vaccine. It continued to get worse throughout the night and by the next morning she had pain shooting down her left wrist. She presented to the MD office after 21 days with persistent pain and tenderness in left arm.
Gave a monovalent instead of the bivalent Pfizer vaccine, no signs or symptoms, no treatment needed, and no adverse outcomes.
had a rash that was itchy and painful on his abdomen; had a rash that was itchy and painful on his abdomen; had a rash that was itchy and painful on his abdomen; This case was reported by a physician via sales rep and described the occurrence of itchy rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced itchy rash, painful rash and pain. On an unknown date, the outcome of the itchy rash, painful rash and pain were unknown.   The reporter considered the itchy rash, painful rash and pain to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a rash that was itchy and painful on his abdomen. The reporter said that, the rash did not look like shingles and did not think it was vaccine related but was requesting additional safety information for Shingrix. No further information was available.
Mom called stating she came home from school 24 hours after recieving H1N1 vaccine with hives on her neck and back. They kept spreading and encompassed her back, chest, stomach and face. No fever. Just itching. Mom called Dr and was told to give her Benadryl or to get some Claritin. Mom gave Benadryl and the hives went away. About 4 hours later they came back. She gave more Benadryl and they go away. No other problems and this is the second dose.
Patient received first dose of Pfizer covid-19 vaccine. While waiting in the pharmacy for 15 minutes, patient began sweating, pulling mask down and looking nervous. Patient stated that she felt like she was going to pass out. I lowered patient to the floor, flat on her back and elevated her feet in a chair. Her mask was removed and an ice pack was placed on her forehead. We provided patient with orange juice as well. After some time laying down, she was able to sit up on the floor and waited seated on the floor for additional time and drank the orange juice. After an additional 10-15 minutes, patient felt that she was no longer feeling faint and was comfortable to leave the pharmacy.
I contracted COVID-19. I had a head cold and headaches. I took Tylenol for my symptoms. I didn't feel great. I went to the Emergency Room. I took a COVID-19 test and it was positive. I also contracted COVID-19 in February 21, 2023. I developed laryngitis.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no allergies (medications, food and other products).  Concurrent medical conditions included Asthma (20 years ago. There was no change in status such as improvement or worsening.) and Diabetes (20 years ago. There was some improvement.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, METFORMIN and EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (sore arm). In January 2021, PAIN IN EXTREMITY (sore arm) had resolved.            It was reported that after the second dose, the patient had experienced a sore arm for 1 or 2 days. The patient had not experienced a similar event in the past. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). No treatment was given for the event.   This case was linked to MOD-2022-599990 (Patient Link).
27 Y.O female was received Moderna Booster vaccine lot# 084J21A on 1/21/2022 at 1720. Patient started having hives, redness on her neck and chest area. Patient complained of itching on her upper chest area and her left arm. Denied shortness of breath. Benadryl 50mg/1ml IM to right deltoid muscle was given. No adverse reaction noted. at 1740 patient's BP was 150/85 HR 77. 911 services was offered to the patient due having continued redness on her chest area. Patient refused the service. Educated regarding allergic reactions to seek emergency services if reaction persist. Patient released to a care of a family member.
PATIENT'S MOTHER CALLED IN TO PHARMACY TO INFORM US THAT THE PATIENT WENT TO BED THE NIGHT OF GETTING VANCCINATED AND WOKE UP THE NEXT MORNING 8/30/2021 WITH SWOLLEN LIPS, FACE AND CHEEKS. PATIENT TOOK SOME BENADRYL AND IT SWELLING WENT SUBSIDED SOME WHAT. MOTHER WAS ADVISED TO TAKE PATIENT TO THE E.R.
Pt recv vax on 2/3/99; on 2/4/99 pt exp erythematous, tender, warm, swelling of left upper arm
pt died at home; per death certificate, pt's causes of death:  hypertensive heart disease with heart failure, COVID 19, dementia
Body ache; Fatigue; Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), PAIN (Body ache) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 25A21A) for COVID-19 vaccination.     The patient's past medical history included Subfertility (Failed to conceive after a year plus of trying. Referred to fertility clinic for IVF.). Previously administered products included for an unreported indication: MARIJUANA from 2008 to 2013, NICOTINE (1 Pack/day- 3mg 60ml/week) from 2009 to February 2020, PHENCYCLIDINE (Daily) from 2012 to 2013 and TDAP. Concurrent medical conditions included Depression since 2020, Alcohol use (1 drink/week) since 2006 and Allergy to plants. Concomitant products included BUPROPION, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Jul-2020 and the estimated date of delivery was 23-Apr-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Body ache) and FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred, which was reported as Full-term. For neonate 1, the birth weight was 4026 grams (8lbs 14oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. Length- 20 cm, Head circumference- 34.29 cm. On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. On 13-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PAIN (Body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.   This case was linked to MOD-2021-069764 (Patient Link).
06/24 I had dry throat and thought it was from travel. 6/25, had a low-grade fever 99.4 and I took a at home COVID-19 test which was negative. 06/26, I had a fever with a reading of 100.4 and I don't usually get a fever when I sick, so I took at home test for COVID-19 and it was positive. I had a headache, sinus congestion and a mild cough (it wasn't bad). 06/27, I called my doctor and I had a tele visit with a PA. During the video visit I was given a prescription for PAXLOVID. I started taking the medication as prescribed and anything to help the fever. I didn't need to take anything because all symptoms were very mild. 06/28, I felt a little better I might have had a slight fever but not too serious. 06/29, I felt so much better maybe a little congestion but so much better. 06/30, I tested and I was 100% better and I tested negative.
12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown); Dose administered after 30-day Use By Date:; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date:) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date:) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date:) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022. 9 Boosters 3rd dose and 3 second doses (Lot# 051B22A & Exp. Date: unknown)) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date:).    No concomitant medications were reported.  Monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-Jul-2022 and Beyond use date was 05-Aug-2022. 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19-Sep-2022 until 09-Nov-2022. 9 Boosters were 3rd dose and 3 second doses. No previous excursion was there. Beyond use date was 05-AUG-2022.  The vial was initially stored in the refrigerator on 06-Jul-2022. 6 Patients received on 19-Sep-2022, 2 Patients 04-Oct-2022, 1 Patients on 06-Oct-2022, 1 Patient on 09-Nov-2022.   The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 4th of 12th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
WE WERE AT OUR LOCAL STORE GETTING ITEMS AND PATIENT STATED THAT HE WAS FEELING FUNNY-HIS EYES WERE MOVING RAPIDLY BACK AND FORTH AND WITHIN MINUTES HE FELL BACKWARDS AND WAS CAUGHT BY AN OFFICER WORKING AT THE FRONT AND HAD A SEIZURE - CALLED 9-1-1 -- AMBULANCE TOOK HIM TO THE ER AND WAS TOLD HE DID HAVE A SEIZURE AND HAD BLOOD WORK/CT SCAN OF HEAD AND CHEST XRAY -- ALL CAME BACK CLEAR.
KNOT FORMED AT INJECTION SITE; KNOT LOOKS BRUISED; SORENESS AT THE INJECTION SITE/KNOT FEELS SORE; This spontaneous report received from a patient concerned a 44 year old female. 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 not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced soreness at the injection site/knot feels sore. On 06-JUN-2021, the subject experienced knot formed at injection site. On 06-JUN-2021, the subject experienced knot looks bruised. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at the injection site/knot feels sore, knot formed at injection site and knot looks bruised was not reported. This report was non-serious.
This spontaneous report was received from a physician assistant via a company representative and refers to a 2 year old male patient. It was reported that the child has never had any problems and was not immunocompromised. No information regarding concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date and exact dose were not reported), subcutaneously. On an unknown date, the patient developed a rash on his left side. The patient sought medical attention, was seen by a physician and a culture of rash was taken. The result came back positive for varicella zoster (date of test was not reported). The patient was treated with acyclovir (unspecified dosage). The physician assistant stated that they did not see any reason for other concerns. The outcome od the event was reported as recovering. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Patient received 1st Moderna dose 8/5/21 and second Moderna dose 9/3/21.  Patient developed fatigue, weakness, fever and shortness of breath on the day of the second vaccination - patient developed neutropenic fevers post vaccination and it was noted that the patient had a similar reaction after the first dose of Moderna vaccine.  All work up for sepsis negative.
generalized rash 48-72hr & 12 days post vax w/hep B description by mom most c/w urticaria;
Patient was given COVID-19 vaccine on 10/11/23 by Pharmacy.  Patient's last COVID-19 vaccine (prior to that one) was 9/1/2023. Patient received covid vaccine before recommended time (per the CDC).
Information has been received from a nurse practitioner concerning an "over 60" year old female patient with hypertension and cholesterol high, who on 09-JAN-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (Lot # 663177/1413X). On 23-JAN-2009, the patient developed fever blister on lips after getting ZOSTAVAX (Merck). The patient sought unspecified medical attention. On an unspecified date, the patient had recovered. Follow up information has been received from a registered nurse concerning a 65 year old female patient with iodine, hydrochlorothiazide (WAES # 0904USA04510) and sulfa allergy, depression, hypertension and hyperlipidemia, who on 09-JAN-2009 at afternoon was vaccinated with the first dose ZOSTAVAX (Merck) (Lot # 663177/1413X) 0.65 mL on the left triceps. Concomitant therapy included atenolol, PAXIL and LIPITOR. On 09-JAN-2009, laboratory tests performed showed the following results: white blood cell count low 3.8 K/uL (4.0-11.0); questionable viral illness. On 05-FEB-2009 at 09:44 (also reported on 23-JAN-2009), the patient experienced fever blister and was treated with VALTREX, 1 gm BID for 5 days. On 17-FEB-2009, chest X-ray was performed which was normal. On 19-FEB-2009, the patient experienced cough and no energy, she was seen and evaluated, the patient complained of being ill for 4 weeks (felt like when she had mono). The oral fever blister had resolved. Fatigue persisted. On 25-FEB-2009, was reported that on 20-FEB-2009 glucose, kidney, liver test, complete blood count, normal limits. Viral titers showed chronic mono, like viral infection. Laboratory results showed the following results: blood eosinophilic leukocyte count 8% (0-7), serum Epstein-Barr virus nuclear antigen immunoglobulin G antibody test in range 9.1 U/mL, serum Epstein-Barr virus early antigen immunoglobulin G antibody test high 10.2 U/mL, serum Epstein-Barr viral capsid antigen immunoglobulin M antibody test in range less than 10.0, the interpretive table showed a chronic infection. On 05-APR-2009, the patient recovered from the adverse events. No further information is available.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 COVID-19 PNEUMONIA
I started itching about an hour and a half after getting the shot. All of my body. Took an allergy pill and it dissipated after about two hours. That evening my arm started hurting like I had been punched or stabbed.   Starting on the 30th, the day after getting the shot, my arm was too sore too move higher than shoulder level and a welt/rash of some kind developed on my bicep below the injection site.   Today, two days after the shot, my arm is still extremely sore and the welt/rash is still on my arm but seems to be fading a little.
Sore at injection site; Fatigue; Flu like symptoms; Twitching in my left arm; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534), via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN); experienced drug allergy. Prior to the vaccination, the patient was unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 30Mar2021 the patient experienced sore at the injection sight and felt super fatigued with flu like symptoms and twitching in the left arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events of vaccination site pain, fatigue, flu-like symptoms and twitching. The clinical outcomes of the events vaccination site pain, fatigue, flu-like symptoms and twitching were unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Injection site redness (deep redness); Injection site tenderness; injection site itching; Body ache; headache; Injection site tenderness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), HEADACHE (headache), the first episode of INJECTION SITE PAIN (Injection site tenderness), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness (deep redness)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PAIN (Body ache), HEADACHE (headache), the first episode of INJECTION SITE PAIN (Injection site tenderness) and FATIGUE (fatigue). On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness (deep redness)), the second episode of INJECTION SITE PAIN (Injection site tenderness) and INJECTION SITE PRURITUS (injection site itching). At the time of the report, PAIN (Body ache), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Injection site redness (deep redness)), the last episode of INJECTION SITE PAIN (Injection site tenderness) and INJECTION SITE PRURITUS (injection site itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.