chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chilly; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilly) and HEADACHE (mild headache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient has unknown allergies (medications, food and other products). Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of Vaccination reported as unknown.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CHILLS (chilly) and HEADACHE (mild headache). At the time of the report, CHILLS (chilly) and HEADACHE (mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   The patient has no ever had COVID + test or diagnosis.  Recent change in status such as improvement or worsening was unknown.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose) reported as was unknown.  Manufacturer and dose of all COVID-19 vaccinations received (Complete for each COVID-19 vaccine received). It was unknown that the adverse events cause patient to seek medical care such as (office visit, Urgent care, ER, hospitalized). It was unknown that the patient has experienced a similar event in the past.  The patient's symptoms improved.  Treatment medications were not reported.   This case was linked to MOD-2022-542609, MOD-2022-542613, MOD-2022-542615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow-up received contains no new information
One night I felt itchy in my armpit and the next day I was still itchy and cortisol did not help. So it turned into itchy hives which moved from one part of the body and moved to another spot. I took Benadryl and it helped and the next day I read about hives and it suggested taking Zyrtec. That helped. I took it for about 10 days and stopped and the itchiness came back about 2 days after so I started back taking the Zyrtec. My PC recommended Zyrtec for a full 14 days and referred me to an allergist. I went off the Zyrtec for a week before my appointment and was itchy with no hives. The allergist did not test me for anything he just indicated that it is a immune reaction and to keep taking the Zyrtec. I have continued taking Zyrtec for about a month now.
Since my second booster I have now had COVID a third time. I have had COVID three times since January 2022. After conversations with my doctor, we have spoken about whether my body is having a hard time really getting rid of the virus. I have had adverse effects to all vaccines. I am in the process of being tested for issues relating to fatigue and there is concern that I could unknowingly be experiencing some sort of "long COVID" side effects.
pt recv vax 9DEC96 & that day pt exp terrible tiredness & a mild fever;pt sx persisted @ the time of the report;
The day after the vaccine, pt. awoken on 02/04/2021 @ 0700 with swollen right and left hands and wrists.  On day 8 after the vaccine 02/11/2021, pt. started to get a red rash that started on his chest and moved to the upper back then to the arms and legs.  The rash did not itch.  No treatment per pt.   Today 02/18/2021 pt. states that his left wrist is slightly swollen and the rash is still present but fading.  Pt. states that he did not have any difficulty with breathing.  Pt. did not seek medical care.
This spontaneous report as received from a physician and nurse via company representative refers to two patients (age and gender unspecified). The reporter learned of 3 patients that have developed a rash after receiving ZOSTAVAX, reporter stated that at least one of the 3 patients was a female and two with unspecified demographics. Patients concurrent conditions and medical history were unspecified. It was reported that in between 27-JAN-2014 to 07-FEB-2014, each patient were vaccinated with ZOSTAVAX Subcutaneous Injection, (Lot number: J008433, expiry date: 11-OCT-2014), (dose was unspecified). Approximately in 2014 (reported as sometime after 27-JAN-2014), the patients had developed a rash after receiving ZOSTAVAX. It was reported that the most severe rash reported may have also been previously reported through the vaccine adverse experience report number (VAERS) reporting system and included a rash that was 8-10 millimeters or centimeters in diameter. The other 2 rashes reported were less severe (it was unspecified out of three patients which patient had developed the most severe rash). Lot Number for the diluents for 2 out of the 3 vials was also provided Lot J012748 for both vials. All three patients came in for follow up visits with the physician for unspecified reasons. No product quality complaint was involved. The outcome of event rash was unknown. The reporters causality for the event with the therapy of ZOSTAVAX was not reported. This case is linked with case 1402USA007867 as same reporter link. Additional information has been requested.
This is a 31y.o. female with PMHx of migraines who presents to ED with a complaint of abdominal pain and vomiting x 2 days. She reports that her pain has been off and on over the last several months and has acutely worsened over the last few days days, now constant. Pain located in epigastric region with radiation to back. Patient states the pain is worse with eating cheese. Has not noticed a change with other dairy products, gluten. States she has not eaten much over the last several days because she has felt nauseated. Has vomited several times, non-bloody, non-bilious. She has noticed that her stool has started to have mucous in it and has become tan and chalk-colored. Patient denies diarrhea but does admit to occasional constipation. Denies melena, hematochezia. Denies personal or family history of gastrointestinal issues. Has never had a colonoscopy. Denies history of autoimmune disease. Patient only drinks a glass of wine socially. No history of gallbladder issues. No recent steroid use. Denies fever, chills, chest pain, shortness of breath, palpitations. Patient's LMP 12/24-28. Patient states she is not pregnant, uses condoms consistently.   In the ED, vitals as follows: BP 162/100, HR 100, RR 19, T 97.5, SpO2 100% on RA. Labs remarkable for WBC 12.8, lipase > 1200, AST 136, ALT 219, tbili 1.5, dbili 0.8, bicarb 18. Patient found to be COVID positive, asymptomatic. Abdominal US demonstrated cholelithiasis without evidence of cholecystitis, small calcifications within pancreatic head, prominent common bile duct. Patient to be admitted to the general medical floor for further management of acute pancreatitis with consult to GI. Infectious disease will also be consulted for COVID-19 infection.
1/5/21 received shot around 12:00pm. a few hours later left arm pain started.  1/6/20 left arm pain still there, nausea started. late afternoon, slight body aches started.  1/7/21 woke up with severe body aches. headaches. throat is extremely sore and red. nauseated. chills.
Cognitive problems , Brain Fog, uncontrolled movements , hand & head Followed by Dizziness
Irregular periods. This happened in June, which was sometime after the vaccine and before the 4th, however it did start after I contracted COVID 19. It has gotten worse with the irregularity since my 4th vaccine. Which was also Moderna. However, I had no initial reaction to the vaccine that was abnormal, these problems all started after I got COVID.
Information has been received from a physician concerning a 15 year old female with no known medical history, drug reactions/allergies or concomitant medication use who at the end of August 2007 (exact date unknown), was vaccinated (site and route not reported) with the 1st dose of Gardasil (dose and lot# not reported). In the beginning of October 2007, the patient became very tired and later jaundiced with a low hemoglobin at 5. Laboratory evaluations revealed IgM positive to Epstein Barr virus, positive cold agglutinins, positive antibodies to mycoplasma and positive antinuclear antibodies (ANA). The patient was admitted to the hospital with Autoimmune Hemolytic Anemia for 2.5 weeks with blood transfusions given. The patient was discharged from the hospital (exact date not reported). The patient had been receiving steroids for approximately one week and was undergoing a steroid taper. The physician felt that the patient's tiredness, jaundice and Hemolytic Anemia were considered disabling and life threatening and other important medical events. No ongoing hemolysis at the time. At the time of this report the patient was recovering. Additional information has been requested.
PATIENT CLAIMED TO HAVE BAD RED, SWOLLEN REACTION AT SITE OF INJECTION.
Projectile Vomit and runny diarrhea, lasted 3 days. Hospitalized.
abnormal heart beat; felt a tingling in her chest; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt a tingling in her chest (paraesthesia), and abnormal heart beat (arrhythmia).  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient felt a tingling in her chest. Three weeks later, on 14 Feb 2021, the patient was admitted to the hospital for an abnormal heart beat. No treatment information was provided. At the time of this report, the patient was still suffering from the symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, felt a tingling in her chest and abnormal heartbeat, were not recovered/not resolved.; Reporter's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
approximately two weeks after shot developed hives at random areas of my body.   I am taking Benadryl and have made an appointment with an allergist.  I have never had this type of rash before.  The run up my arm, or down my leg, sometimes on my stomach or back, head, ears, fingers.  They come out at random times and go away after an hour or if I take medication.
12:10 h/a, t98.6, BP 120/76;sore rt arm;12:15 gen weakness conf 911;12:30 BP 120/80;
Patient noticed some tingling their right hand after the vaccine was administered in their left deltoid. Pharmacist on duty told them to monitor it and if it got worse to seek medical attention.
Immediate dizziness - 45 minutes , on 4/27, severe itching and rashes, slow weight loss, no appetite, exhaustion, Oral Lichen Planus discovered spreading from tiny area before shot
Exposure to Pregnancy; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure to Pregnancy) in a 28-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in October 2020. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfur based medicines), Depression since January 2013, Anxiety since January 2013 and Exercise induced asthma since January 2005. Concomitant products included SERTRALINE for Depression, DOXYLAMINE SUCCINATE (UNISOM 2) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. The patient's last menstrual period was on 02-Feb-2021 and the estimated date of delivery was 07-Nov-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure to Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Exposure to Pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Ultrasound scan: baby heart rate 163 Baby heart rate of 163 measuring 7wld.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken were pre natal vitamins, Sertraline, Unisom. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Pregnancy case, no AE On 21-Jun-2021: Pregnancy update, no new info added
This medically confirmed spontaneous report (initial receipt 24-Oct-2013) concerns a 33-year-old female patient with no pertinent medical history or allergies. Concomitant medication included tretinoin and unspecified vitamins. On 27-Sep-2013, the patient was vaccinated with intramuscular AFLURIA (batch: R53207) in the left arm, at a dose of 0.5mL. On the same day, after vaccination, the patient developed soreness, loss of range of motion and strength, in her left arm. The patient believed the vaccination may have been injected a little higher than normal. When the symptoms first appeared it caused her significant disability and affected her quality of life. On 09-Oct-2013, the patient saw a healthcare provider and had a shoulder x-ray, which was normal. The healthcare provider stated that the patient had an inflamed muscle in her left arm and prescribed naproxen and daily stretching exercises. The patient reported that her symptoms had gotten better but were not 100 percent.
Shaking; Chills; Temperature spike to 103.7 fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Chills) and PYREXIA (Temperature spike to 103.7 fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking), CHILLS (Chills) and PYREXIA (Temperature spike to 103.7 fever). The patient was treated with PARACETAMOL ( acetaminophen) (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), CHILLS (Chills) and PYREXIA (Temperature spike to 103.7 fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7 (High) 103.7.         No concomitant medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Telephone contact report received on 28-JUL-2021 in which lab data added. Events outcome were updated.
CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/2/2023 & 2/7/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a health professional concerning a female who was IM vaccinated with her first dose of GARDASIL (lot number unspecified). Subsequently the patient experienced a red mark where the band aid came into contact with skin at injection site, which was not from the stickiness of the band aid. The patient sought unspecified medical treatment. Additional information has been requested.
Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case from a health care professional. This case involves 18 months old female patient who received fourth dose of 0.5 mL dose of vaccine DAPTACEL lot C5171AA, expiry date- 23-Mar-2019 via unknown route in the left thigh on 26-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; HEPATITIS A VACCINE; and INFLUENZA VACCINE. It was a case of actual medication error due to Expired vaccine used. It was unknown if any adverse event was occurred. 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 and Module VI of the 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. Documents held by sender: none.
Pain began immediately upon injection. I have received flu shots regularly and pain has never lasted more than 2-3 days. Currently, the shoulder pain is unresolved more than 4 weeks after injection. Pain is increasing in severity, and unresolved as of date of this report. It will likely require some type of medical intervention.
Patient who received first CoVax 10Apr2021, was later diagnosed with COVID-19; Patient who received first 10Apr2021, was later diagnosed with COVID-19; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for a female patient of an unspecified age received bnt162b2 (reported as Covid-19 Vaccine), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first 10Apr2021, was later diagnosed with COVID-19, asked if we can provide any medical advice in regard to receiving second dose. The event outcome was unknown.  Information about lot/batch number has been requested.
Tingling in left arm - symptoms comes & go. About  no time specific - doesn't know how long it lasts. Approximately 1 minute.
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number not reported). Concomitant vaccination included MENACTRA and DTP (manufacturer unknown). Subsequently, the patient experienced neck pain and axillary pain. She was prescribed MOTRIN and rest. The physician mentioned that the patient is a tall girl. The patient sought medical attention by making an office visit. Additional information has been requested.
Cold-Like Symptoms; Headache; Vaccine given 1 day beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of NASOPHARYNGITIS (Cold-Like Symptoms), HEADACHE (Headache) and EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  Concurrent medical conditions included Drug allergy (Hydroxyzine) and Penicillin allergy.    On 23-Feb-2023 at 1:40 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Feb-2023 at 1:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD). On 24-Feb-2023 at 9:00 AM, the patient experienced NASOPHARYNGITIS (Cold-Like Symptoms) and HEADACHE (Headache). On 27-Feb-2023, NASOPHARYNGITIS (Cold-Like Symptoms) and HEADACHE (Headache) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NASOPHARYNGITIS (Cold-Like Symptoms), HEADACHE (Headache) and EXPIRED PRODUCT ADMINISTERED (Vaccine given 1 day beyond BUD) to be related.    It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event.  Moderna Bivalent Booster (AS7170B) used by date was reported as 22-Feb-2023. Upon lot assessment it was reported that the vaccine administered on 23-Feb-2023 from lot number AS7170B, maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The patient was notified at time of initial discovery of event as well as notified when the lot assessment was complete. The events did not cause the patient to seek medical care.  No treatment information was provided.
migraine; she is still feeling sick; Sinus infection; she has diabetes and her blood sugar was over 300; canker sore; felt like she was going to die; nauseous; throwing up all night; fever; Chills; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300) and APHTHOUS ULCER (canker sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) and IRBESARTAN (AVAPRO) for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; AMOXICILLIN at an unspecified dose and frequency and CODEINE at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Treatment drug also included Compazine. She was given antibiotic and pain medication also.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Concomitant drugs were added. Treatment medications were added. New events canker sore, sinus infection, body aches, fatigue, blood sugar was over 300 and felt like she was going to die were added.
Injection site hurt and swollen the size of a softball. Advised to take BENADRYL as directed and apply cold compress.
Pt received shot 8pm on 8/24/09. Awoke at 6:30am on 8/25/09 with headache that lasted 3 hrs.
rash at injection site- getting smaller but now itching- has not taken Benadryl yet Pt will start taking Benadryl  now and will , ER if s/s worsen or do not improve