chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) outcome 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 (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    It was reported that, the patients involved are all over the age of 65.  No concomitant medications was reported.  Date of administration of vaccine are 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient).  No other adverse events have been reported.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
Short term symptoms(1st and 2nd dose): sore arm, dizziness, headache, nausea  long term symptoms( after 2nd dose): irregular period, heavier period than normal, extreme menstrual pain (back, stomach aches, cramps, migraine, lethargy, nausea) period happening every other week.
Currently on Day 4 of confirmed covid.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Currently on Day 4 of confirmed covid.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 02-Dec-2021 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced COVID-19 (Currently on Day 4 of confirmed covid.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 30-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Currently on Day 4 of confirmed covid.) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient stomach bile taste in her mouth from the drug made her feel so gross she started to regurgitate. Couldn't get past it. Patient Did feel an improvement in covid symptoms and currently on Day 4 of confirmed covid. Company comment: This spontaneous case of concerns a 41-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no onset date; hence, latency to the booster dose of mRNA-1273 vaccine cannot be assessed. No details of previous doses were provided. As per source document, she received Paxlovid as COVID-19 treatment approximately 4 months after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case of concerns a 41-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no onset date; hence, latency to the booster dose of mRNA-1273 vaccine cannot be assessed. No details of previous doses were provided. As per source document, she received Paxlovid as COVID-19 treatment approximately 4 months after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt came to medical due to feeling like her heart was pounding. Pt was alert and oriented, acting normally, skins: pink, warm, dry, pupils equal and reactive to light. vitals: 1000 BP: 136/84, HR 80, RR 16, SPO2 100%, 1007 BP: 134/80, HR 83, RR 16, SPO2 98%. PT complaining at time of second set of vitals that her face felt numb and was very sluggish and slow to speak.  Pt asked if she had taken any medication today, specifically her hydrocodone and she stated that she had not. Stroke assessment completed, -arm drift, =grips and pulls, symmetrical smile, normal speech except slow to speak. Pt does have family cardiovascular hx as well as cerebrovascular hx. Pt agreed to be transported to hospital for further evaluation by a physician.  911 was called and pt was transferred to transport paramedics with no significant change in status.
Client c/o a nerve discomfort from the vaccine site to the side of Left neck up to the jaw area. Advised client for another 15 minutes of observation. Client stated OK. NP was made aware and NP spoke with client. BP was taken at 146/84. Ox at 98% HR at 76, temp 98.7. Client was monitored for another 15 minutes BP was taken 10 minutes later with 143/83, Ox at 98, HR 75. Patient stated that she is okay. stated that the nerve discomfort is no longer present.  Client left clinic stable with steady gait.
Patient reports that approximately 1 1/2 hours after getting first HPV vaccine had severe nausea and vomiting, some diarrhea, headache, felt light headed and had difficulty breathing. Two days later went to ER after driving himself up to the mountains and was given an IV, IV medication for nausea and vomiting and that "knocked him out". When he woke up he felt somewhat better, but still lethargic.
Per MD's office; face and arm was red and complaining of feeling hot. BP 140/98 and MD gave shot of Benadryl and prednisone in office and sent home with prescription for Benadryl and prednisone. Per pt; she started experiencing nausea, seeing spots (black, red, orange). Face was red, felt really hot and started itching. She complained of heat, edema, nausea, red all over; broke out in welts.
Fatigue, aches, chills, fever, diarrhea for at least 24 hours as of this writing.
Patient received covid vaccination on 9/5/2023 from a vial that was removed from the refrigerator on 9/1/2023 and sat at room temperature for 4 days.  Vaccine was no longer viable at time of administration
Vertigo, body aches, headache first 2-3 days. Then a few days later major fatigue set in, chest pain, mouth breaking out in canker sores randomly, broke out in hives, rashes on my legs and arms, skin hurts to touch, dizzy, loss of balance, difficulty sleeping, night sweats, blurred vision, double vision this is probably the worst of all the symptoms, I lost my taste for 5 weeks. I have taken anti-viral homeopathic drops because it really felt like I was getting the chickenpox or something...like a nerve pain burning. I have documentation how perfectly healthy I was before this and now I am not.
Vaccination failure; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61--old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: FP&141) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs and ampicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "recovered" (Mar2023), described as "COVID 19"; VACCINATION FAILURE (medically significant) with onset 2023, outcome "recovered" (Mar2023). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid 150(x2) from 03Mar2023 to 08Mar2023 for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108567 same patient, different product;
Swollen arm 15 minutes after administration of vaccine. Bad headaches 4 days, disrupting sleep and work.
RN administered Moderna Bivalent Booster to patient who has not had a primary series mRNA vaccine. The patient did not have any adverse reactions
chest pains worsened; chest pains worsened; costochondritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (003110). The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Jan2021 (unspecified if ongoing), notes: COVID; "mild chest pains", start date: Jan2021 (ongoing), notes: mild chest pains. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "chest pains worsened"; COSTOCHONDRITIS (non-serious) with onset 2021, outcome "unknown", described as "costochondritis". The events "chest pains worsened", "chest pains worsened" and "costochondritis" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My 19 year old daughter had mild chest pains when she had Covid in Jan2021. When she received the first Pfizer vaccine, her chest pains worsened and it has not gotten better today. The doctors say it's costochondritis. We have tried everything and she has taken several tests and x-rays. Nothing is helping her and these chest pains are preventing her from participating in her sport at college. Do you have any data on this matter and how to treat. We don't know how to remedy this. Please help  The lot number for bnt162b2 was not provided and will be requested during follow up.
High Fever  Severe myalgia  Rigors  Purpura to legs  Swollen axillary lymph node
Information has been received concerning a pt who was vaccinated on 07/15/99 with her first dose of varicella vaccine. On 06/30/00 the pt broke out with spots of chickenpox scattered all over her body. the pt sought unspecified medical attention.
Swelling, redness at injection site. Mild flu-like symptoms for 24 hours. (Aches, chills, fever of 100).
Pain at the sight of injection which adversly affects day to day activities such as dressing and other regular uses of the arm.
This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of PROQUAD (Merck) (doses and routes were not reported) lot # K020751, expiration date 30-APR-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
unilateral nongranulomatous anterior uveitis; This is a spontaneous report from a contactable physician. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 15Apr2021(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Patient medical history was reported as none. Concomitant medication was not provided. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. It was unknown, if prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Apr2021, the patient experienced unilateral non-granulomatous anterior uveitis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with topical steroid(unspecified). The clinical outcome of the event unilateral non-granulomatous anterior uveitis was recovered unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Iridocyclitis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Pain in arm, swollen, redness, headache, nausea.  I took Advil so I could sleep.  It was painful to even have clothes on arm or have arm touch mattress or sheet to sleep.
Pt recv vax on 3/17/99; on 3/29/99 pt exp fever (99.4), chills, chest rash x 48 hr; tx=Benadryl
Early menstrual cycle I received my second Pfizer, COVID 19 vaccine on June 1st. Three days later I had an early menstrual cycle, only eleven days since I had stopped menstruating. This had never occurred before, or has since. This proves that the vaccine causes hormone changes.
sore throat; dry cough; high fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), COUGH (dry cough) and PYREXIA (high fever) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. it was unknow if the patient previously receive a COVID-19 Vaccine.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), COUGH (dry cough) and PYREXIA (high fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), COUGH (dry cough) and PYREXIA (high fever) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.   The patient did not receive any treatment. Device Date  09-Jul-2022   Reporter did not allow further contact
Patient had severe pain (feel like broken ankle) and swollen left arm (twice normal size). Dr advised him to take BENADRYL on 5/16. Patient had less pain and swelling on 5/17.
Presents for worsening SOBx 8 days. COVID + 5days PTA & referred to ER from infusion clinic for O2 sat in 50s (did not receive infusion at clinic). Admit for COVID pneumonia & severe sepsis. Tx: remdesivir, dexamethasone, O2, vit c, vit d, zinc. DC to home on O2.
This spontaneous report was received from a healthcare worker and refers to a 61 year old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 26-NOV-2014, the patient was vaccinated with expired ZOSTAVAX (0.65 ml, subcutaneously, lot#J007208, exp.date: 20-SEP-2014, anatomical location was not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information is not expected, the reporter does not wish to be contacted.
Vaccine was removed from freezer 10-12-2022. Vaccine was viable for 30 days and expired 11-11-2022. Vaccine was administered 12-12-2022.
cold sweat; cramp in kidney; lost appetite; feels fuzzy-headed; whole shoulder is sore; fever between 100 and 101 degrees F that has come and goes; chills; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweat), RENAL PAIN (cramp in kidney), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (feels fuzzy-headed) and PAIN IN EXTREMITY (whole shoulder is sore) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281A27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced COLD SWEAT (cold sweat), RENAL PAIN (cramp in kidney), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (feels fuzzy-headed), PAIN IN EXTREMITY (whole shoulder is sore), PYREXIA (fever between 100 and 101 degrees F that has come and goes) and CHILLS (chills). At the time of the report, COLD SWEAT (cold sweat), RENAL PAIN (cramp in kidney), DECREASED APPETITE (lost appetite), FEELING ABNORMAL (feels fuzzy-headed), PAIN IN EXTREMITY (whole shoulder is sore), PYREXIA (fever between 100 and 101 degrees F that has come and goes) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: high (High) High 100 to 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient regained a small appetite on 13 Apr 2021, but had no appetite on 14 Apr 2021.  Treatment included tylenol.
Information has been received from a nurse practitioner at a student health center concerning a 20 year old female student with no known drug allergies who on the afternoon of 9/23/03 was vaccinated IM with a first 10 microgram dose of hepatitis B virus vaccine (lot # 644078/0940M). Concomitant therapy included topiramate, minocycline and fluoxetine HCL. On 9/24/03, the next morning, the patient appeared and had developed hives on her upper and lower extremities and chest tightness. The nurse treated with patient with epinephrine at the student center and then transferred her to the hospital emergency room where she was monitored for several hours and released. It was unknown what, if any, treatment was initiated at the hospital. On 9/25/03, the next day, the nurse practitioner had phone follow up with the patient who told her that she was feeling better and recovered. no product quality complaint was involved. Upon internal review, hives on her upper and lower extremities and chest tightness were determined to be other important medical events (OMIC). Additional information has been requested. A 15-day follow up report received 12/02/2003 adds: Upon internal review, joint stiffness, generalized hives on her upper and lower extremities and chest tightness were determined to be other important medical events. No further info is expected.
Lightheadedness; Mild Chest pain Close to center of chest; Heart beats high 77/Min; Hurts if breathe; Cough; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), CHEST PAIN (Mild Chest pain Close to center of chest), HEART RATE ABNORMAL (Heart beats high 77/Min), DYSPNOEA (Hurts if breathe) and COUGH (Cough) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV positive.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Lightheadedness), CHEST PAIN (Mild Chest pain Close to center of chest), HEART RATE ABNORMAL (Heart beats high 77/Min), DYSPNOEA (Hurts if breathe) and COUGH (Cough). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lightheadedness), CHEST PAIN (Mild Chest pain Close to center of chest), HEART RATE ABNORMAL (Heart beats high 77/Min), DYSPNOEA (Hurts if breathe) and COUGH (Cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
First week after, I got arm pain, headache, fever - slight fever (99.6). The second week after, I had nausea. The last two weeks (before getting the second dose) I got super sick - my breathing got restricted. I started running a fever again. 1-22-2021 - I went to Clinic - Respiratory Infection; Acute Exacerbated Asthma; Prescribed another albuterol inhaler and Prednisone steroid (2 weeks) to open up the lungs. I had the second dose on 2/5/2021. - I haven't had another asthma episode since then.
ED visit for unstable angina and then hospital admission for Coronary artery bypass grafting x3 with left internal mammary artery anastomosed to the left anterior descending artery, saphenous vein graft to the right posterolateral artery, and saphenous vein graft to the second obtuse marginal artery. This visit was within 6 weeks of receiving the COVID vaccine.
Chills; fatigue; headache; nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm) in a female 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 03-Feb-2021, the patient experienced CHILLS (Chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm). At the time of the report, CHILLS (Chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
A day after I got shot #2  my left shoulder was stiff and painful.  It got worse and got to the point that I could nearly raise my arm.  2 months later my shoulder is very painful and my arm is still sore at the injection site.