chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    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 a vaccine past the beyond used by date).    Concomitant medication was not reported.  Treatment medication was not reported.  This case included information of patient 180 out of 190 reported patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 911 called to store by RN who administered vaccine. Patient was waiting 15 min after vaccine and passed out on floor about 5 min after receiving vaccine. RN reports he did not hit his head, was assisted to the floor. Regained consciousness about 1 min later. VSS, BP 127/75, P 97, R 18, O2 93%. \r\nEMS arrived and evaluated pt, glucose 88, reported sinus rhythm on ECG. Patient refused transport to ED by EMS or to go to ED for further evaluation. \r\nPatient stayed and had driver take him home.
This case was reported by a nurse and described the occurrence of joint swelling in a 34 year old male subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. The nurse reported that on the day of vaccination, 01Apr05, the subject had a head and chest cold. The nurse also reported that on an unspecified date before 01Apr05, the subject was antinuclear antibody positive and was referred to a rheumatologist; antinuclear antibody was negative upon his review. Concurrent medications included Azithromycin (Z pack) to treat the head and chest cold and multivitamins. On 01Apr05, the subject received 1st dose of Havrix in the left arm (lot AHAVB021AA). On 02Apr05, 1 day after vaccination with Havrix, the subject experienced joint swelling, ankle swelling and diffuse muscular pain. The pt was seen at a physician's office; however, information on physical examination of swollen joints, warm joints or fluid from joints was not provided. The vaccination course with Havrix was discontinued. On an unspecified date, diagnostic tests performed for arthritis included sedimentation rate (ESR), rheumatoid factor (RF), anti nuclear antibodies (ANA), and C reactive protein (CRP); however, no results were provided. As of 27May05, the events remained unresolved. In the nurse's opinion, the events were unrelated to the use of Havrix and may have been associated with the pt's medical history and/or concurrent illness.
Moderna Dose 1 8/27/21 (035C21A) Moderna Dose 2 9/24/21 (035C21A) COVID Positive 1/13/22 COVID Positive 1/16/22  1/16/22: Patient is a 63-year-old male who presents to the emergency room with some increasing shortness of breath, dyspnea on exertion, malaise, fatigue and generalized weakness.  Also recently since the patient has been feeling ill he has had decreased oral intake.  He denies any chest pain symptoms with no real cough or sputum production symptoms.  No abdominal pain complaints are noted.  Patient did recently test positive for COVID on 01/13/2022. Patient typically uses 2 L of oxygen via nasal cannula and despite this he was still feeling shortness of breath with some dyspnea on exertion.  Patient had to be increased to 4 L via nasal cannula in the emergency room.  Patient has been fully vaccinated for COVID.  No recent medication changes have been made and he denies any recent travel. Patient's medical history, current medications, imaging studies, vital signs, laboratory studies and emergency room records have been personally reviewed as well as the recent primary care visits.  Case was discussed directly with the emergency room provider.  2/27/22: Acute hypoxic respiratory failure  -secondary to COVID-19 pneumonia  -Patient completed course of remdesivir, Abx and toclizumab  -Day # 20 of intubation,d/w Dr. from Pulmonology  -completed course of nafcillin (2/13 to 2/19) for MSSA Bronchitis  -stopped diuresis 2/25/22  -Continue the tube feeds  -Trach and PEG placed 2/25/22   Sinus tachycardia with bouts of bradycardia  -now stablized, pt's HR now in the range of 100-110  -patient had few pauses as per the strip but EKG shows sinus tachycardia on 2/22  -patient's metoprolol adjusted  -electrolyte abnormalities-hypokalemia corrected, normal Magnesium levels  -Follow up ECHO shows improvement of right ventricular function as per Dr.   Leukocytosis  -mild elevation of body temperature at 99F  -blood cultures ordered, no Abx for now   Patient's other chronic medical problems include:  2/5/22 for cardiac arrest post intubation  Mantle cell lymphoma-currently in remission  Stable Platelet count  Improved Liver function tests post cardiac arrest
Information has been received from a physician concerning a 65-year-old female who on 25-SEP-2007 was vaccinated with a "single dose" of ZOSTAVAX (lot # 658083/0885U). On 05-OCT-2007 (ten days post vaccination) the patient developed a shingles like rash on her back. The patient sought medical attention via an office visit with her physician. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
5/23- VERTIGO/NAUSEA   (1-2 hours) ER room visit 5/26- VERTIGO/NAUSEA (24-48 hours) 2nd ER room visit 5/30-VERTIGO (30 minutes) while sitting, after swimming 6/5- VERTIGO/NAUSEA (10 hours) 3AM from my sleep
1 day after 2nd ANTRAX had severe body aches. 4 days after developed rah on arm where shot was given as well as chest tightness, congestion and cough. Took BENADRYL and prescription cough medicine.
Patient received booster dose of Moderna on 3/9/2022 at 1153 using an expired dose with beyond use date of 3/7/2022 at 0430. No harm to patient or monitoring provided. Per CDC guidelines, Moderna manufacturer has been contacted for information on the stability of the vaccine and whether the dose needs to be repeated. The patient will be contacted for follow-up once this information is available.
Moderna Dose 1 7/1/21 (038C21A) Moderna Dose 2 7/29/21 (038C21A) COVID Positive 1/10/22  1/10/22: -Patient is a 64 yo female with medical history of COPD, Ischemic cardiomyopathy, HFrEF, peripheral arterial disease with right leg claudication and  , MI s/p stents, DM, HTN , HLD , CKD -Poor historian due to fatigue  -She is presenting with epigastric abdominal  pain x 1 day, progressive SOB and cough .  -Denies fever , chills, diarrhoea, leg swelling  -She says she used to be on lasix but did not get refilled and has not been on lasix for months  -She is COVID vaccinated  -In the ER vitals remarkable hypoxia 89% on room air requires 2L supplemental oxygen , rest of vitals stable  -Abdominal Xray was unremarkable  -CT chest showed pulmonary venous congestion and changes of mild CHF and stable enlargement of the pulmonary arteries likely representing pulmonary hypertension.  -Lab remarkable for Cr 1.4 ( at baseline) , transaminitis without T bili elevation, normal lactate, pro BNP 6K , trop 0.03> 0.02 , VBG showing PH 7.3, pCO2 47, pO2 63, CBC wnl , INR 1.2, COVID negative. Blood culture sent from the ER.  -She recieved 1g tylenol, duoneb, IV lasix 40mg in the ER  -Patient being admitted for CHF exacerbation and possible COPD exacerbation  -Abdominal pain currently resolved  1/18/22: Patient is a 64-year-old female with a history of MI status post stents, ischemic cardiomyopathy diabetes mellitus, status post colostomy for perforated bowel in 221. She was admitted history of chief exacerbation and cardiology was on consult.  Patient was put on IV diuresis and due to worsening kidney function nephrology was consulted.  Patient was managed with IV diuresis with Nephrology's help.  Patient was transitioned successfully to Lasix 20 mg p.o. daily.  She was also COVID positive and did not receive remdesivir D2 kidney injury but receive steroids during her stay in the hospital.  She is status post IV ceftriaxone and IV doxycycline.  Patient had an oxygen walk test conducted on 01/18/2022 prior to discharge and was discovered that the patient needs 1 L of nasal cannula oxygen on rest and 4 L of oxygen upon ambulation. Patient was discharged with a prednisone taper.  Patient was instructed to follow-up with her PCP in 1-2 days. Patient was discharged home with other services.
that almost killed me; This serious case was reported by a nurse via sales rep and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced near death experience (Verbatim: that almost killed me) (serious criteria GSK medically significant). The outcome of the near death experience was not reported.   The reporter considered the near death experience to be related to Shingrix.     The company considered the near death experience to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter quoted that Shingrix, that almost killed him/her and did not elaborate further. The reporter did not agreed to follow up with GlaxoSmithKline.
Hives, daily reoccurring, very itchy and sore continues over a week and not cleared up yet. Taking oral steroids and antihistamine.
One- Two weeks after 1st vaccine Nail Growth and increased Strength/ Thickness; Increased sense of smell; Metallic taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FA7484) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic fatigue immune syndrome CFIDS", start date: 1992 (unspecified if ongoing), notes: Chronic fatigue immune syndrome CFIDS diagnosed in 1992; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM. Past drug history included: Polyethylene, reaction(s): "Allergies: Polyethylene"; Chlorhexidine, reaction(s): "Allergies: Chlorhexidine"; Dermabond, reaction(s): "Allergies: Dermabond"; Erythromycin, reaction(s): "Allergies: Erythromycin". Vaccination history included: Prevnar 13 vaccine, for Immunization, reaction(s): "Allergies: Prevnar 13 Vaccine". The following information was reported: NAIL GROWTH ABNORMAL (non-serious) with onset 05Aug2021, outcome "not recovered", described as "One- Two weeks after 1st vaccine Nail Growth and increased Strength/ Thickness"; PAROSMIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Increased sense of smell"; DYSGEUSIA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Metallic taste in mouth". It was unknown if therapeutic measures were taken as a result of nail growth abnormal, parosmia, dysgeusia.  Additional Information: If other vaccine in four weeks: No. The patient was not diagnosed with COVID prior to vaccination. The patient has not tested for COVID post vaccination. Facility type vaccine: Pharmacy or Drug Store  No follow-up attempts are possible. No further information is expected.
Drove to vaccination site. Had a coffee and muffin on way down; had a coffee and veggie wrap on drive back.  Once back home and at my computer for day, room started spinning - I made it outside to back porch, then vomited all food and liquid from the morning. I could not stand - felt like a giant hand was pushing me down - so I laid on my back porch for several hours. When I did stand up, the vertigo (dizziness and nausea) was immense. Made it to couch inside and toward evening gradually made it to bed upstairs, crawling part of the way. By the next morning the  spinning still present but about 50 percent less. Better if I kept eyes shut; spinning and nausea if I opened them. This eventually subsided later in day - I was able to hold down crackers and ginger ale.  By the following day (Wed.) I was able to work - the room spinning and dizziness was finally gone. And by this point able to hold down food and liquids.
I had to call my boyfriend because I couldn't get up. I had pain in stomach, a shooting pain to my neck and towards to my leg. I had an intense fever, and I was really hot and dizzy. I didn't have the ability to stand up and that made me nervous, and I couldn't get up the stairs. I had weakness in my muscles, but not how I experience it on that day.  I went from hot and cold and it surprised and scared me.  I had breathing issues, more coughing and labor breathing.  I haven't heard from my doctor. I was given tips to try some home remedies that helped me. It felt like I had covid again.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On 25-JUL-2014 the patient was vaccinated with an expired dose of VARIVAX (Merck), subcutaneous, Lot # reported as 0138AE, Expiration Date reported as: 10-JAN-2014, (dose was not reported). No known adverse effects. Additional information has been requested.
Day 1- 3 of injection, extreme arm pain from injection Day 2 of injection and ONGOING to the present; chest pressure/congestion, difficulty breathing like not able to get a full breath, developed extreme coughing. Day 4 (07/29/22), had vomiting Day 8 (08/02/22), had a bloody nose
One of five infants, immunized from same vial of DTP, devel high fever (103-104) 7 irritability w/in 12 hrs p/immun; Tx APAP & tepid bath; Pt's also recvd HIB-TITER/OPV;
Received shot at 11:45 am.  At 1700 that day developed sensation of racing heart and resting heart rate was 120. Baseline heart rate 80 at rest. This resolved overnight and returned to normal the next day.   On 12/31/2020 develop sore throat and noted red vesicle like rash on my throat with petechia on my cheeks (buccal mucosa) and tongue. Swollen uvula. I had a medrol dose pack and Benadryl which I started immediately and rash/sore throat petechia resovlved 36 hours after starting the Medro dose pack. Unsure if this was related the vaccine but wanted to report just in case.
Several hours after receiving these 2 vaccines in the same left upper extremity she developed fever up to 103 along with swelling and pain in her left deltoid area.
Patient reported to recovery nurse burning in arm, warmness in BLE, and tightness in chest. VS WNL BP 120/70, HR-100, O2 - 98%, Resp. 18. Pt. Reports this is a chest pain she has experienced before, but never the ?warmness?. Writer offered to call EMS for further assessment/transportation, patient refused, patient states she will be able to transport herself to urgent care. VS obtained again prior to patient leaving, remain WNL BP 125/75, HR-95, O2-98%, Resp. 18.
Several minutes after MMR and varicella administration patient felt itchy. Progressed to swelling of lip, flushed face and ears and hives which began to confluence. Initially given 25mg diphenhydramine when itchy, subsequently given EPI.
fluid in her right leg; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (fluid in her right leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 73771) for COVID-19 vaccination.    Co-suspect product included non-company product LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    The patient's past medical history included Breast cancer and Chemotherapy NOS on 08-Mar-2021.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LORATADINE (CLARITIN [LORATADINE]) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced OEDEMA PERIPHERAL (fluid in her right leg). At the time of the report, OEDEMA PERIPHERAL (fluid in her right leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included "Chemo" No treatment medications provided by the reporter.   Patient was reported that "the fluid in her right leg" started on 12-Mar-2021 after receiving the vaccine. She elevated her leg and laid down which relieved the swelling for a while. The patient noted that after taking a pill of Claritin the swelling comes back and after elevating her leg and laying down the swelling reduces.
pt recv vax & exp fever since 25SEP96;that evening pt t101.5;evening of 26SEP temp was 102.7;530AM 27SEP t102;pt was being treated w/APAP & scheduled to see MD on 27SEP;
This spontaneous report was received from a Nurse Practitioner via a company representative who referred to a 67 year old male patient. Patient's pertinent medical history, concomitant medication and drug reaction/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (strength, dose, lot # and expiration date were not provided). On an unknown date, after receiving the ZOSTAVAX, the patient was diagnosed with shingles then after a year from receiving the ZOSTAVAX the patient died. At the reporting time, the outcome of the event of shingles was unknown. The cause of the death was unknown. It was also unknown whether an autopsy was performed. The relatedness between the events and the ZOSTAVAX was not provided. Upon internal review, the patient's death was considered to be medically significant. Additional information has been requested.
Started with a cold sore the wk of 9/7-9/14/09, red dots to tight cheek, pt c/o pain to rash, rash spread over the eye and eye lash; meds prescribed acyclovir and prednisone.
Low grade fever starting on 4/22/2020,  rash started on right thigh evening of 4/23/2020, seen at office 4/24/2020 diagnosed with Erythema multiforme. Treated with oral Zyrtec and steroids.
This spontaneous report as received from a pharmacist via a field employee refers to a male patient of unknown age. Medical history and concurrent conditions were not reported. On 20-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (dose, route, lot number and expiry date were not reported). Concomitant medications were not reported. On 20-OCT-2014, the patient who also was a co-worker of the pharmacist, developed redness and swelling that extended from the injection site past the elbow and down to the hand after receiving PNEUMOVAX 23. The patient felt "ill" after receiving PNEUMOVAX 23 and also stated that the patient had not returned to work since receiving PNEUMOVAX 23 due to he not being recovered yet. The patient was seen by the physician on 20-OCT-2014 when sought medical attention. At the time of the report, the outcome of developed redness and swelling that extended from the injection site past the elbow and down to the hand, felt "ill", the patient had not returned to work was not recovered. Additional information has been requested.
I was supposed to be shadowing floater RPh but due to busy work conditions I tried to help process and administer a Pediatric COVID vaccine.  Due to my inexperience with vaccine processing and administration, i was flustered and did not dilute vaccine before administering to patient.  Mother was notified but we have not heard if there were any serious side effects as of yet.
Chest pain; Palpitation; Everything she tried to eat tasted like metal; Unusual headache; Fever of 102.7; Vomiting until the next day; Did not receive 2nd dose between 25-35 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache), PYREXIA (Fever of 102.7) and VOMITING (Vomiting until the next day). 06-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 06-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose) had resolved. On 07-Jul-2021, VOMITING (Vomiting until the next day) had resolved. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Body temperature: 102.7 (High) 102.7.         No concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received and it contains no new information
mom was w/pt showed pt's arm w/redness & edema in rt deltoid area; c/o soreness suggest cont APAP & apply soaks to rt deltoid area; mom discussed w/MD & ordered peds Advil & soaks to area;
Patient experienced redness, soreness, & swelling at injection site. MD diagnosed as fungal infection due to needle.