chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sinus issues; Sore throat; Did not feel well for two days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well for two days), OROPHARYNGEAL PAIN (Sore throat) and PARANASAL SINUS DISCOMFORT (Sinus issues) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MALAISE (Did not feel well for two days). On 01-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (Sinus issues). On 29-Jan-2021, MALAISE (Did not feel well for two days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PARANASAL SINUS DISCOMFORT (Sinus issues) outcome was unknown.            No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I started feeling lumps in my left leg which progressively got worse. It was between my middle thigh and middle 2 days later I started to feel it in my right leg. The left leg was more intense and very painful. I went to the vascular surgeon who put me on regular aspirin, and I did an ultrasound on December 07, 2022. They confirmed that there was a superficial blood clot there. They wanted me to stay on a daily dose of aspirin. They did another ultrasound 1 week later. They saw that they were starting to dissolve. They had me switch to baby aspirin 1 a day. By the end of the 3rd week of December, they were pretty much back to normal.
The next morning after my vaccination, 01/30/2021, I had chills, fever, body aches, feeling of complete exhaustion, loss of appetite. I felt like I couldn't walk across the room and I didn't get out of bed for 24 hrs. It was 02/01/2021 when I stated to see blisters on my waistline, horizontal across my waist, on the front right side. About 8 or 10 inches long, a stripe of shingles. I went to see my doctor on 02/03/2021 and she confirmed that I had shingles. No medications were prescribed. The rash/shingles lasted about 2 weeks.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-JAN-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 1 (dose unknown), from lot # H018451 with expiry date of 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination.  Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days.  The patient is now feeling fine, all events have improved.  She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition.  She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report.  No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.
Pleurisy; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PLEURISY (Pleurisy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PLEURISY (Pleurisy). At the time of the report, COVID-19 (COVID-19) and PLEURISY (Pleurisy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of pleurisy, COVID-19 was assessed as reasonable possibility for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow-up received includes: New event(pleurisy) added.
Noticed on 7/30/12. Patient noticed 8cm redness at injection site and about 3cm area of raised blisters. Advised patient to take oral BENADRYL and use hydrocortisone cream. Patient also described intense itching at the area. Advised patient to follow up with MD if SX persist > 1 day.
Breakthrough case admission after 4 vaccines Pfizer 3/5/21 Lot# EN6199;  Pfizer 3/26/21 Lot# Ep7534;  Pfizer 12/3/21 lot# EW0179;  Pfizer 8/24/22 Lot# FP7139
6 doses were administered to patients from a vial that expired 3 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses were administered to patients from a vial that expired 3 days ago) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses were administered to patients from a vial that expired 3 days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses were administered to patients from a vial that expired 3 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Reporter stated that patient received his first dose (lot number 011A21A ) of Moderna COVID19 Vaccine on 08Mar2021 in his right deltoid. He received his second dose (lot number 007B21A ) on 08Apr2021 in his left deltoid.   The pharmacist confirmed that the patient was immunocompromised No Concomitant Medications details were provided.  No Treatment Medications details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up includes patient information
Rash- about 4" diameter at injection site for 2-3 days after injection. Developed generalized aching on 3rd day after injection; lasted 2 days. Some relief with ibuprofen. No visits to a physician.
Acute venous dural sinus thrombosis. Started on argatroban drip.  Discharged on eliquis.  Found to have left temporal stroke and venous infarct in left temporal lobe
I started having shortness of breath and it kept getting worse.  I went to the Emergency room several times until 6/18 that I was diagnosed with Congestive Heart Failure
Patient reported adverse event on 11/10/2022. Patient complains of pain in arm and limited mobility
patient became pale and stated she was not feeling well and fainted immediately after receiving the vaccine.  Patient regained consciousness immediately and was alert and oriented x 3.  Recovered and was well enough to leave the clinic on her own.
A non-serious spontaneous report of '29 patients received expired FLUMIST" was received from a physician concerning a five-year-old male. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Email received in the Mailbox on 16JUN2023 at 3:58pm from a Merck employee reporting an adverse event for GARDASIL reported via website. Some fields marked "unknown" as they were unable to be asked. No letter sent as no consumer/physician dem; Wrong vaccine administered; This spontaneous, Social-Media report was received from a consumer refers to a 32-year-old female patient. The patient's medical history, concurrent conditions were not reported. The concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP).  On 16-JUN-2023, the patient was accidentally vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the 32 weeks pregnant patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) because someone put the vaccine in the wrong place in the fridge (exposure during pregnancy, wrong product administered).
Fever Aches Headache Stomach ache Muscle cramps Swollen lymph node in arm pit
pt presented to hosp ER w/weakness that progressed from legs to upper body on 3SEP96;
Patient fainted about 10 minutes after receiving first dose of Covid-19 vaccine.  She was instructed to remain seated in the waiting  room but got up and walked around the store with her parents and felt faint after walking for a minute or two.  She passed out and was caught by her dad and gently laid down on the floor.  Paramedics were called to check vitals as patient continued to feel drowsy for a few minutes.  She was assessed by paramedics and released to parents after checking vitals, blood glucose, heart.  She stated she was feeling better after several minutes of sitting or laying down.
I got shot and I got shingles but a mild case / Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles but a mild case. The patient stated that shots did not prevent shingles, it might cause it to be a milder case. The patient stated that she wished they would stop making it sound false, like if you get the shot you would not get shingles.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR106775, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106775:same reporter (husband case)
This spontanoeus report as received from a health care professional refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. The reporter stated that doses of COMVAX (dose, route, lot number and expiry date were not reported), which were exposed to temperatures outside of the recommended range on 12-JAN-2015, had been administered to unspecified patients on unspecified dates since 12-JAN-2015. No adverse experienced was reported. Additional infromation has been requested.
Information has been received from a physician concerning a five yr old male pt who in approx 2002 was vaccinated with varicella virus vaccine live. The physician reported that the pt came into the office yesterday, 12Jan06 with flu-like symptoms and vomiting. The physician noticed a bad rash on one of his legs that looked like zoster. It was reported that the physician mentioned the pt now has herpes zoster. No further information is available regarding the event or the pt's outcome. There was no product quality complaint reported. Additional information has been requested.
Red rash on upper left arm near injection site.  Rash is oval in shape and approximately 3.5 inches x 2.5 inches.  It was initially itchy.
Severe headache, fever of 103.9, tachycardia, lymphadenopathy, body aches, chills, fatigue, and shortness of breath. Advised to go to Urgent Care on 1/14/2021. Was given fluids and toradol and told to continue to monitor and treat symptoms at home.
Patient fell in her garage; Dislocated shoulder; This spontaneous case was reported by a patient and describes the occurrence of FALL (Patient fell in her garage) and JOINT DISLOCATION (Dislocated shoulder) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 028L20A, 014M20A and 051E21A) for COVID-19 prophylaxis.     The patient's past medical history included Ischemic stroke (mild) in 2014. Concurrent medical conditions included Multiple sclerosis and Lupus anticoagulant hypoprothrombinemia syndrome (Lupus Anticoagulant Disorder). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], CLONAZEPAM, PREGABALIN (LYRICA), VITAMIN B12 [VITAMIN B12 NOS], COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL) and CLONAZEPAM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2022, the patient experienced FALL (Patient fell in her garage) and JOINT DISLOCATION (Dislocated shoulder). At the time of the report, FALL (Patient fell in her garage) and JOINT DISLOCATION (Dislocated shoulder) outcome was unknown.            Other concomitant medications included Excedin as needed. No treatment information was provided.   This case was linked to MOD-2022-661319 (Patient Link).
Redness @ injection site 8-10cm, fever, erythema, urticaria and induration.  Treated with benadryl and tylenol.  Duration period was 11/6/99 - 11/9/99.
Hospitalization for acute hypoxemic respiratory failure with pneumonia secondary to COVID-19 on dates 10/28/2023- 11/3/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Cold chills, headache, muscle ache, joint ache, nausea, and extreme tiredness
Myocardial Infarction. I'm on many meds now. Spike protein in vaccine caused my right coronary artery to clot. Then clot caused lesion in artery leading to MI. Was shocked in catheterization lab.
Patient was tired for the next 3 days and then on the third day started having trouble speaking.  He knew what he wanted to say but had a very difficult time speaking.  In the patient's words "my speech sounded very sticky and stuttering".  The patient also stated that he felt like his brain was not working quite right and that he was having to expand tremendous amounts of energy to get words out.  This problem has improved dramatically.  I spoke with patient and his wife today, 10/28/2022, and he feels like he is 75% improved.  He is working with a speech therapist.  Patient saw his neurologist October 18, 2022.  She felt the patient was having some "neurogenic stuttering".  Patient has been seen neurologist related to long COVID symptoms which preceded this flu vaccination.
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
Warm, Red, Induration->upper (L) arm 5 1/2" x 4". Denies Pain- (1) Ice packs (2) Ibuprofen 3 tsp Children every 6 hours by mouth. Return if sx increase.
UriticariaPruritus, NauseaVomiting, Pain and difficulty moving left arm, fatigue
Nurse injected vaccine into arm without stabilizing arm, injection was started and patient moved arm away.  Patient had to be re-stuck to administer vaccine.
This spontaneous report as received from a healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored PNEUMOVAX 23 may have all been administered. The healthcare worker that she would call back once she knows for sure which vaccines had been administered. The healthcare worker reported that the PNEUMOVAX 23 was exposed to a temperature of 1.5C for 25 minutes. No adverse effect reported. Additional information has been requested. These are one (1) of five (5) reports from the same reporter. (MARSS 1405USA012173, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571).
1st adverse event: was chest congestion with bad coughing and hard time breathing. Called 08/26/21 to clinic, prescribed over the phone high dose of prednisone for 2 weeks. Within 2 weeks after, started having muscle cramps, painful muscle tightening and stiffness all over my body. Had very hard time working. Saw another doctor, after blood test, found out that I had high c-reactive protein level at 70.8, sedimentation level at 48, then was referred to the rheumatology dept. at clinic. After many more blood test, Ct's, X-rays, I was diagnosed with Polymyalgia Rheumatica.
This spontaneous report was received from a registered nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # K023363, expiration date: 20-MAY-2016 and lot# K023364, expiration date: 20-MAY-2016) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of PROQUAD (Merck) experienced the temperature excursion of -6.5 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. The previous temperature excursions were -7.4 degrees Celsius for 2 hours and 36 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
WEAKNESS, NAUSEA, VOMITING, SYNCOPE WITH URINARY INCONTINENCE.  DESCRIBED FEELING WEAK AND NOT GOOD BEING UP EVERY HOUR WITH NAUSEA. WOKE UP AT 7AM, VOMITED AND PASSED OUT ON BATHROOM FLOOR WITH INCONTINENCE OF URINE.  ROOMMATE DESCRIBED SEIZURE LIKE ACTIVITY WHILE PT WAS ON THE FLOOR. PALLOR. DIZZINESS. PT GIVEN 1L NS, CT SCAN AND LABS.
Severe pain in left arm / shoulder for 3 days. 9 days later a red silver dollar sized circle appeared at vaccination injection site.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
Over a 2 hour period a headache on the left portion of my head began to increase in pain. It went from my left temple to my right temple and then the pressure traveled to areas behind my ears. Additionally, I had sensitivity to light along with the headache and I began feeling nauseous. The headache, dizziness, and nausea led to vomiting a few times over a 30 minute period. I went to the Emergency room and I was treated for my nausea with ZOFRAN and an hour after that medication I was able to take MOTRIN.