chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no taste; no smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste) and ANOSMIA (no smell) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included RANOLAZINE (RANEXA), LISINOPRIL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced AGEUSIA (no taste) and ANOSMIA (no smell). At the time of the report, AGEUSIA (no taste) and ANOSMIA (no smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines not included  Concomitant medicines include Ranolazine, Lisinopril, Blood thinner, Atorvastatin, Baby aspirin Action taken with mRNA-1273 in response to the event was unknown; 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
After both doses of vaccine, I had soreness and swelling in left vas at site of vasectomy.  Pain lasted about one week after each shot. Two weeks after second vaccination, I noticed I could no longer sleep on my left side without pressure in my chest. Pressure increased to pain in right side of chest. Pain would drop away throughout the day, but return at night about an hour and a half after going to bed. Pain continued to get worse over the course of about two months. Exercising with weights made the problem worse. Aerobic exercise did not effect the problem. I was an avid runner before getting vaccinated, but have since reduced my runs to about 3 times a week running about 2-3 miles at a time. At this time after about 7 months, I still have minor pain, but it is very minor. It can still occasionally be a problem lying on my right side. I continue to improve very slowly. I tried using aspirin at the peak of the pain and felt it might have helped a little bit. I have not seen a physician or taken any other medication.
11/15/20: noticed single firm lymph node in left axilla 11/17/20: in the morning found a large focal mosslike area adjacent to left nipple, red, tender to touch 11/18/20: inflamed area in left breaded increased in size, small adjacent focal spots of redness with small vesicles by end of day 11/19/20: new focal area of erythema adjacent to nipple on right breast, also tender, itchy
injection site tenderness, muscle aches, headache, chills, fever 102, nausea Narrative:  Took OTC Tylenol  Other Relevant History:
Pt triaged by RN on 9/16/21 with oversight from Doctor for diffuse popular rash on abdomen, chest and back without shortness of breath and mild throat swelling - Benadryl 50 mg at night, Hydrocortisone Cream 1% twice a day for no more than 3 days after warm showers. Increase intake of water. Apply Bacitracin to any broken areas of skin from scratching. Follow up with provider on 9/20/21 scheduled. Pt advised to seek emergency LOC if rash worsens with any concurrent SOB, worsening swelling of face or throat. He agreed.
Broke out with a rash on 04/08/04. Erythematous macules all over torso, neck and arms, excluded face, hands and feet.  No itching.  Both TM and throat were red (Bilateral OM and Pharyngitis)
Patient returns to the pharmacy after 1 week and shows shingles reaction in the vaccine area including vesicles. Pt. was referred to doctor who specified that it was shingles and prescribed antiviral medications. Patient is doing better but specified that then got the flu.
Hepatitis A was given instead of Hepatitis B. No side effects were reported. Pt was 2 months old.
Per Coroner mom was in bed with baby between pillow and mother on bed. Sheet & blanket in bed. Baby was on side when found. Mom attempted mouth to mouth then drove infant to ED.
Lethargy, fever, swelling above my clavicle, Moderna arm, swelling below my underarm all the way to the side of my left breast. Extensive bruising after swelling went down below my armpit.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 23-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Itching at inoculation site; Redness at inoculation site; Swelling at inoculation site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at inoculation site), VACCINATION SITE ERYTHEMA (Redness at inoculation site) and VACCINATION SITE SWELLING (Swelling at inoculation site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (non reported medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at inoculation site), VACCINATION SITE ERYTHEMA (Redness at inoculation site) and VACCINATION SITE SWELLING (Swelling at inoculation site).   At the time of the report, VACCINATION SITE PRURITUS (Itching at inoculation site), VACCINATION SITE ERYTHEMA (Redness at inoculation site) and VACCINATION SITE SWELLING (Swelling at inoculation site) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Pt devel severe pain, erythema, & induration @ inject site p/receiving Typhoid vax; Pt also devel chills, fever, & h/a;
Initial and follow up information has been received from a pharmacist concerning a 32 year old female with no medical history who on 25-NOV-2006 was vaccinated with a first dose of Pneumovax 23 SC into the left deltoid (Lot # 655054/0749F).  Concomitant therapy included a dose of influenza virus vaccine (unspecified) (lot # AFLUA239AA) administered into the other arm (SC right deltoid) at the same visit (no reaction noted).  On approximately 26-NOV-2006 the patient developed a circular red area and swelling around the injection site (left deltoid) the day after vaccination.  The patient was told to take TYLENOL but the red area spread to a streak (8 to 10 inch line) that extended down her arm.  The patient went to a local urgent care clinic where the physician assistant treating her told her "it was a staph infection from the Pneumovax 23" and prescribed an oral antibiotic.  She was diagnosed with cellulitis and it was reported "given her history and presence of a hematoma this is most likely due to her pneumonia shot injection."  The patient had recovered on an unknown date.  The pharmacist confirmed proper aseptic vaccination technique was used.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   On 04-Nov-2021, the vial was initially stored in the refrigerator. The Vial did not go undergo any temperature excursion. The patient had no any adverse event post administration of expired vaccine.  Treatment information was not provided.
her arm was swollen underneath and red  . the site of the injection was not red, but it was slightly swollen
Besides having a strong reaction, and feeling as if I had COVID for two days after the first shot, I began to have extreme pain in my left breast, in my left underarm, on the left side of my body near my breast, and in my left shoulder blade.  Then, nine days after the first dose I began getting sores on my left breast, left shoulder blade, and under my left arm, on my torso. These  sores are itchy, and very painful. The left side of my body affected by these sores is also tender to the touch, and there also is an pain that will not go away.
2"x3" area of erythema, no induration on RUE where received DTaP and MMR. Treated with Benadryl and oral steroids.
Lip itching- patient took Benadryl and states itching went away. No difficultly breathing, shortness of breath and or wheezing, no hives or low blood pressure.
Day 1: Swollen arm, malaise Day 2: Swollen arm, hives, itching, headache, nausea, diarrhea, aches Day 3:  knot at injection sight.
BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 6/15/2023 Discharge Date: 06/16/2023   DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 74 y.o. female who presented for nausea and vomiting.  At time of presentation, patient appeared confused. Vitals notable for bp 199/68, otherwise unremarkable.  Lab workup was notable for mild leukocytosis with WBC 11.8, platelet 426, potassium 3.1, and patient found to be COVID positive.  Lactic acid, CRP, and troponins were normal.  CT head obtained which showed no acute abnormality.  Chest x-ray with no acute abnormality.  Patient was admitted for further management and workup.   Initially, patient was reporting significant dizziness and nausea, this resolved over time with administration of a scopolamine patch. No focal neurologic symptoms so suspected that dizziness and nausea were likely vestibular in origin. She denied COVID symptoms and it was unclear if finding incidental given exposure 3 weeks prior, no antiviral or steroid initiated.  During admission, she also endorsed recent dyspnea on exertion and chest pain in exam revealed a significant murmur.  Echo obtained which did show mild-to-moderate aortic stenosis, normal ejection fraction.  Stress test obtained which showed no evidence of myocardial ischemia.  At time of discharge, patient's symptoms were much improved.  She was able to work with physical therapy and ambulate independently.  She reported resolution of dizziness and nausea.  She denied any acute recurrence of chest pain or shortness of breath.  Her blood pressures were noted to be fairly soft, 90s/50s, home amlodipine was reduced to 5 mg daily.  She is sent home with scopolamine patch and is instructed to follow up with PCP upon discharge
After my first dose my arm was very sore for about 5 days. That was my only symptom for the first dose. The second dose has been terrible. I woke up the day after my second dose and I have never felt like that before. I was so sick, dizzy, nauseous, shaky, headache, body aches, fever, and chills. And my arm was red, itchy, swollen, and super painful. I felt like I needed to puke all day long and my body just ached all over. I also had this weird problem with my left foot. It felt like I had been sitting on it but I hadn't. It ached and I kept getting muscle spasms. I felt a little better as the night went on but still had a really bad headache. Today I feel much better but my arm is way worse today. I have a huge welt and bumps all over the injection site. It's very very painful and hot to the touch. It itches so bad but good thing it's hurting because at least it's preventing me from scratching it.
Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-24.
Headache, Injection site knot, fatigue, body aches Narrative: states: raised hard lump the size of her palm which has improving daily- the site is a "knot" warm, and reddened no fever but felt hot and cold the evening after the injection
Extreme pain in left shoulder (painful to the touch as well as chronic deep pain), heat at injection site, fever, body aches, headache, sweating, congestion Treated with Extra Strength Tylenol
hurting underneath her armpit; diarrhea; swelling; redness going down arm; vomit; low-grade fever; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hurting underneath her armpit), DIARRHOEA (diarrhea), SWELLING (swelling), INJECTION SITE PAIN (Pain at injection site) and INJECTION SITE ERYTHEMA (redness going down arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Stroke (5 years ago). Concurrent medical conditions included Drug allergy (Allergies include penicillin, aspirin, codeine, and Lasix). Concomitant products included ADALIMUMAB (HUMIRA), METOPROLOL SUCCINATE (TOPROL), LANSOPRAZOLE (PREVACID), PREGABALIN (LYRICA) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (hurting underneath her armpit), DIARRHOEA (diarrhea), SWELLING (swelling), INJECTION SITE ERYTHEMA (redness going down arm), VOMITING (vomit) and PYREXIA (low-grade fever). At the time of the report, PAIN IN EXTREMITY (hurting underneath her armpit), DIARRHOEA (diarrhea), SWELLING (swelling), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (redness going down arm), VOMITING (vomit) and PYREXIA (low-grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact.
within 1hr p/vax pt devel severe nausea, fever & trembling;taken to ER; pt on ventilator;
Pt called event coordinator that they were experiencing symptoms 3 hours post vaccination. Complaint of shoulder pain radiating to neck area, difficulty breathing, sharp chest pain, lightheaded. Patient stated that she had lunch after vaccination. Complained of "tightness" in neck area. Spoke to patient on phone and assessed as much as possible. When patient mentioned difficulty of breathing, patient was advised to go to ER. Patient stated she was on the way.  At ER, EKG was done and patient was awaiting to be seen. Chest xray was done. BP was lower than usual and blood sugar "spiked up" - 340s according to patient. ER hydrated patient and blood sugar resolved to 140s.  04/05 Patient was checked on. She has fully recovered.
2-3 weeks post vax the pt developed a rash focused on her face, under her eyes, by the ears, and on her scalp. It was reported that the symptoms were still prominent and getting worse. The pt sought unspecified medical attention. No further information is available.
Awaken at night with very sore arm and a headache.  Took a 500mg Tylenol and was able to go back to sleep.  Headache resolved the next morning.  Sore arm resolved in about 2 days
Hives, redness, swelling of upper chest and shoulders and neck.  Throat closing and loss of voice when throat severe.
fainted; This is a spontaneous report from a contactable consumer (patient). A 28 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 28Mar2021 (at the age of 27 years old) as a single dose for covid-19 immunization. The patient's medical history was not reported.  Patient was not pregnant at the time of vaccination and the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies of any kind. The patient had no concomitant medications. Patient was not taking any medications/supplements. Patient had no other vaccine in four weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was in a pharmacy or drug store. Patient fainted on an unspecified date in 2021 after her first dose. No treatment was received in response to the event. Since the vaccination, the patient was not tested for COVID-19. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Vomiting, fever (as high as 101 degF), chills, pale complexion, fussy, low energy. Resolved the next day.
Severe Headache, body aches, chills, fatigue, and metallic taste in mouth
itchy 1" x 2" red warm area around injection site noted this a.m. School nurse circled area and sent patient for exam, the borders of red had decreased in size since being circled.
Redness (circumference about 2cm) which started 24 hours, post vax.
Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications were reported.  The patient administered the Moderna COVID-19 vaccine which was stored in freezer for which temperature was not monitor. The site had a data logger, but it was not set up to record. The health care professional (HCP) stated there was no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. Therefore, it was unknown if a freezer temperature excursion actually occurred.  The event potential sub potent dose did not cause patient to seek medical care.  There were no adverse events reported. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow up received quality complaint number added.
Muscles and joint aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2021 11:00 (Lot number: EL9263) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EL3247, Anatomical site of injection: Right arm, Administration date: 27Jan2021, Administration time: 11:00 AM), administration date: 27Jan2021, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Muscles and joint aches".  Additional information: Drug Lot Number and Expiration Date: 3rd: 30130BA. Dose: 3rd. Date: 24Aug2021. Time: 10:00 AM. Anatomical site of injection: Right Arm. Relevant test: None. Specific Relevant Test for Thromboembolic events with Thrombocytopenia was reported as None. Adverse Events: AE term: 6 days. Onset date: 24Aug2021. Onset time: 11pm. Seriousness criteria: Not serious. AE outcome: Recovered. Background  2nd shot, The patient had 12 hours of muscle and joint aches. Booster  The patient started with muscle and joint aches about 12 hours after shot. Took Tylenol. 25Aug- moderate- severe joint muscle aches all day took Tylenol. 26Aug- Awoke with severe neck and all over headache took tyenol- plus The patient had joint pain. Felt like head is nice. 27Aug- Still painful headache, joint pain a little better , took adirl. 28Aug-30Aug  Pain lessered each day , took adirl until the 29th.   No follow-up attempts are possible. No further information is expected.
Mother describes "shaking left leg followed by shaking all over." Evaluated at ER- no neurological deficits noted.
Covid arm rash appeared about 1 week after injection and lasted for about a week.  About six inches in diameter
5x2.5cm local reaction at vaccine site on R thigh. Firm, erythematous, warm to touch, slightly tender to palpation, well defined.