chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt "hypothermic"; freezing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (felt "hypothermic") in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Menopause since an unknown date. Concomitant products included BIOTIN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced HYPOTHERMIA (felt "hypothermic") (seriousness criterion medically significant) and FEELING COLD (freezing). At the time of the report, HYPOTHERMIA (felt "hypothermic") and FEELING COLD (freezing) outcome was unknown.            Patient takes Estrovera (dietary supplement) concomitantly. No treatment medications were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-081823 (E2B Linked Report). This case was linked to MOD-2021-090525 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-081823:another product (pfizer )
Red, hot & swollen area size of softball at injection site, much larger than previous injections. Lethargy, fever, general flu-like feeling on days 2-3 after injection. On Day 4, fainted twice. The first was while I was home alone getting ready for work in the morning- I woke up 2 1/2 hours later when my employer called to check on me because I was absent from work. The second fainting spell was at about 9:00 pm that night while I was walking from one room to another- I fainted and fell in the hallway and injured my neck when my head hit the wall on the way to the ground.  I woke up almost immediately that time, but was very light headed and had to rest afterward. My neck required therapy for a few months afterward.  The lethargy lingered for  a few months, and my employer insisted that I take time of work to rest over the next few months.  I missed a total of 5 half days of work in total.
1130 MENACTRA vaccine administered (L) deltoid IM - Pt tol well denies any complaint. 1145 pt ambulated by self out of office with mom in attendance. 1145 pt found sitting in elevator weak, lightheaded and diaphoretic Bp=114/60. 1150 pt moved to laying down position. Blood sugar = 88 - PO fluid offered pt A + O x 3. 1155 Pt remains laying down BP = 106/64 Pulse ox = 98 pulse = 62.Pt to sitting position 1210 pt "feeling better" Bp = 104/62 pulse ox = 99 pulse = 62. 1215 pt to home with mother.
NO ADVERSE REACTION S/P COVID-19 BOOSTER VACCINE SHOT.  I'M REPORTING AS A PRECAUTION AS A HEALTHCARE PROVIDER IN A LONG-TERM CARE FACILITY.  I WILL DESCRIBE THE EVENTS: RECEIVED BOOSTER VACCINE 1/28/22 AT 10:30AM AT AHCF.  FACILITY COMPLETED Q SHIFT S/P VACCINE ASSESSEMNTS.  NO NEGATIVE FINDINGS UNTIL 1/29/22 ON 3-11 SHIFT AT APPROX. 1600 PER NURSES NOTES, FATIGUE, DECREASE LOC, DIMINISHED LUNG SOUNDS, AND RAPID/SHALLOW BREATHING. PHYSICIAN NOTIFIED AND SENT TO ER VIA AMBULANCE.  ADMITTING HOSPITAL DX: HEALTHCARE AQUIRED PNEUMONIA, HYPERNATREMIA.  THE NURSE MADE ADMITTING HOSPITAL AWARE THAT RESIDENT HAD RECEIVED BOOSTER SHOT ON 1/28/22.  THE HOSPITAL RECORDS DO REFLECT THIS.  THIS NURSE SPOKE the HCF NURSE ON 1/31/22 AND I ASKED HER IF THE PHYSICIAN FELT THE BOOSTER VACCINE CAUSED THE HOSPITALIZATION AND SHE NO.  THE RESIDENT HAD A RECENT HOSPITAL STAY AT another HCF 1/7/22-1/11/22 DX: AMS, ENCEPHALOPATHY, ELEVATION OF LEVELS OF LIVER TRANSAMINASE LEVELS, DISORDERS OF BILIRUBIN METABOLISM, POTIENTIAL STROKE, UNSPECIFIED CONVULSIONS.  CHEST X-RAY DONE AT NARMC LLL PNEUMONIA AND SODIUM LEVEL 150 ON ADMIT 1/29/22.  I WAS NOT SURE IF THIS NEEDED TO BE REPORTED SINCE HE HAD TO GO TO THE HOSPITAL 1 DAY AFTER RECEIVING THE BOOSTER SHOT EVEN IF DIAGNOSIS WAS UNRELATED.  RESIDENT DID NOT PASS.  I WANT TO MAKE NOTE THAT I HAVE TRIED TO SEND THIS ELECTRONICALLY SINCE 2/1/22 AND FAX 2/2/22 AND 2/3/22 AND 2/4/22 WITHOUT SUCCESS.  IT WILL NOT GO THROUGH.
w/in 4wk devel unexplained papular erythematous rash, reminiscent but not typical for varicella infect
the pain in the arm increased; minimum stomach side effects; some chills; headache; she had pink skin and rash; it was swollen; tenderness at the injection site; it was a little painful; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE PAIN (it was a little painful), PAIN (the pain in the arm increased), ABDOMINAL DISCOMFORT (minimum stomach side effects) and CHILLS (some chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE PAIN (it was a little painful). On 30-Mar-2021, the patient experienced PAIN (the pain in the arm increased), ABDOMINAL DISCOMFORT (minimum stomach side effects), CHILLS (some chills), HEADACHE (headache), PHOTOSENSITIVITY REACTION (she had pink skin and rash) and PERIPHERAL SWELLING (it was swollen). On 31-Mar-2021, ABDOMINAL DISCOMFORT (minimum stomach side effects), CHILLS (some chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE PAIN (it was a little painful), PAIN (the pain in the arm increased), PHOTOSENSITIVITY REACTION (she had pink skin and rash) and PERIPHERAL SWELLING (it was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Moderna COVID-19 Vaccine EUA. Patient reported pain in left eye after covid vaccine. Patient noted to have elevated BP and redness/subconjunctival hemorrhage in left eye. persistent HTN. Allergist notified and Patient instructed to go to Emergency Dept. for further evaluation.
When I got the vaccine I fainted. I never fainted before with vaccines. The real problem started a week after I got the vaccine I felt extremely exhausted, and I'm  having  a hard time getting up from bed in the morning.   My symptom is that all my  joint hurt so much, my ankles, my wrist,  my knees, my hips , my elbows anywhere is a joint its hurts.  If im sitting it hurts, if I'm standing it hurts, if im laying down it hurts.  Besides that I feel nervous, like I'm shaking in the inside, but I'm not shaking.
Patient noticed soreness at injection site, then warmth & redness followed. PCM put patient on AUGMENTIN 500mg 1 tab twice daily for 5 days, MOTRIN 600mg 1 tab by mouth every 6 hours for pain. Follow up appt in 2 days.
09:14 -noted by this RN to be grimacing and slowly rubbing sternum. Approached patient and assessed with the help of an interpreter and patient's daughter. Pt reported 8/10 sternal chest pain that felt like an electric shock. 09:15-EMS called.  Pt VS: 130/88, HR 80, oxygen saturation 96% on RA. Breathing pattern shallow and tachypneic. No diaphoresis or pallor noted. 2L oxygen via mask delivery administered to patient for MI intervention. 81 mg chewable asa also administered. 09:20-EMS arrived on scene.  Pt reports complete resolution of pain at this point. Pt assessed by EMT with VS: 149/88, HR 78, O2 sat 94-95% on RA (pt removed O2 mask to take asa). Transport to hospital for further evaluation offered to patient and family; offer declined. 09:39-EMS departed scene. 09:45-patient and family departed scene for home with instructions to call 911 if symptoms reappeared, and to follow up with cardiologist for possible pacer interrogation.
VERY sore joint (couldn?t walk using my knees).  Very exhausted, migraine headache and slight nausea.
next morning he woke up deaf in his right ear./still cannot hear in his right ear; fatigued for a few hours after second shot; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (next morning he woke up deaf in his right ear./still cannot hear in his right ear) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigued for a few hours after second shot). On 13-Mar-2021, the patient experienced DEAFNESS UNILATERAL (next morning he woke up deaf in his right ear./still cannot hear in his right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (next morning he woke up deaf in his right ear./still cannot hear in his right ear) had not resolved and FATIGUE (fatigued for a few hours after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment This case concerns a 45-year-old male patient with no relevant medical history, who experienced serious unexpected event of deafness unilateral with another non-serious event. The event occurred the day after the second dose of the mRNA-1273. The rechallenge was not applicable as the events occurred following the second dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 45-year-old male patient with no relevant medical history, who experienced serious unexpected event of deafness unilateral with another non-serious event. The event occurred the day after the second dose of the mRNA-1273. The rechallenge was not applicable as the events occurred following the second dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient inadvertently received both of the above-mentioned vaccines concurrently as a result of an physician-ordering miscommunication.  The mother of the patient was notified by phone by the ordering physician, and there have been no reported adverse reactions or side effects.
Got my vaccine. / about kilt me; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated that he/she got Shingles vaccine and the second one about kilt him/her. The patient stated that still glad he/she got it. The follow-up would not possible as no contact details were available.
Began having swallowing issues, talking issues, weakness, breathing problems, droopy eyelid. The symptoms started out with her feeling tired and weak not long after the shot. By April and may she started having difficulties with swallowing and she started to fall down. I began calling doctors in may and struggled to get appointments with specialists. A pediatric neurologist didn't diagnose anything. It was a neurologist who ordered more testing. He sent her to the facility on July 14, 2010. Patient was diagnosed with Myasthenia Gravis at the age of 14.
GUILLAIN-BARRE Syndrome - Infusion/Hospitalization. CIPD- Infusions / EMG. -Twitching. Spasms, Numbness, hyperesthesia, Chest pain. Choking/Smothering sensation, hyperventilation, SOB, Tachycardia, Lightheadedness, Paresthesia.
nausea; around the area of the mouth and above it there was a burning sensation; not feeling good; This is a spontaneous report from a contactable consumer or other non hcp (Patient).     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea, around the area of the mouth and above it there was a burning sensation, felt quesey and not feeling good. She felt quesey as she was sleeping and was nauseated, thought maybe she was dreaming being nauseated. She took some Tums, then she didn't remember if she had actually took the Tums, then she recalled she did in fact take the Tums. Right before she woke up, she was not feeling good, then when her alarm went off and said she felt fine. She said she was going to eat 'Gingerly' so to prevent nausea. She told she watched what she ate and must need to eat carefully that day. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route were unknown). No concomitant therapy was reported. On an unknown date (reported as "several months ago") the patient experienced rash. The rash had scabbed over and was healing up when the patient came into the pharmacy several months ago. This is one several reports received from the same reporter. Additional information has been requested.
Diarrhea; Injection site painful after covid 19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site painful after covid 19 vaccination) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Stomach cramps and Stomach pain.   On 21-Mar-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site painful after covid 19 vaccination). At the time of the report, DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site painful after covid 19 vaccination) had resolved.     No concomitant medication information was reported. No treatment medication information was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
little red rash all over face; little red rash all over face; This is a spontaneous report from a contactable consumer or other non-hcp. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 17-year) on 28Apr2021 as dose 2, single for COVID-19 immunization; patient received paroxetine, an antidepressant type drug (Batch/Lot number: unknown; Expiration date: unknown) via an unspecified route of administration from 28Apr2021 to 28Apr2021, at unspecified dose for depression. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On 28Apr2021 the patient experienced little red rash all over face. It was reported that "caller, (Name), was calling on behalf of her granddaughter (Name), 17 years old who received her 2nd dose yesterday (28April). Caller said that her granddaughter took Paroxetine, an antidepressant type drug yesterday however she had a little red rash all over face. Caller was asking if the vaccine interacts with the Paroxetine that she took." The action taken in response to the events for paroxetine was unknown. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approx. 24 hrs after vaccine, had symptoms that included fever, diarrhea, dizziness, weakness, fatigue, nausea.
Patient described mosquito bite type bumps starting in the arm near the injection site.  Then, rash migrated up through the shoulder and started hitting all over the trunk and legs.  Did not stay on one side like actual shingles typically does. Patient has resolution of itching symptoms but rash still persists at this time.
face and abdomen felt like when you get contrast dye with a CT; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 13:00 (Lot number: EN6198) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ocular rosacea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Sinus" (unspecified if ongoing), notes: Sinus; "allergies: Penicillin/ allergic to Penicillin" (unspecified if ongoing), notes: allergies: Penicillin/ allergic to Penicillin; "allergies: Yellow Dye #5/ allergic reaction" (unspecified if ongoing), notes: allergies: Yellow Dye #5/ allergic reaction 10 years ago with Yellow Dye 5; "Dermatomyositis" (unspecified if ongoing), notes: Diagnosed after an allergic reaction 10 years ago with Yellow Dye 5 on a low dose Aspirin regimen. Concomitant medication(s) included: LIVALO; ASMANEX; NASOCORT; SINGULAIR; AZELA; AREDS. Past drug history included: Aspirin, reaction(s): "allergies: Aspirin", notes: allergies: Aspirin; Ceclor, reaction(s): "allergies: Ceclor", notes: allergies: Ceclor; Lumify, reaction(s): "allergies: Brimonidine Tartrate/ allergic to Brimonidine Tartrate (Lumify)", notes: allergies: Brimonidine Tartrate/ allergic to Brimonidine Tartrate (Lumify). The following information was reported: SKIN DISORDER (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "face and abdomen felt like when you get contrast dye with a CT". Therapeutic measures were not taken as a result of skin disorder.  Additional information: With her first dose her face and abdomen felt like when you get contrast dye with a CT. lasted 5 minutes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Other. The patient received second dose of Pfizer covid vaccine on 22Mar2021 13:00 (lot number: EN6502) administered in right arm.  No follow-up attempts are possible. No further information is expected.
Both shot were given in left arm due to polio in the past. Her whole upper arm was swollen and red and painful. She saw a dr. who prescribed a pain medication and cephalexin incase the her arm gets worse
Moderna Rash again that looks like cellulitis but isn't.  Red itchy rash from shoulder to elbow stating day after vax; headache immediately after injection; fever evening of day 2; general lethargy and overall body aches 10X usual aches.  Rash is still on-going but improving on this day 6.
pt recv vax & 2DEC97 pt exp a varicella-like rash w/21 to 25 lesions;
Patient developed itchy red spot, developed blister and spread to four-five bumps that was oozing, patient saw doctor and was prescribed an antibiotic.
It may have begun earlier but I didn't notice until the above day and time. I have a warm, red welt at the injection site.
Patient received vaccination, proceeded to do some shopping, felt lightheaded so he sat down in the grocery department, was able to walk to the pharmacy saying he still felt lightheaded and had pressure in the back of his head. Had patient sit down right in front of the pharmacy cashier, had him sip some water. Pharmacy management was notified and offered an ambulance but he refused. Patient sat for 30 minutes and had a family member come to take him home. (unclear if medical attention was needed) Tried to follow-up with patient, but had to leave a voice message
CLIENT PRESENTED BACK TO CLINIC 45 MINUTES AFTER VACCINATION FEELING ANXIOUS AND DIZZY.  RR 18-20 UNLABORED, HR 120 REGULAR, BP 128/62.  BENADRYL 25MG PO GIVEN @ 11:05AM.  POSITIONED IN A RECLINED POSITION AND MONITORED VS Q 5 MIN FOR 30MIN AND VS REMAINED STABLE.  CLIENT ALSO SHARED SHE RECENTLY D/C'D HER ANXIETY MEDICATIONS AND HAS BEEN OFF OF THEM FOR 3 WEEKS.  CLIENT SAT UPRIGHT AFTER 30 MINUTES .  NO FURTHER DIZZINESS, VSS, COLOR GOOD.  CLIENT REPORTS FEELING BETTER AND WAS DISCHARGED WITH A DRIVER.  FOLLOW UP CALL AT 12:30 AND THE CLIENT REPORTED SHE WAS FEELING "BACK TO NORMAL".