chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever; Headache; Sick; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomited) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced ILLNESS (Sick) and VOMITING (Vomited). On 21-Mar-2021 at 3:00 AM, the patient experienced HEADACHE (Headache). On 21-Mar-2021 at 10:00 AM, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Mar-2021, ILLNESS (Sick) and VOMITING (Vomited) had resolved. On 21-Mar-2021 at 1:00 PM, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 22-Mar-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified Statins for cholesterol.
Fall; Patient is potentially receiving the second dose of the vaccine more than 36 days after the first dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FALL (Fall) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039R20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Alzheimer's disease and Behaviour disorder. Concomitant products included MEMANTINE for Alzheimer's disease, ALLOPURINOL for Gout, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, VITAMIN D [VITAMIN D NOS] for Vitamin D deficiency, OLANZAPINE (ZYPREXA), MELATONIN, CALCIUM, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM;ERGOCALCIFEROL]) and FERROUS SULFATE for an unknown indication.   On 10-Feb-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (Fall) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is potentially receiving the second dose of the vaccine more than 36 days after the first dose). At the time of the report, FALL (Fall) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is potentially receiving the second dose of the vaccine more than 36 days after the first dose) had resolved.            No Treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Telephone follow-up received. Daughter reported patient received second dose. Daughter also reported father was hospitalized due to fall at nursing home unrelated to vaccine. Declined further follow-up.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #   039R20A with  associated Adverse Event of Fall .Very limited information regarding this event has been provided at this time.  Further information has been requested.
This is a serious observational study case, initially received from other health professional on 12-Feb-2019, concerning a 35-year-old adult female pregnant subject of body weight: 195 lbs, height: 67 inches and body mass index (BMI): 30.5 enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had 3 previous pregnancy in which 2 were live birth and 1 was spontaneous abortion. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's current conditions included nausea and vomiting. The subject's concomitant medications included Prenatal Vitamins (minerals nos, vitamins nos) for pregnancy and Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea and vomiting. The subject's last menstrual period (LMP) date was 12-Aug-2018. The type of pregnancy was singleton. On 24-Sep-2018, the subject underwent haemoglobin electrophoresis, spinal muscular atrophy and fibrosis mutation analysis and no major congenital malformation was noted. On 02-Oct-2018, at gestational age of 7 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On the same day, after vaccination, the subject experienced Sub-chorionic hematoma/hemorrhage (SCH) for 3 times (reported as pregnancy complication). On 02-Oct-2018, the subject underwent ultrasound and no major congenital malformation was noted. On 30-Nov-2018, the subject underwent Q-natal (pre-natal screening) and no major congenital malformation was noted. The subject's estimated delivery date (EDD) was reported as 08-May-2019. The outcome of the event was not reported.; Reporter's Comments: A 35-year-old pregnant subject with gestational history (2 live birth and 1 spontaneous abortion) experienced sub-chorionic hematoma/hemorrhage for 3 times, on the same day after administration of study vaccine at 07 weeks of gestation (coded to Exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event and lack of evidence for a biological mechanism that could cause the event and risk factors (advanced age and gestational history), the event was assessed as not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
The patient received DTAP/IPV but not the ActHIB, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 1 year old male patient who received DTAP/IPV but not the ACTHIB part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE for prophylactic vaccination.  On 02-Sep-2020, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6736AA, expiry date: 21-Jun-2022, Single dose Vial) (Frequency: 2nd) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  The nurse reported that a medical assistant went to administer Pentacel, however thought she mixed the dilutent with the powder when she actually had not. It was an oversight error.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No additional AE information reported; expired MMR II vaccine, which expired on March 26, 2022 was administered to a patient on April 7, 2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 07-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 0.5 milliliter (reported as .5 mL), lot #T010650, expiration date 26-MAR-2022 (strength, and route of administration were not provided), for prophylaxis (expired product administered). No additional adverse event (AE) information reported.
None Stated  3/24/09 Received hospital medical records or 11/6-11/9/2008. FINAL DX: cellulitis of left arm s/p immunizations Records reveal patient experienced swelling, redness, vesicles & induration of LUE.  Had been seen in Er on 11/5, dx w/cellulitis & started on oral antibiotics.  Condition worsened & admitted.  Tx w/IV antibiotics w/significant improvement.  D/C to home on continued oral antibiotics.
pt recvd vax & cried holding breath; pt turned pale; cyanosis of lips, mouth area;
Burning from injection that subsided within 10 minutes, very sore upper arm pain for 3-4days,   knee joint pain with burning sensation started 24 hours after injection and still present. Calf pain 6 days after and is intermittent.  Mild fever 24 hours after subsided within 12 hours.
Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022; administered vaccines past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  Reportedly, the by used date was mentioned as 24-Apr-2022. The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box. On 27-Apr-2022, the vaccine was removed from the Fridge.  No treatment information was provided.
fever; pain / exceptionally sore; incredible headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, pain and headache. On an unknown date, the outcome of the fever, pain and headache were unknown.   It was unknown if the reporter considered the fever, pain and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-NOV-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had the 2nd dose of Shingles vaccie 1 day prior to the day of reporting.  The patient was realized everyone's different, fever, pain, incredible headache and exceptionally sore. However, he or she would do it again to avoid what happened to some of the previous posters. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Patient pain in arm at injection site next day after receiving 1st dose; Patient noticed swollen shoulder in arm at injection site; She slept all day.; burning pain all over body; Abdomen was swollen; Right side of her stomach (underneath breast) had some rash; Patient feels like having symptoms of fibromyalgia; Right side of her stomach (underneath breast)was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body) and ABDOMINAL DISTENSION (Abdomen was swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included DEXLANSOPRAZOLE (DEXILANT), SERTRALINE HYDROCHLORIDE (ZOLOFT), ACETYLSALICYLIC ACID (BABY ASPIRIN) and cholesterol medication for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body), ABDOMINAL DISTENSION (Abdomen was swollen), RASH (Right side of her stomach (underneath breast) had some rash), FIBROMYALGIA (Patient feels like having symptoms of fibromyalgia) and TENDERNESS (Right side of her stomach (underneath breast)was tender). At the time of the report, VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body), ABDOMINAL DISTENSION (Abdomen was swollen), RASH (Right side of her stomach (underneath breast) had some rash), FIBROMYALGIA (Patient feels like having symptoms of fibromyalgia) and TENDERNESS (Right side of her stomach (underneath breast)was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left arm extremely sore with throbbing sensation.  Could not raise left arm very far without hurting.  Extremely strong headaches.  Sick at stomach. Felt for 2 and 1/2 days following injection.
Very mild arm soreness at injection site for 1-2 days, but otherwise no notable side effects until 5 days later: dizziness. First night, it was very difficult to sleep - I did not get much. Dizziness was like being very drunk. Now every night laying down in bed looking up is dizzying, some nights worse than others but not as bad as first night of symptoms. This has been persistent for about a week. Some temporary dizziness when reorienting head quickly during the day, particularly looking up or down, but mainly worse at night in the dark, not debilitating. Sleeping with some low lights on helps reduce spinning feeling. Mild headache and tight neck/shoulders starting 9 days after injection but may be unrelated.
pt received vacciner felt pressure at site immediately then felt pressure/pop feeling in abdomen, pt states has anxiety and was anxious all day prior to receiving vaccine  after receiving vaccine states anxiety worsened and pt felt lightheaded, pt taken back to med obs for further evaluation, upon receiving in med obs pt in wheelchair while sitting in wheelchair pt felt warm throughout body, pt transferred to stretcher to laying down, pt tearful and stating very anxious about the vaccine and has severe anxiety in past.  vs as noted. tried to use distraction therapy with pt by talking, providing drinks and snacks. after talking pt feeling better, pt states was diagnosed with prehypertension last year and not currenlty on any meds. pt then shaky after anxious feeling going away, given  drape and jacket for warmth. as patient talking and calming down bp decreasing and pt states symtpoms subsided, vaccine site healthy. pt feeling better and at 5:12 pt okay with discharge from med obs and taken to exit to meet husband outside to drive her home. a; ambulated to exit vs: 4:06 bp163/110 hr115 rr 22 o2 100, 4:10 bp 167/91 hr 100 rr 22 o2 100 4:22 bp 194/102 hr 108 rr 20 o2 100, 4:25 bp163/101 hr 102 rr 20 o2 100 4:45 157/95 hr101 rr 20 o2 100  5:00 bp 142/93 hr110 rr 20 o2 100
Breakthrough case admission after 4 vaccines Moderna 5/20/21 Lot# 005C21A;  Moderna 6/17/21 Lot# 006C21A;  Moderna 1/7/22 Lot# 033F21A;  Pfizer 9/9/22 Lot# GJ2524
Started with nausea, he said he went to the bathroom, he came back and vomited at 3:30pm, we gave him a wet paper towel to wipe his mouth and nose.  Gave him another wet paper towel to wipe his forehead and gave him a water bottle.  He started to have chills, he was in a t-shirt and shorts.  His girlfriend gave him her jacket and we gave him a smock to put over his legs to warm him up.  35 minutes after the vaccine (3:55pm) he said he was fine and left with his girlfriend and another friend.
Pt with COPD arrives with worsening shortness of breath.  Admitted for acute hypoxic respiratory failure and COVID-19.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 19-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-265450 (Patient Link).
VARIVAX given 6/29/10, became red, raised (the size of a half of golf ball, painful and itching at site of injection.  Physician said it was cellulitis.  Treated with antibiotics & resolved without complications.
Unexplained acute pancreatitis on May 26, 2 weeks and a day after 2nd dose. I had severe abdominal pains and vomiting that started at 11:15 am. I was taking the the emergency room where it was diagnosed with CT scan and blood work. My Lipase levels were over 6,000. I was admitted into the hospital and treated with saline, no food and water, and pain killers for 3 days. No issues with other organs and I am not a heavy drinker. They found no reasons why I got this.
One week after vaccine developed what is being called "Covid arm". Redness, swelling and itching at vaccine site. Circular rash has grown on left arm and now have a rash on my neck and shoulders.
Blisters on feet; red splotches/bumps on feet, knees, over many parts of my body. I now suffer from dermatographia. I had parts 1 and 2 of the Pfizer shot earlier in the year with NO reaction so maybe it's the flu shot? I have never had a flu shot.
Severe leg muscle cramps all the way to feet. Numbness and tingling. Lasting well over an hour at this time
Pt reports getting cellulitis in right arm after receiving PNEUMOVAX. Pt was prescribed doxycycline from MD.
Narrative:  COVID infection following completion of COVID vaccine series 03/03/21 COVID vaccine dose #1 03/24/21 COVID vaccine dose #2 07/01/21 Pt reports to ED w/ c/o pain to ears, eyes; 2 wks of HA, sore throat, chest discomfort and left sided abdominal pain. Pt developed diarrhea today. Pt denies fevers but reports chills at times. No sick contacts or recent travel. Treated with dexamethasone 8mg IV and rx'd ibuprofen, COVID AND STREP NEGATIVE 07/22/21 Patient seen in ED with reports of fatigue, non-productive cough, sore throat, headache, right ear pain, swollen glands in right neck, body aches, chills started yesterday. States "i feel warm but not thermometer at home, my both eyes hurt when i touch them;" discharged from ED with rx for albuterol, ascorbic acid, aspirin, benzonatate, cholecalciferol, guaifenesin; COVID POSITIVE 07/23/21 patient reports chills, cough, headache, loss of taste/smell, muscle pain, runny nose, sore throat 07/24/21 patient reports feeling much better, more energy, o2 sats wnl 7/25/21 patient denies symptoms 08/01/21 Remains asymptomatic, clinically resolved infection
Vertigo - Sometimes when changing head position when lying down and when changing body position from sitting to standing or bending over.
Pt. states that after receiving the 2nd dose of Phizer 04/27/2021, started experiencing symptoms 08/24/2021 of a Ischemic Stroke (blood clot in the brain). 6 weeks Rehabilitation, at a local Medical Center.
Patient was given the moderna covid vaccine on 3/16/21 and arrived to our clinic for his second dose. He was mistakenly given the Pfizer vaccine instead of the moderna vaccine.  He was monitored for 15 minutes and did not experience any adverse side effects. Within this time frame the MA noticed she gave the wrong vaccine as the second dose. The Nurse Manager was notified and the patient was notified of the incident. Provider was notified as well.
A few hours after receiving the second shot for the Moderna COVID-19 vaccine I experienced headache and soreness at the injection site.  The following day I experienced: soreness at the injection site, headache, body ache & fatigue.
Patient received Moderna vaccine under the age of 18 years old. Patient had no adverse reaction.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis (lot #, expiration date, dose, route and site of administration were not reported). The temperature and time frame of excursions were unknown by reporter. There were also previous unspecified temperature excursions. The Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010657: US-009507513-1707USA000440: US-009507513-1707USA000441: US-009507513-1707USA000442: US-009507513-1707USA000443.
Papules / vesicles 5-8 on abdomen, 2 spots on right arm, 4 spots on both legs, some are scabbed.