chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines administered after being in stored in fridge past 30 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event) in an 81-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medications were not reported.  It was reported that vaccines administered after being in stored in fridge past 30 days.  Treatment information was not reported.
Patient with Moderna COVID vaccinations x3, last dose the day before admission.  Patient found to be COVID detected upon admission testing.  Provider d/c note below:  "58 year old woman with a hx of ESRD on HD and uncontrolled DM type 2 who presented to the hospital with GI complaints and was incidentally found to be covid-19 positive. Though she initially required high amounts of O2 including HFNC, she was rapidly weaned down and tolerating room air shortly after admission with saturations in the high 90s and RR in the teens. This maintained throughout the entirety of patient's hospitalization. There was additional concern for a superimposed bacterial pneumonia due to CXR findings particularly R>L and so patient was started on CAP coverage which was continued on discharge. Patient received dialysis while admitted as well.  She was cleared for discharge on 12/24 but unfortunately had difficulties arranging transport with family or through the hospital. Patient left the following day with private transport."
High fever (102 degrees) for 36 hours starting 16 hours following the vaccine . Chills during fever (experience of feeling extremely cold, during  entirety of fever). Muscle /joint pain during the 36 hour window. 1.5 inch swelling (golf ball sized) at site of vaccine on left shoulder. swelling peaked at 16 hours from time of injection, swelling  receded by 24 hours from time from injection.
Extreme itching all over body except for face and bottoms of feet that started gradually and progressed over two weeks. Took Claritin everyday and Benadryl every night x 1 week. Symptoms seem to have resolved.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 28-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
covid pneumonia; diarrhea, stomach issues; weakness; no appetite; Covid; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who experienced diarrhea, got sick with COVID, stomach issues, weakness, no appetite, and covid pneumonia.    The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Eliquis, Omeprazole, and Metoprolol.   On 07JAN2021, approximately 7days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   Caller stated that her mother in law who is 88 years old received the Moderna vaccine on 07Jan2021 and within 7 days, she got sick. Patient had had diarrhea, stomach issues, weakness, no appetite and ended up with covid pneumonia. Treatment for the events included Regeneron antibody therapy. Caller would like to know if the therapy negated the benefits of the vaccine.    Action taken with mRNA-1273 in response to the event was not provided/unknown.  The events, diarrhea, got sick with COVID, stomach issues, weakness, no appetite, and covid pneumonia were considered recovered/resolved.; Reporter's Comments: This case concerns an 88-year-old female who experienced a serious unexpected event of COVID-19 pneumonia along with unexpected COVID-19, decreased appetite, and asthenia.  The events occurred 8 days after first dose of mRNA-1273. Treatment included Regeneron antibody. Further information has been requested.  Based on 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 spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's medical history included pneumonia in 2012. The patient had no drug reactions or allergies. On 13-SEP-2018, the patient was vaccinated with PNEUMOVAX 23, lot # N022703, expiration date 27-FEB-2019, intramuscularly in arm for prophylaxis. Other suspect therapies included FLUZONE administered on the same day in the same arm. On 20-SEP2018 the patient came back to pharmacy complaining on redness, soreness radiating over her back, and black discoloration around injection site, she was experienced since unknown date in September 2018. The patient saw her unspecified physician and was told that the reaction was probably due to receiving both vaccines in the same arm. No treatment was given for an adverse events. The outcome of the events was unknown. Causality assessment between the events and suspect vaccines was not provided.
PAIN UP THROUGH NECK AND BACK, STOMACH PAIN, SWOLLEN TONGUE AND ROOF OF MOUTH
Moderna COVID-19 Vaccine EUA  Insomnia lasting until 4:00 AM the following morning.
Severe headache starting that day lasting 3 days. Severe upper back/lower neck pain as well as shoulder blade. I can barley even move my head without pain.
Itching from head to toe every afternoon , have been taking Benadryl tablets and using ointment as well  for the last  5 days.
Post covid shot after having COVID in Jan developed chest pain..tingling in hands...and breathing issues. Working with hospital post covid treatment team. Possible auto immune disease
shingles; This case was reported by a other health professional  and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 1st dose of Shingrix and experienced shingles. The reporter was asking when should be the 2nd dose given in such situations.
Intense screaming during  shot administered and lasted 16 hours until passed out, shallow breathing, high fever, and eczema developing within one hour. Wouldnt breastfeed and eat solids
Mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jun2021 13:30 (Lot number: EW0181) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Congenital hypothyroidism" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Gastritis" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing); "Herniated discs in the lumbar area" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; FIORICET; XYZAL; NORFLEX [ORPHENADRINE CITRATE]. The following information was reported: HEADACHE (non-serious) with onset 26Jun2021 14:30, outcome "recovered" (Jun2021), described as "Mild headache". Therapeutic measures were taken as a result of headache.  Additional information: The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Synthroid 175mg, Fioricet, xyzal, norflex within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date : 27Jun2021. The patient was treated with two Tylenol. The patient had COVID prior vaccination.  Follow-up attempts are completed. No further information is expected.
Redness and red spots on (R) thigh 7 days after immunization (also some induration).
c/o Body aches & headache starting 02/26 c/o nausea & vomiting on 03/03 & 03/04. States "fever" on 03/04 & "Breathing discomfort". Visit to Clinic urgent care & was told that o2 sats were slightly below 90 (88). Instructed to "sit up for better oxygenation & follow up with regular provider. No treatments were prescribed.
Redness, swelling, inflammation noted at right deltoid approximately 24 hours after injection of DTaP and IPV. Treated symptomatically with cool compresses/Benadryl.
This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. Pertinent medical history, drug reactions/allergies were reported as no. On 01-APR-2010, the patient was vaccinated (route not provided) with VARIVAX (Merck) (lot number 1328Y, expiry date 16-SEP-2011) dose 1. Other suspect therapies included hepatitis A virus vaccine (unspecified) (manufactured by GlaxoSmithKline) and M-M-R II. Concomitant therapies included ACCUNEB and PULMICORT. The patient presented on 12-APR-2010 in the emergency room with seizures (life threatening and medically significant), a 103.5F temperature (life threatening) and a rash that was documented as varicella (life threatening). The nurse practitioner stated that the patient continued to have a persistent rash on her face, hands and on the side of her body (life threatening). The nurse practitioner stated that the patient received an unspecified treatment for this rash, which goes away and later comes back. The nurse practitioner stated that the rash was now getting infected (life threatening) and she was not sure if this rash was shingles (life threatening). The patient was treated with TYLENOL, MOTRIN and OMNICEF. A EEG was performed on an unknown date but no results were reported. The outcome of the rash is now getting infected, not sure if this rash is shingles, patient continues to have a persistent rash on her face, hands and on the side of her body, rash that was documented as varicella, a 103.5F temperature and seizure was reported as not recovered/not resolved. The event seizures was assessed to be medically significant upon internal review. Additional information has been requested.
This spontaneous report as received from a health care worker refers to a 19 year old patient with no drug reaction, allergies and no concomitant medication reported. On unknown date the patient was vaccinated with GARDASIL. The patient had the first dose of GARDASIL at 16 years of age (in approximately 2011) and was at age 19 years of age to receive the second dose of GARDASIL (dose 2, 0.5 ml, intramuscular) today (on 14-MAY-2014). Additional information has been requested.
Rapid or fast heart beat 89-90 beats per minute. Lasted for approximately 8-9 hours
lightheaded/head is not right; head is not right, feels a little bad, and heads screwed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head is not right, feels a little bad, and heads screwed) and DIZZINESS (lightheaded/head is not right) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for an unknown indication.     The patient's past medical history included Liver transplant in 2021. Concurrent medical conditions included Hepatic cancer since 2021.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (head is not right, feels a little shitty, and heads screwed). On 29-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (lightheaded/head is not right). At the time of the report, FEELING ABNORMAL (head is not right, feels a little bad, and heads screwed) and DIZZINESS (lightheaded/head is not right) outcome was unknown.            Patient had cancer in the liver and had a transplant a couple of months ago. Patient was asked to wait 6-7 weeks before getting booster dose. Patient had booster dose and Moderna vaccines shots before. Patient reports that after the booster shot, he experienced lightheaded or a little dizzy, head was not right, feels a little bad, and heads screwed.  He experienced dizziness form 29-Jan-2022 when he reached down and grabbed something.  Patient was on other medication for transplant and won't go through them all.  No Treatment information was reported.
felt Jittery; This spontaneous case was reported by a patient and describes the occurrence of FEELING JITTERY (felt Jittery) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING JITTERY (felt Jittery). At the time of the report, FEELING JITTERY (felt Jittery) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.  Patient reported that he will go to the doctor next week.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received; No information provided in it.
Woke up at 3:15 a.m. shivering and feeling feverish. Within 15 minutes, I started vomiting. 20 minutes after that, I also had diarrhea. I felt very weak and achy. My arm hurt more than it did with the fist dose, tho by moving it around, it got better. After about 8 hours, the nausea and diarrhea pretty much subsided but I still felt very weak, I couldn't do anything but lay on the couch. The fever lasted until about 9:00 p.m. when it broke and went from 104.2 to 101.5. The next day I was still weak but only running a very low grade fever and able to move around and eat.
Chills, sore throat, nausea, vomiting, body aches, malaise, headache
Pfizer Dose 1 2/16/21 (EN9581); Pfizer Dose 2 3/9/21 (EN6204); COVID Positive 1/11/22. 1/12/22: Patient is a 78-year-old female with history of COPD on home O2, pulmonary nodules, tobacco abuse, hypothyroidism, HLD, and chronic anemia.  She presented to the emergency department yesterday with complaints of low back pain.  She had limited evaluation, and was discharged home after being evaluated by physical therapy.  The patient reports that after she returned home last night, she has been unable to get out of her reclining chair due to significant weakness.  Also reports an inability to urinate.  Denies shortness of breath at rest.  Reports chronic cough related to her COPD.  Does not feel this is any worse at this time.  Also reports chronic leg edema. No history of heart failure on file.   Patient thinks she had a low sodium level once before. She thinks she used to see the group for Nephrology. She does not take sodium tablets at home.  Does not think she drinks an excessive amount of water.  Tells me she drinks eight 8oz glasses daily, plus several cups of coffee.  In the ED, vitals have been stable and the patient has not required any supplemental oxygen.  CXR showed no acute processes.  Labs were significant for sodium 114, CK 785. UA was positive for protein, blood, wbc's, rbc's.  The patient was given 1L of normal saline in the ED.  Dr. was consulted from the ED.  He would like a BMP at 15:00 and he will see the patient this evening.  1/18/22: Patient is a 78-year-old female with history of COPD on home O2, pulmonary nodules, tobacco abuse, hypothyroidism, HLD, and chronic anemia. She was treated for COVID 19 pneumonia, hypoxia, UTI and severe hyponatremia. A chest x-ray appears unremarkable.  With clear lungs,  Pulmonary vasculature is normal. No pneumothorax or pleural effusion. She received IV antibiotic, neb treatments and remdesivir which completed on 1/17/22. Na level was 114 admission and Nephrology consulted. Today sodium level 136 after treatment with IV lasix and fluid restriction. Nephrology recommendation reviewed and patient to continue with Lasix 20 mg oral twice a day.  Patient to continue with fluid restriction as well.  She was seen and evaluated at bedside.  She also completed IV antibiotic for UTI. Repeat UA came back negative. She denies shortness of breath , chest pain, palpitation, nausea, vomiting, abdominal pain, dizziness any other discomfort. The patient reports improvement on her symptoms and is able to maintain her sats above 90% 4 L nasal cannula.  She was able to work with physical therapy who recommended skilled nursing placement. Patient was approved for SNF and transfer to Allure in Moline. Patient's family have been updated.
I woke up on 12/31/2021 in so much pain I could barely walk or move.  Every muscle and joint hurt, I walked like I was 90 years old.  My lymph nodes swelled so much I ended up having headaches and migraines.  I went to the chiropractor 3 times in less than a week for pain and headaches.  My arm burned and hurt for at least two weeks.
Patient received vaccine series at a separate facility. I do not have access to this information. He reported receiving Moderna dose #2 on Tuesday, June 8. Within hours, he began to have chest pain, shortness of breath, general body aches and fatigue. Chest pain was worse with deep breath and worse with supine position.  On Friday, June 11, he presented to The Clinic at  with these complaints. He was noted to be in evident severe discomfort, though not in respiratory distress. Vitals as follows: pulse 82 and regular, BP 139/68, respiratory rate 20, temperature 99.2 oral, SaO2 98% on room air. Exam was notable for absence of a pericardial friction rub. Lungs were clear to auscultation. he had no rashes and no remarkable tenderness of the body to palpation. Extremities were without edema. There was no sign of clinical heart failure or cardiovascular insufficiency.
Fever/fatigue/dizziness/site soreness afternoon and evening of June 17. Sore arm lasted about four days. Fever/fatigue/dizziness resolved within 24 hour. Red, feverish patch on skin around injection site beginning June 25.
Moderna covid vaccine administered 1720 Hx of anaphylaxis to flu shot ?about 8 years ago? (of note, was not intubated/admitted/etc) Patient requested extended monitoring due to hx. Placed in wheelchair at pharmacy station.  1730 patient states a scratch throat and itchy nose. Able to swallow water provided. 1800 patient continues to experience throat ?lump? and is clearing throat, nose itches             Requests diphenhydramine-given 25mg PO x 1 ingested without issue 1830 patient complains of itchy scalp and has a red flush to chest and upper arms 1832 patient wheeled to ER by  From ED note: Electrocardiogram was without acute change. The patient was observed in the emergency department, is feeling much improved. Still has a very slight sensation of a lump in her throat, but no angioedema of lips or tongue. No stridor. No shortness of breath. O2 sat is excellent at 100%. She is comfortable being discharged to home. No meds given in ED.
Information has been received from a nurse practitioner concerning a 26 year old patient who on 08-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck). It was reported due to human error. The patient had no symptoms. A product quality complaint was not involved. Additional information has been received from a nurse practitioner who stated that the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (MSD) on a different day. There were no adverse effects and the mistake was primarily because by product placement in the refrigerator. A wrong vial was grabbed and was reported as a human error. Additional information has been requested.
Body aches, headache, sore neck, throat feels swollen, 99.5 temp.