chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seriousness Criteria other medically significant (OMIC). Initial report received on 5/17/2006 from a health care professional. A two month old male patient with a history of gastroesophageal reflux and who was taking Zantac had received his first intramuscular dose of ActHib, lot number UE785AA (manufacturer lot number Z0074-2), in the left anterior thigh, his first intramuscular dose of Daptacel, lot number C2375AA, in the left anterior thigh, his first intramuscular dose of Ipol, lot number Y1049, in the left anterior thigh, his second intramuscular dose of Hepatitis B vaccine, in the right anterior thigh, and his first intramuscular dose of Prevnar, in the anterior thigh on the afternoon of 3/13/2006. On 5/15/2006, the mother reported to the physicians office that sometime during the evening of 3/13/2006. after receiving the above vaccinations the patient developed a fever of 103.0 degrees F that lasted thru the night. The patient was very irritable and on two different occasions during the night he stopped breathing. The mother was able to arouse the child and he was ok. She contacted the physicians office that evening and spoke with the physician on call. It was not reported if any treatment was provided or if the patient was seen by a physician. No diagnostic laboratory testing was completed. The patient had previously had an EKG done at birth that was within normal limits. At the time of this report, the patient had recovered from the adverse events. The patient subsequently experienced fever and episodes of his hands and feet turning blue. This case was considered as serious and is reported in case 200601187.
pt.had adverse event from receipt of the above vaccine. Pt. experienced diaphoresis, dizzness, weakness and syncopal episode. Pt. given 1 dose of Epinephrine IM `PER ALLERGY IMMMUNOTHERAPY PROTOCOL. Escorted to MACD via wheelchair.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.  Past medical history included no previous pregnancies.  The subject and the father of the baby were smokers.  Prior to becoming pregnant the subject did not use contraception.  On 29 August 2011 at 15:00 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, right deltoid), and experienced vaccine exposure during the third trimester of her pregnancy.  The subject was approximately 37 weeks gestation at the time of vaccination.  The conception was reported to be normal.  Date of last menstrual period was 07 December 2010 and estimated delivery date was 13 September 2011.  Prenatal testing including ultrasounds on 25 April 2011 and 11 July 2011, and maternal serum alpha-fetoprotein on 28 March 2011 had revealed no evidence of a defect.  There were no adverse events at the time of reporting.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 25 April 2011 and 11 July 2011, and maternal serum alpha-fetoprotein on 28 March 2011 revealed no evidence of a defect.
Anaphylaxis; A spontaneous report was received from a consumer concerning a 34-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for COVID-19 infection prophylaxis.  On 09 Jan 2021, 15 minutes after receiving the mRNA-1273 vaccination, the patient was taken to the hospital for anaphylaxis. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, anaphylaxis, was unknown.; Reporter's Comments: This case concerns a patient who experienced a serious unexpected event of Anaphylaxis. The event occurred 1 day after first dose of mRNA-1273.  Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A nsg reported that a pt with a history of hypersensitivity to Motrin and orange dye rec'd his 5th dose of DTaP (manufacturer unknown) vaccine on 2/12/01. 6 hrs later the child developed an injection site reaction characterized by pain and swelling, with redness, warmth and pruritus from deltoid to tricep. The pt was treated with a 5 day course of Keflex therapy. This report was rec'd from a nsg via Merck & Co, Inc.
I went to the doctor as soon as i had chest pain.  It took them almost a year bewteen m,y doctor and cardiologist to diagnose this a pericarditis.  The pain level was a seven every time i breathed in.  My treat ment is to take 800mg ibuprofen 3 times a day and colchicine .6mg twice a day.
March 2, 2021 1.  At vaccination site, severe itchiness, dizzy, felt really hot, sweaty.  Nurse  took blood pressure 120 over 80.  Stayed for 1/2 hour (9:10-9:41 a.m.). 2.  Drove to work .  All symptoms persisted, entire body turned bright red (like sunburn), extreme shaking.  Checked in  with school MA (nurse) .  Blood pressure 140 over 80.  Temperature 100.  Extreme agitation and heightened senses. 3. sent me to  Urgent Care seen at 11:35 a.m..  Same symptoms persisted.  Blood pressure 143/94.  Temperature 98.8.  Was prescribed 2 Benedryl  now, 1 every 4-6 hours as long as have itching. 2 at night for next 7 days.  Prescribed Prednisone (10 mg) 4 one day, 4 next day - decrease dosage for 8 days. 4.  Took prednisone- heightened senses, agitation increased.  Migraine.  Outer body exhausted, inner pure adreneline that would not decrease.  March 3, 2021 1.  Most symptoms lessened.  Went to work .  Checked in with MA (nurse)  and told her that I wanted to stop the prednisone.  She recommended that I take the dose.  Took 4 tablets (10 mg) at 9:40 a.m.  Heightened senses (light, sound, touch, taste), agitation, shakiness.   brought me to  in .  Doctor told me to stop the prednisone as I have a history of anxiety.  Exhaustion, heightened senses, agitation remained the rest of the day.  March 4, 2021 1.  Lessened symptoms.  Four 20-minute recurrence  episodes between the hours of 9 a.m. and 5 p.m.
Head ached started about 2 hours after dose, later in the day slight nausea, and joint pain that lasted for 3 days.
Initial unsolicited report received from a pharmacist (consumer) on 08-Sep-2017. This case involves a 50-year-old female patient who was vaccinated with a first dose of ADACEL (Batch number: U5654AA, expiry date: 27-APR-2019) in left arm via intramuscular route on 06-Sep-2017. Illness at time of vaccination: None, Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): Not Provided. Any other vaccinations within 4 weeks of vaccinations noted above reported as none. On 06-Sep-2017, same day following the vaccination, the patient felt off she has tiredness and lightheadedness, patient said it went away and then came back last night with numbness to the left side of face including eye ear and top of head. Numbness on the top of her head, left eye and facial numbness, left sided tingling, lightheaded. Patient went to the emergency room as instructed by the nurse line of her insurance and they did testing and all were negative they told her it was a vaccine reaction and that she needed to be seen and evaluated by her primary provider for follow up she is awaiting a call back from them about an appointment. Patient was looking for info on course of action post AE and longevity of symptoms advised her everyone is individual and we can't provide info on this that she is following the right course of action with seeing her PCP who will evaluate her ER visit findings and make recommendations from there. EKG, CT scan, Blood work, all normal results. The patient received corrective treatment was not reported. On an unspecified date, patient was recovered from event tiredness and lightheadedness. The patient was not recovered from other events. List of documents held by sender: none.
Pt recd vax 27FEB91 & 27AUG91; 27FEB91 adm to hosp for 1wk w/pneumonia, pleurisy & aggressive behavior; in PM 27AUG91, similar violent rxn; spouse indicated pt "has never been violent before & only connected events of 27FEB91 p/2nd inject";
ACUTE STROKE OF THALAMUS, UNSPECIFIED TYPE AND ARTERY 4/26/2023 TINGLING SENSATION
Mom states that on 9-13-14 patient was laying down his eyes started blinking quickly and he brought his fist up to his face and was shaking them. He then briefly stared into space for about 3 sec.
Red sore raised area. Used an ice pack. Spot got worse on 9/28 went to the doctor. Took Benadryl and Zyrtec. Came in today spot is still there, red and sore but a lot better.
Seven days after vaccine given, there was a lump at the site of injection, two days after that (9d after) there is a red rash 3in x 3 in and the are is hard. Today I iced it and last night I took Motrin
Left arm swollen, red, sore, tender to touch, warm below injection site and extended to left elbow by 1/28/05. Admitted to hospital for 2 days. Treated with Keflex IV. On Keflex 500mg for four times a days by mouth for 7 days. Medical records states cellulitis. msv
Received first dose day later complained of h/a, sore throat, cough and congestion lasting about one to two weeks. Received second dose one month later in afternoon. Developed h/a and sore throat later that night. Still c/o bad h/a and sore throat with loss of voice four days later. Treating with Advil and Dimetapp and Triaminic. Has not consulted PMD yet. Encouraged to consult doctor.
This spontaneous case was reported by a patient and describes the occurrence of MYALGIA, FATIGUE, and HEADACHE 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.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA, FATIGUE, and HEADACHE. At the time of the report, MYALGIA, FATIGUE, and HEADACHE outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he might get tested for COVID19. No concomitant and treatment medications were provided.
Swelling of entire left arm and shoulder with slight redness and warmth. Mother applying cool compress to area and giving child BENADRYL po. Instructed to continue treatment. Instructed to seek medical treatment if swelling increases or breathing difficulty occurs.
Case number PHEH2013US020780, is an initial spontaneous report received from the health care professional on 04 Oct 2013. This report refers to a 65-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: not reported) on 01 Oct 2013. After the vaccination, she experienced a lot of pain and she couldn't lift her arm and arm was red, on unknown date. She also broke out in rash, was feverish and felt like her heart was racing. She felt better on 04 Oct 2013. The event outcome was condition improving as of 04 Oct 2013. The seriousness and causality of the events were not reported. No additional information was available.
Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the first dose of Pfizer vaccine, patient experienced lightheadedness. This occurred within a couple minutes after administration of vaccine. Vital signs include BP 116/63, P 84, O2 100%. Cetirizine 10mg PO administered at 15:35. Patient felt comfortable with no additional or worsening symptoms upon leaving clinic.
Severe aches & pains, muscle cramps, headache, fever, fluctuating blood pressure
Vial was initially stored in the fridge 14-Dec-2022 and administered on the 19-Jan-2023; No adverse event; 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the fridge 14-Dec-2022 and administered on the 19-Jan-2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the fridge 14-Dec-2022 and administered on the 19-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the fridge 14-Dec-2022 and administered on the 19-Jan-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the fridge 14-Dec-2022 and administered on the 19-Jan-2023).    No concomitant medication was reported.  It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine was received.  9 patients received doses of the Moderna COVID-19 vaccine bivalent after its beyond use date lot AS7168B.  On 14-Dec-2022, the vial was initially stored in the fridge.  Pharmacist asked for advise and stability information, would like to know the validity of the doses and if the patients should be revaccinated.  Vials was of size 2.5ml which did not undergo any temperature excursions.  This case contains information for the 8th of 9 patients described by the reporter.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704964 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704964:Master case - 1st adult patient (vaccine start date: 13-Jan-2023)
sharp body pain; felt kind of crumby for the first day; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sharp body pain), MALAISE (felt kind of crumby for the first day) and FATIGUE (feeling very tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN (sharp body pain), MALAISE (felt kind of crumby for the first day) and FATIGUE (feeling very tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (sharp body pain), MALAISE (felt kind of crumby for the first day) and FATIGUE (feeling very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-405849, MOD-2021-405861 (Patient Link).
Rash, erythematous, cough, pyrexia, skin lesion, sneezing, rash pruritic, rash papular Information has been received from a registered nurse concerning a 9-year-old male with a history of faint contact dermatitis who on 19-Feb-1997 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live.  Concomitant vaccination 18-Feb-1997 included a first dose in the deltoid of measles virus live (+) mumps virus vaccine live (+) rubella virus vaccine live.  There was no illness at the time of vaccination.   On 19-Sept-2005 the patient presented with a fever, cough, sneezing, and a red itchy rash of about 70 lesions.  He was treated with over the counter lotion and oral diphenhydramine hydrochloride (Benadryl).  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information was received from the registered nurse who reported that on 19-Sept-2005 the patient had lesions, a slight cough, and sneezing.  Physical exam revealed about 73 papular lesions on the face, neck, chest and back.  No diagnostic laboratory tests were performed. There were no adverse events following prior vaccination.  No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Inadvertently gave an expired vaccination (I opened new vial) I gave her the vaccine then noticed the vaccine was expired on 10/6/22,. Vaccine was given on 10-10-22. I notified Dr an my supervisor.  Moderna was contacted and will attempt to attach their response.  I tried to contact the patient and her mailbox was full.
Narrative: Fully vaccinated, COVID positive on admission incidentally for cognitive impairment and a fall in setting of diarrhea.
Approximately two weeks after fist vaccination he began feeling poorly, with fatigue, decreased appetite, drenching night sweats, and lost approximately 5 lbs
Patient presented with:  tingling and numbness in the arm that she received that vaccine.  She was assessed by nurse and EMS.
From initial info received on 5/25/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 13 year old female pt received a routine booster of TD ADS ADULT, lot U1019AA, IM, left deltoid and a dose of hepatitis B vaccine, lot 10035N83005, IM, right deltoid on 5/7/04. That same day, the pt experienced a local reaction of redness, warmth and a "knot" at the site of injection. It was not specified at which injection site the reaction occurred. The pt was treated with ice packs, Benadryl and Motrin and recovered from these events. From additional info received on 8/13/04 from a health care professional, it was reported that the pt had previously received 2 doses of TD ADS ADULT on unspecified dates. It was also reported that the pt developed the reaction of injection site redness, warmth and a "knot" on his left arm where the TD ADS ADULT was administered. Per the reporter, no other narrative is available at this time. No further info is anticipated. This case is considered closed.
Initial report received from a health care professional on 12 Jan 2010: This patient was received FLUVIRIN (batch no. 104043P1, exp date 30 Apr 2010) on 12 Jan 2010. The patient under the age of 4 received a 0.25ml dose of FLUVIRIN. No adverse event was reported. The outcome of the event off label use was not reported.
Developed Shingles 3 months after Pfizer Bivalent vaccination. Went to the doctor the next week. Was having Breast Surgery on right breast to remove a growth the following week. Was still able to have surgery because the Shingles was mainly on left side.
Blood clots after covid vaccine; Migraine; Blood disorder after covid vaccine; Esophageal disorder after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots after covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced THROMBOSIS (Blood clots after covid vaccine) (seriousness criterion medically significant), MIGRAINE (Migraine), BLOOD DISORDER (Blood disorder after covid vaccine) and OESOPHAGEAL DISORDER (Esophageal disorder after covid vaccine). The patient was treated with BOTULINUM TOXIN TYPE A (BOTOX) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots after covid vaccine), MIGRAINE (Migraine), BLOOD DISORDER (Blood disorder after covid vaccine) and OESOPHAGEAL DISORDER (Esophageal disorder after covid vaccine) had not resolved.            Company comment: This is a spontaneous case concerning an adult female patient on treatment with Adalimumab for an unknown indication, who experienced the serious (medically significant) unexpected event thrombosis, on an unknown date after the second dose of mRNA-1273.  Migraine, esophageal disorder and blood disorder were also reported as non-serious events. It was reported that patient was treated with botox. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were reported. Reporters causality for all events was not reported with respect to Humira drug. 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.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult female patient on treatment with Adalimumab for an unknown indication, who experienced the serious (medically significant) unexpected event thrombosis, on an unknown date after the second dose of mRNA-1273.  Migraine, esophageal disorder and blood disorder were also reported as non-serious events. It was reported that patient was treated with botox. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per list. The benefit-risk relationship of mRNA-1273 is not affected by this report.