chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (forceps delivery Live, full -term birth) on 12-Apr-2015 and Pregnancy (no complication Live, full -term birth) on 11-Oct-2018. Concurrent medical conditions included Gestational diabetes. Concomitant products included VITAMIN B6, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CALCIUM LEVOMEFOLATE (METHYL FOLATE), CALCIUM and DOCOSAHEXAENOIC ACID (DHA) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Jul-2020 and the estimated date of delivery was 13-Apr-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2020, Pregnancy test: positive (Positive) Positive. On 20-Jan-2021, Glucose tolerance test: not provided (Positive) Gestational diabetes confirmed.. On 20-Jan-2021, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient reported that their tremors have gotten "much worse", in addition to feeling pain, sleepiness, agitation and general loss of function in the 2 days after the vaccine
irregular heart beat; administered possibly a double dose on the 2nd vaccine; administered possibly a double dose on the 2nd vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown" and all described as "administered possibly a double dose on the 2nd vaccine"; HEART RATE IRREGULAR (medically significant), outcome "unknown", described as "irregular heart beat". Therapeutic measures were taken as a result of heart rate irregular.  Additional information: Reported her brother was administered possibly a double dose on the 2nd vaccine and now is being treated for an irregular heartbeat. He is 64 years old and in good health. He had to have a procedure by a cardiologist for a heart ablation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        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.
Pfizer covid vaccine was stored outside of manufacturer's recommendation. Specifically, the vaccine was frozen longer than recommended. Patient reboosted on 12/07/2021 per recommendations from Pfizer.
Patient came back into the pharmacy to show me her reactions to the vaccine that she had received on Saturday afternoon. She has a half-dollar-sized red rash on the upper front portion of her right thigh. It appears to not be raised or itchy, but did appear after her vaccination. She also reports that she has a past medical history of recurrent but very infrequent oral cold sores.  Not soon after administration of the shingles vaccine, she developed a cold sore on the left corner of her mouth. These adverse events are not of concern to the patient, but she wanted to bring them both to my attention as a pharmacist.
Inconsolable crying within 1 hours of vaccine. Lasted more than 3 hours.
Received flu vaccine on 10/11 at 11:45am in employee health. received in right upper arm. developed numbness in right arm and fingers. then developed numbness in face with right side being greater than left several minutes after injection. right eye began to twitch for 30 minutes. pressure around right eye. numbness started to subside in about one hour but fingers and right side of face, especially under right eye, continues to feel numb and tingly. face and fingers remain to feel slightly numb and tingling several hours later. pressure continues around right eye with numbness under right eye several hours post injection.
Mother stated bilateral jerking motions began the evening of vaccines x 6. Early AM on 11/24 - jerking motions of one extremity noted x 5 - 10 times. Discontinued after 6:30 AM 11/24/10.
pt states day p/vax felt flu like sx & just feel really bad; had taken APAP & DPH during the past days;lt deltoid where Td given arm bruised & redden area 10-15cm 23OCT97 still feels draggy but says arm is much better;arm red & bruise;
Steroids between doses for their knee problems.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Steroids between doses for their knee problems.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Steroids between doses for their knee problems.). The patient was treated with METHYLPREDNISOLONE (oral) for Knee pain, at an unspecified dose and frequency and CORTISONE for Knee pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Steroids between doses for their knee problems.) outcome was unknown.            Patient reported that after getting the 1st dose of the vaccine consumer was taking oral methyl prednisone and  is concerned she might not be protected from initial vaccination series because she was prescribed cortisone shots and oral steroids between her 2 dosing series.  No concomitant drugs were reported.
Patient started developing redness, itching and pain on left arm where vaccine was injected. Patient went to emergency room on 6/5/23 and was given benadryl and hydrocortisone cream
Information has been received from a registered nurse concerning a 15 month old female patient with no pertinent medical history and no drug reactions or allergies, who on 07-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot # 668617/1144Z). There was no concomitant medication. The nurse reported that on 20-JAN-2011 the patient developed chicken pox. The patient sought medical attention called office. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the nurse indicating that the patient with none known drug reactions or allergies, on 07-JAN-2011 was vaccinated with a first dose of VARIVAX (Merck) (Lot # 668617/1144Z) in the right leg and a first dose of MMR II (Lot # 666247/0959Z) in the left leg. The patient went to office on 21-JAN-2011 with rash, rash spreading more than on 20-JAN-2011, diagnosed as varicella rash 2 degree to vaccine on 07-JAN-2011. At the time of the report, the patient had recovered. No further information is available.
With one day baby developed a drooping eye & twitching of leg. The eye drooping lasted a week & the leg twitching was intermittent for 6 weeks
10 days after MMR/varicella vaccines. Developed sudden fever to 102. Then papular rash began on trunk and spreading to limbs. Associate SX's include intermittent fussiness, decreased appetite, increased sleepiness.
Muscle soreness went away on 3/14 about 24 hours later. Never had this symptom in any other virus shot.
1443 Feeling anxious and "really hot". BP140/92,HR 110 Sp02 98% 1448 Same feeling but worse,asking to go outside. BP 145/88 HR 120 SpO2 98% 1500 Symptoms continue , BP158/97,HR81 SpO2 99.6% 1515 Symptoms continue , BP 152/89, HR 130 , 97% 1530 Symptoms continue, BP 143/98 HR 117, 97% 1535 Improved symptoms BP 148/98  HR 104, 100% 1540 Symptoms resolved  BP 130/91  HR 102 , 100%
Hospital Course and Significant Findings: 81 yo M with history of DM2, chronic anemia, HLD, prior colon cancer, COPD, ESRD on HD, tobacco user who presented with progressive shortness of breath x1 week found to have COVID-19.  I kept the patient for 48 hours to ensure that she was stable from a respiratory standpoint.  She did not require more than 2 L supplemental oxygen, and she was discharged on 1 L.  Also, she had hemodialysis on 12/20 and 12/22.  She was officially discharged on 12/21, but we were unable to secure hemodialysis chair for 12/22 so she stayed overnight for hemodialysis before transferring to Facility.
Information has been received from a registered nurse concerning 9 year old female patient with no previous medical history and allergies reported, who on 21-AUG-2000 was vaccinated with one dose of VARIVAX (Merck) (Lot number 657175/0498U, that was reported is valid for HIB conj vaccine. Concomitant therapy included Amoxicillin/Augmentin and Acyclovir-herpes simplex. On 23-FEB-2009, the patient was seen at the office, the patient was diagnosed with shingles at the back of the left back. On an unknown date, a chest X-ray was performed (results not provided). The patient's shingles at the back persisted. Additional information has been requested.
Lightheadedness, dizziness, and nausea. Redness and swelling at the injection site.
Patient developed a redness on her chest and neck with macular rash, surrounding erythema and warmth.  9-26-21 went to arms and legs.
Patient received their J&J vaccination on 4/7/2021. The patient's wife tested positive on 4/12/2021. The patient tested positive on 4/23/2021. The patient presented to the ER with a severe progressive cough (starting one week prior), worsening shortness of breath, a high fever, chills, myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana. The patient was admitted on the 23rd and continued to decline until their eventual passing on 4/28/2021.
pt recvd vax 21AUG92 & c/o soreness @ inject site; 21NOV92 lab eval showed anti-HBs neg; No further details provided;
after 24 hrs from receiving the second Covid vaccine, I started to feel the typical body aches and low grade fever. However, that evening my lips swelled and my hands and feel swelled along with being itchy on the hands and feet. I took a zyrtec and was better by morning. I did have intense shaking throughout the night and was freezing. I did take 2 doses of ibuprofen during the day on the 21st.
administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 24-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine). On 24-Dec-2021, ACCIDENTAL UNDERDOSE (administered a 0.25 mL booster dose to a patient instead of the 0.5 mL full dose for the patient's first dose of the Moderna COVID-19 vaccine) had resolved.        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.   Patient was not experiencing any symptoms.  Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
FALLS; LEGS TO GIVE OUT AT TIMES; NUMBNESS TO FINGER TIPS AND FEET; ENLARGE LYMPH NODES ON AND OFF; RASHES IN DIFFERENT AREAS ON BODY DAILY; BURNING SKIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was essentially a healthy person until the adverse events started. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced burning skin, rashes in different areas on body daily, and enlarge lymph nodes on and off. Laboratory data included: Hepatic enzyme noticeably increased on several occasions. On an unspecified date, the patient experienced falls, legs to give out at times, and numbness to finger tips and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning skin, rashes in different areas on body daily, enlarge lymph nodes on and off, numbness to finger tips and feet, falls, and legs to give out at times. This report was non-serious.
Waking nights with hip and leg pain about 10 days after shot. Burning ache in upper legs and hips persisting through the day. Spread to hands and wrists by 4 to 5 weeks from shot. Persistent pain and weakness in hands, wrists and legs 24/7. Bent in pain 24/7 although the symptoms flared significantly throughout the nights during attempted sleep.  Hospital visit determined systemic inflammation but could not specify source. Treated with Prednisone to reduce inflammation.
Headache; fatigue; runny nose; sneezing.  Started 24 hours post-vaccination.  Lasted for 3 days.  Resolved without intervention.
2 outbreaks of shingles, memory loss, nerve issues, hair loss. Can't work.
Fever and headache for 24 hours, then swelling and pain axilla bilateral 07/19/2006-07/22/2006, no reaction at injection sites in deltoid but much pain and swelling in the arm pit area.
A non-serious spontaneous report of loss of taste and smell has been received from a nurse practitioner concerning an adult female patient subsequent to receiving FLUMIST. Medical history and concomitant medications were not reported. On an unknown date five years ago, the patient received FLUMIST. After receiving FLUMIST, the subject progressively lost her sense of taste and smell. The outcome of the event is not recovered/resolved.
Mother reports child had an orange size reddened area on R thigh 24 to 48 hours after receiving vaccines. Mother reports she gave child TYLENOL and the reddened area decreased in size. Child did not see Dr.
Swelling began bilaterally in ankles. Swelling continued and spread to feet, toes, knees, wrists, hands, and fingers over the following weeks. Pain increased over this timeline as well.  Still unknown what is causing the issue.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 85.26.  Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM, temperature was 29 and at 10 AM was 32 respectively, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 02 and 04 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021.  On 22-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was given the high dose flu shot instead of the regular flu shot he should have received based on his age. Patient was informed of the error and will report any adverse events if they occur.
headache all day; pain in injection site; lethargy (too brain fatigued to work)
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 04-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J009827, 0.5 ml, intramuscular. No concomitant medication was reported. Pharmacist reported that the patient received expired dose of PNEUMOVAX 23 (lot #J009827, exp. Date 10-AUG-2014) on 04-SEP-2014. No adverse effect was reported. No further information was provided. No PQC involved. Additional information has been requested.
Rash the night of the vaccine - itchy, on arms, few spots on abdomen and legs - Still has rash 2 weeks later.
Chest, neck and facial  swelling, blistering, edema, and skin peeling. vision distortion, dysphagia, fatigue, and  voice change. Symptoms  lasted for one week.
patient that received 2 vaccines about a month a part from each other with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves adult male patient of an unknown age who received 2 Typhoid Vi Polysaccharide Vaccine [Typhim Vi] about a month a part from each other with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Nov-2023, the patient received 0.5 ml once daily (QD) of suspect Typhoid Vi Polysaccharide Vaccine Solution for injection (with an unknown route, administration site , formulation, strength, expiry date and lot number) for immunization.  On 13-Nov-2023, the patient received 2 Typhoid Vi Polysaccharide Vaccine [Typhim Vi] about a month a part from each other with no reported adverse event (extra dose administered) (latency same day).  It was reported, Caller stated that she has a patient that received 2 vaccines about a month a part from each other. Caller stated that the patient is fine and would like to know if there is anything else that she needs to do. The caller did not have any patient details, only that it was a male, 18-40 yrs old. What is docu wented to the only info available at this time. The caller did not have the lot# and exp date for the first product that was administered.  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 the 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.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a female with no pertinent medical history who in October 2008, was vaccinated with a first 0.5 ml dose of GARDASIL IM. On 17-SEP-2009 the patient, was vaccinated with a second 0.5 ml dose of GARDASIL IM. There was no concomitant medication. Subsequently, the patient found out she was pregnant. She was 20 weeks pregnancy on 18-FEB-2010. LMP was 30-SEP-2009, EDD was 27-JUN-2010. Ultrasound was normal on unspecified date. Pregnancy was reported to be normal to date. She sought medical attention in the office. Follow-up information has been received from a physician concerning a 20 year old female non-smoker, allergic to ibuprofen and latex, with no prior pregnancies and a history of cystitis and candidiasis (recurrent), and a family history of cerebrovascular accident (mother), who on 11-JUL-2010, at 40 weeks gestation, delivered a healthy 6 lb, 13 oz male baby via a normal spontaneous vaginal delivery. It was noted that patient delivered with postpartum anemia. The patient was seen on 24-AUG-2010 for a 6-week postpartum visit and had no complaints. She was prescribed ferrous sulfate and was continued on DEPO-PROVERA for contraception. It was reported the patient experienced weight loss with the DEPO-PROVERA. The patient was also advised to use condoms. All available medical records will be provided upon request. No further information is expected.