chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt fainted about 5 minutes after receiving vaccine. He was seated and fell to the ground facedown. We turned him over onto his back and he slowly regained consciousness. Paramedics arrived shortly afterwards.
Flu shot in (L) arm at 11:00 on 10/1/18 to employee health received MMR in (R) arm about 13:00. Broke out with rash over body on 10/3/18 rash progressed facial rash, itching difficulty breathing.
Fever 101.8 Muscle Aches Arthralgia  Chills Sweats  Fatigue Arm soreness
headache off and on mostly on; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache off and on mostly on) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache off and on mostly on). At the time of the report, HEADACHE (headache off and on mostly on) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report as received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L040414, expiration date 13-APR-2017, subcutaneously (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 21.18 degrees Fahrenheit for 10 minutes. A digital data logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, as the reported was unable to provide any further information. Sender's Comments: US-009507513-1703USA001642.
Extreme fatigue. Mild nausea. Any light activity, such as walking to the bath room, was exhausting.  Unable to perform any activities for five days. Visited family doctor.
Patient developed a red, swollen, hot, hard area where vaccine was administered.  Caregiver was concerned of cellulitis as it progressively got worse not better. They sought care at urgent care where it was determined that it was an allergic reaction and steroids were administered/prescribed.  Patient's caregiver has reported the swelling and reaction has gone down and patient is feeling better after taking steroids.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX, lot number 1013068 which is not valid for VARIVAX, expiration date 14-APR-2017. Concomitant therapy information was not provided. On an unknown date, there was an incorrect product storage as the patient received a dose of improperly stored (Oka/Merck) VARIVAX. No adverse events were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
No adverse reaction, Vaccine was give n after the 12 hour puncture vial  Patient will be contacted to revaccinate
Dental infection; chills; Bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Dental infection), CHILLS (chills) and MYALGIA (Bodyaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Tooth extraction (7 or 8 teeth extracted) on 08-Apr-2021. Concomitant products included ADALIMUMAB (HUMIRA), METHOTREXATE, FOLIC ACID, VITAMIN D [VITAMIN D NOS] and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Dental infection), CHILLS (chills) and MYALGIA (Bodyaches). At the time of the report, TOOTH INFECTION (Dental infection), CHILLS (chills) and MYALGIA (Bodyaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Achy from head to toe; Hoarseness; Sore throat; Difficulty breathing; Wheezy; Fatigue; Pain in arm; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), PAIN (Achy from head to toe), DYSPHONIA (Hoarseness) and PAIN IN EXTREMITY (Pain in arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. lot 013220A and Lot 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 19-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), WHEEZING (Wheezy) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Achy from head to toe). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), PAIN (Achy from head to toe), DYSPHONIA (Hoarseness), PAIN IN EXTREMITY (Pain in arm), WHEEZING (Wheezy) and FATIGUE (Fatigue) had not resolved.            No concomitant medications were provided.  No treatment details were provided.
01/06/22 presents to ED for "dog bite to the face". PMHx of "appendicitis and depression"
Case number PHEH2013US010221, is an initial spontaneous report received from a nurse on 06 May 2013. This report refers to a male patient of unspecified age. His medical history and concomitant medication was not reported. He was vaccinated with expired MENVEO (batch number: M11062 and expired date: Jan 2013) intramuscularly on 03 May 2013. No adverse event was reported following this administration error. No additional information was available.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 26-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot# N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Chills & fever the 1st 2 days following injection; relieved by TYLENOL. Then 3-5 days later developed rash on arms & hands - small red spots that itched - gave BENADRYL.
experienced a big red, tender rash at the injection site; big red, tender rash at the injection site.; big red, tender rash at the injection site.; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE RASH (experienced a big red, tender rash at the injection site), INJECTION SITE PAIN (big red, tender rash at the injection site.) and INJECTION SITE ERYTHEMA (big red, tender rash at the injection site.) 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.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (experienced a big red, tender rash at the injection site), INJECTION SITE PAIN (big red, tender rash at the injection site.) and INJECTION SITE ERYTHEMA (big red, tender rash at the injection site.). At the time of the report, INJECTION SITE RASH (experienced a big red, tender rash at the injection site), INJECTION SITE PAIN (big red, tender rash at the injection site.) and INJECTION SITE ERYTHEMA (big red, tender rash at the injection site.) outcome was unknown. Not Provided      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.   No relevant concomitant medications was reported. Treatment details was not reported by the reporter.
Child received a 4th DTaP and IPV as well as a 5th Hep B when she was given a Pediarix vaccine 4/22/09 at less than 12 mos old, 1 Pediarix not on client's personal card. The client also received a Prevnar and Hib vaccination 4/22/09 at less than 12 mos old due to misreading of handwriting. Parent was notified of invalid doses.  Parent will have client return at 15 mos for Prevnar. Hib will be repeated when shortage ends.
Mom called health dept "just wanted to report child's reaction to shots" States called private medical doctor but they did not report- I called private medical doctor they requested I fill form. Mother of patient states child developed fever then diarrhea, vomiting, fussiness, malaise and poor appetite after received immunization- Fever 103.7 degrees- She states private medical doctor told her may be viral may be do to shots. Doctor gave Tylenol.
Flu like symptoms.  General weakness.  Headache.  Low exercise tolerance.  Not able to work.  Symptoms lessening  after 4th day.
Pt was given 2nd COVID vaccine at 6wks instead of 8wks. 1st vaccine was bivalent and 2nd dose was Comirnaty.
Patient was vaccinated with a vial that had been in the refrigerator past the 30 days; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a vial that had been in the refrigerator past the 30 days) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a vial that had been in the refrigerator past the 30 days). On 25-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a vial that had been in the refrigerator past the 30 days) 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.   No concomitant medications were provided. No treatment drugs were reported.
All my muscles are sore.  My back hurts.  I feel "stiff" all over.
arm swelled up a little bit; little tired; a small rash in the shape of a circle about 6 hours later that was itchy/ she got a rash at the site; a small rash in the shape of a circle about 6 hours later that was itchy/ she got a rash at the site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "she had no issues"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "she had no issues"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she had no issues"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she had no issues"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "rash". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 03Oct2023, outcome "recovered" and all described as "a small rash in the shape of a circle about 6 hours later that was itchy/ she got a rash at the site"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "arm swelled up a little bit"; FATIGUE (non-serious), outcome "recovered", described as "little tired".  Additional Information:  Reporter stated that all of her Covid 19 vaccines have been Pfizer products. She was uncertain how many doses she's had. On her first 3-4 doses she had no issues. She got Pfizer Comirnaty 2023/2024 for adults on Tuesday morning (03Oct2023) in her right arm and she  developed a small rash in the shape of a circle about 6 hours later that was itchy and was going away. Her arm swelled up a little bit but was going down. Rash color was fading and was less itchy. Its topical and she didn't have any issues with breathing. The reaction was mild with no fever or other symptoms, other than maybe a little tired, but she didn't noticed much at all this time. She also had a rash with the previous dose she receive which was the bivalent. Reporter asked if anyone else reported this and asked if one face can swell up. She asked that if she got a rash at the site, does that mean she will get the same reaction with future doses or get worse. Further mentioned that if she had it Tuesday and its already Friday, she is feeling fine, she asked if it is to assume that she won't get any other side effects later. Caller also asked how long does it take for the vaccine to be effective - 10 days or how long.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizziness within minutes, then headache and fatigue - day 1 headache and fatigue continued on day 2 headache, nausea, fatigue, diarrhea, low grade fever on day 3
Vaccine given to left deltoid on 10/5, 10/6 - left upper arm was found to be red, swollen, hard, hot to touch and painful. S/S lasted through until today - still have swelling, firmness & soreness about the size of a quarter.
Within 15 minutes of the shot I was very lightheaded, nauseous and felt faint. I sat for an additional 15 minutes at pharmacy. I left because the Pharmacist told me to leave. I continued to be lightheaded, felt faint and nauseous the rest of the day.  Within about 2 days of the first shot, my neuropathy in my neck and arm started to get worse. It has been three weeks and the neuropathy is still bad. I have not changed my normal routine. I am also having some swelling in my right hand as well that has not subsided. NOTE* the pharmacist noted that the injection was done in my left arm, which is incorrect. It was done in my right arm.
immediately following Injection, my arm started to itch. Started swelling, became red, and hot to touch. About size of Baseball. Duration 24 hrs.
Very sore arm day 1, dizziness and fatigue day 2, extreme dizziness, fatigue, sore throat day 3.
freeze arm; fell tired and icky; Headache; Arm sore; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (freeze arm), FATIGUE (fell tired and icky), HEADACHE (Headache), MYALGIA (Arm sore) and CHILLS (Chills) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure high, ESCITALOPRAM (DEPRALIN [ESCITALOPRAM]) for Stomach pain, VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (freeze arm), FATIGUE (fell tired and icky), HEADACHE (Headache), MYALGIA (Arm sore) and CHILLS (Chills). At the time of the report, LIMB DISCOMFORT (freeze arm), FATIGUE (fell tired and icky), HEADACHE (Headache), MYALGIA (Arm sore) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received on 21-Jul-2021 and included non-significant information
This spontaneous report as received from a physician refers to 2 patients of unknown age. The 2 patients were vaccinated with ZOSTAVAX on JUL-2011 ("one year ago") (indication reported as "shingles"). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on JUL-2012 the 2 patients were diagnosed with shingles "one year after ZOSTAVAX was administered". They were both severe cases of the shingles and had to be admitted and treated at the hospital. At the time of the report, the patients' outcome was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information is not expected.
Information has been received from a physician for the pregnancy Registry for GARDASIL concerning a 26 year old female patient with no pertinent medical history and no known allergies, who on 28-JUL-2008 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL, the second dose on 22-SEP-2008 and the third dose on 16-DEC-2008 and conceived 1 week later after the third dose.  The patient was seen on 18-MAR-2009 at the office and an ultrasound confirmed that the patient's gestation was 15 weeks and 2 days.  No adverse effect reported.  Follow up information has been received from a physician concerning a female patient who had not any previous pregnancies, spontaneous abortions, elective terminations or fetal deaths.  The EDD is 07-SEP-2009.  It was also reported that on 31-MAR-2009 the patient was transferred to another physician.  Follow up information was received from a certified nurse midwife.  It was reported that on 02-SEP-2009 at 39 weeks from LMP, the patient gave birth to a male baby.  The baby had a congenital anomaly, weighing 6 pounds and 1 ounce, with an Apgar score of 7/9.  It was reported that the patient experienced mild blood pressure increase at the end of the pregnancy.  There were no complications during labor/delivery.  All routine tests were within normal limits.  Follow up information was received from a physician.  It was reported that the patient was transferred to another practice since the physician no longer did obstetrics.  The baby's experience is captured in WAES 0903USA03210B1.  Short sublingual frenulum and dacryocystitis were considered to be congenital anomalies.  No further information is available.
woke up in middle of the night (around 1 AM) due to intense pain in injection site. Took advil and went back to bed. Woke up in the morning with extreme headache and neck pain as well as pain in injection site. Took tylenol which did not help the pain or headache. Headache worsened until about noon, at which point I could not move due to neck/arm pain and headache. Symptoms dissipated quickly away pretty quickly around 1 PM
I started with a scratchy throat a dry cough, I ended up the next day testing positive I had severe body aches, lots of back pain, I got super fatigued, I ran a fever of 101.5, congested, I literally has every covid 19 symptom except for vomiting and with in couple hours of testing positive I received the monoclonal antibody infusion, I had chills and within 24 hours I felt much better. I was still fatigues and a fever all symptoms just less intense. I'm 20 days post I still have a lingering cough and fatigue, and unusual depression. I lost my taste, I could still smell a little bit. Since having Covid I lost my menstrual cycle. I feel like 80% recovered.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 56 year old male. The patient's weight was 198 pounds, and height was 67 inches. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient had an antibody test which was negative (confirmed immunological vaccine failure). Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197564 This case, from the same reporter is linked to 20211028400.; Sender's Comments: V0: 20211028354-covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS