chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 15-JUN-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:
Patient reported feeling nausea, itching, and throat swelling, EMS checked vitals and took patient
This was an administration error, drawn into syringe and not given. patient had no visible symptoms.
Flu shot site redness; swollen; painful; hot to touch. use a cool compress on it.  You can give him Ibuprofen/MOTRIN for swelling.  TYLENOL would help with the pain.  Please let us know if the redness increases in size and/or patient develops a fever.  Resolved spontaneously
for approx 2 days p/vax pt exp sore throat, weakness, myalgias, nasal congestion;
Information has been received from a nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23.  Concomitant medication was not reported.  Subsequently, the patient experienced swelling at injection site.  The outcome of the event was not reported.  No further information is available.
NIGHT OF DIARRHEA AFTER VACCINE (4 TIMES). SHIVERING COLD IN THE MIDDLE OF THE NIGHT. WOKE UP THE NEXT MORNING WITH NO SYMPTOMS.
I developed a large red lump at injection site.  Proceeded to spread and got painful and hot.   Lasted 9 days then i went to my GP she said I had cellulitis.  Treated with Keflex. Area started to resolve within 24 hours. Today, 15 days after vaccine, area totally reolved.  I had no systemic reaction, only on the skin.
Severe hives/rash 4 days after MMR and polio given. I don't even know for sure which kind of MMR was given-the MMR II or PROQUAD with varicella. Both MMR and Polio shots are contraindicated in shots system because of certified immunity through titers testing. Father ignored shot record form and health care provider did too, but father refuses to disclose name of health care provider. The shots were not given at our daughter's doctor. I am following directions from Dr. BENADRYL is helping but 3 hours later patient is still recovering and not 100% better. Patient never breaks out like this.
Dose may have been reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter was an office manager. The reporter reported that they had an extra vial of Hiberix diluent so they believed that a dose might had been reconstituted with sterile water and possibly gave to the patient. The reporter stated that there was no specific patient at the time of the reporting and there was only speculation since there was an extra vial of supplied diluent. The reporter did consent to follow up via email. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution.
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M011116, expiry date 17-JUN-2017 and lot # K008333, expiry date 16-JUL-2017 (dose, route and site of administration were not reported). There were no known side effects reported. The vaccines experienced temperature excursion of maximum temperature of 22.7 degrees Celsius for 3 hours 48 minutes and minimum temperature of 0.2 degrees Celsius for 31 hours 1 minute. This is one of several reports received from the same source. Additional information has been requested.
pt. recd. vax & developed 2 small palpable nodules on neck @ hairline;resolved spontaneously;developed "dime sized" nodule on rt. neck. w/ 2nd nodule later. exp. intermittent rt. side shoulder,neck,arm,& hand numbness & weakness
intense pain in left arm; arm was useless; slight discomfort pain; Couldn't sleep; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Apr2021 08:30 (Lot number: ER8737) at the age of 60 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Arrhythmia" (ongoing); "Diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medications included: ELIQUIS taken for arrhythmia; INSULIN taken for diabetes mellitus. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 16Apr2021, outcome "recovered" (17Apr2021), described as "slight discomfort pain"; PAIN IN EXTREMITY (non-serious) with onset 18Apr2021, outcome "recovered" (22Apr2021), described as "intense pain in left arm"; MOBILITY DECREASED (non-serious) with onset 18Apr2021, outcome "recovered" (22Apr2021), described as "arm was useless"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "Couldn't sleep".  Additional information: Caller stated he was calling regarding the Covid Pfizer vaccine. Had really bad Covid arm in the left arm. Had very intense pain. It didn't start until 10 days after the vaccination. It was good for 10 days. Had 2 days of slight discomfort. Had a week of intense pain and the left arm is useless. Couldn't sleep for two and a half days. Took the vaccine 6 Apr 2021. On 16 Apr 2021 and 17 Apr 2021 had slight discomfort pain. From 18 Apr 2021 to 22 Apr 2021, had very intense pain. Couldn't sleep 2 and a half days because of the pain, until currently, today 23 Apr 2021 am back to slight discomfort. Had an ice pack on it right now. It was much better now. Treatment received was just ice packs. Yesterday, he went to take blood work. Was just routine checkup and it was not due to the left arm.   No follow-up attempts are possible. No further information is expected.
Size of a egg; Warm to the touch; Appeared red; Sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Size of a egg), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Appeared red) and VACCINATION SITE PAIN (Sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE MASS (Size of a egg), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Appeared red) and VACCINATION SITE PAIN (Sore). At the time of the report, VACCINATION SITE MASS (Size of a egg), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Appeared red) and VACCINATION SITE PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up information received on 12-Apr-2021 included no new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
No adverse event; Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023).    No concomitant medications were reported.  No treatment information was provided.  This case was reported for patient  5 of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:Patient 1
sore left injection site arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Patient called to report that Moderna #2 vaccine received on a Tuesday. Woke up on Wednesday morning with "really bad headache", "very confused" and "very weak". Denied any fever or chills. Now 2 weeks later she still has lingering leg weakness, "very weak" and fatigue and also hair loss.  She says she had no after effects with Moderna #1. She is now "getting back to normal" .
Clinical Varicella(chicken pox) infection-mild after receiving Varivax in 07/1998.
Information has been received from a registered nurse concerning a 37 year old female who on 6/8/04 was vaccinated SC with a dose of MMR (lot # 645516/0179N). On 6/8/04, the patient experienced a sore arm, soreness at injection site and daily headache. The patient was treated with acetaminophen and ibuprofen. The patient was seen by an occupational health doctor who gave her exercises to do for the sore arm. No additional information is expected.
Asthma exacerbation and tremors both started 2 days after receiving the COVID shot.  Asthma exacerbation treated with prednisone. tremors
Patient reportedly had severe chills, nausea, and passed out and could not be awaken.
flaccid paralysis of lt leg following OPV vax of child;preceded by severe h/a, probable VAP case;
really hot/hot to the touch; arm was really sore again; raised red; hurts; massive headache; arm was sore; A spontaneous report was received from a consumer concerning a 53 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) who experienced arm was sore/pain in arm, arm was really sore again/pain in arm, raised red/vaccination site erythema, really hot/ hot to the touch/vaccination site warmth, hurts/vaccination site pain, massive headache/headache.  The patient's medical history and concomitant medication were not reported.  On 15Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) in left arm for prophylaxis of COVID-19 infection.  On 19Jan2021, the patient experienced arm was sore. On 26Jan2021, the patient arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache. No Laboratory details provided.  Advil was given as treatment for the events.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event arm was sore is recovered on 21Jan2021. At the time of this report, the outcome of the event arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache is unknown.  The consumer assessed the event arm was sore, arm was really sore again, raised red, really hot/ hot to the touch, hurts, massive headache were not reported.
Received booster shot on Saturday November 13th. On Sunday, I had a sore arm from the injection site, muscle aches, fatigue, increased congestion, cough, and skin hurt to touch. On Monday, my skin didn't hurt anymore, fatigue was better, and muscle aches were better (not completely gone though.) I still had a sore injection site, with added pain in my left arm pit. Congestion and cough remained as well. I woke up to go to work. I felt more fatigued as the day went on. I developed severe shortness of breath by lunch time and noted that my heart rate was elevated. By 2:15pm in the afternoon, my heart rate was consistently 130's-150's at rest. I was extremely short of breath just with conversation. I had my blood pressure checked and that was also elevated. I called my OBGYN and I was told to be seen in the hospital. Of note, I'm 28 weeks pregnant, due Feb. 7th 2022. I ended up being seen at the hospital for observation, and during that time period my symptoms did not improve, so I was admitted.
(L) shoulder pain/stiffness. Pain on abduction and extension. Decreased ROM. Hurts to sleep on (L) side.
ACHES; COUGHING; SORE THROAT; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had taken cardio miracle supplement. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. Concomitant medications included artemisia absinthium herb, and copper.  On an unspecified date, the patient experienced aches, coughing, sore throat, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, coughing, headache, sore throat and fatigue was not reported. This report was non-serious.
I was extremely exhausted; tummy upset; general malaise; extremely agitated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 14:30 (Lot number: ER8727) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic fatigue" (unspecified if ongoing); "insulin resistance" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing); "chocolate allergy" (unspecified if ongoing), notes: chocolate allergy. Concomitant medication(s) included: TRAZODONE. The following information was reported: FATIGUE (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "I was extremely exhausted"; ABDOMINAL DISCOMFORT (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "tummy upset"; MALAISE (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "general malaise"; AGITATION (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "extremely agitated". Therapeutic measures were not taken as a result of fatigue, abdominal discomfort, malaise, agitation.  Additional Information: After the first vaccine patient was extremely exhausted for about two weeks after the vaccine with tummy upset and general malaise. Patient was also extremely agitated and needed to be left alone so as not to offend others. After the second vaccine, patient had a splitting headache everyday for 18 days. It is the 19th day and patient have a slight headache on the day of reporting. Patient has been sleeping 9 hours per night and she has been tired and not able to do anything, but she is not as exhausted as with the first dose. Patient has been unwell for over a month now because of the vaccine and never want to get another one. Patient did not had covid prior to vaccination. Post vaccination, patient was not tested for Covid.  No follow-up attempts are possible. No further information is expected.
Over the course of the week after injection and still continuing the reactions of dizziness, confusion, fatigue, fainting, feelings of passing out, visual disturbances, headache, pressure in the head, tachycardia, shortness of breath, intolerance to exercise and altered mood have all occurred and continue.
Rash 3-4 cm sq area (bandage reaction). Excoriated, dried ruptured vesicles. Not red, not swollen, nontender. No lymphadenitis.
Has been vaccinated in the past with Moderna. Developed sore throat, loss of taste and loss of smell.
Arm muscle soreness x1 day; Fatigue x1 day; This is a spontaneous report from a non-contactable other healthcare professional. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. On 20Apr2021, the patient experienced arm muscle soreness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events arm muscle soreness and fatigue were resolved on 21Apr2021 after a duration of 1 day.   No follow-up attempts are possible. No further information is expected.
Pt given APAP p/vax felt warm @ bedtime, had few red dots; Awake during night broke out w/whelps all over front of body, t99.4; Next day taken to Hosp poss viral;
Mild headache; This is a spontaneous report from a non-contactable healthcare professional. A 72-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via intramuscular route of administration in the left arm on 24Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced mild headache for which he took Tylenol 650mg and symptoms went away in 30 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with paracetamol 650 mg (TYLENOL). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event mild headache was resolved on an unknown date in 2021, after the duration of 30 minutes.  No follow-up attempts are possible. No further information is expected.
This patient died on 12/07/01. He went to the ER pulseless, no respiratory effort, no response to resuscitative efforts. The coroner unofficial report- SIDS. Autopsy states cause of death as SIDS.
Within 2-3 hours of being vaccinated my body was totally in pain. My left arm (vaccination site) was frozen (bent upward at the elbow). Taken to ER at Hospital, where the arm could only be pried open partially, a shoulder tap revealed septicemia and admitted to same hospital surgery on septic shoulder, blood tests showed presence of foreign substance resembling algae (pond scum). Pic line was inserted into the Pericardium of right ventricle with an antibiotic drip for approx one month, to prevent the heart from vegetating. It as the strongest anti agent a human can endure. The alternative was certain death. I was hospitalized for one month. I have not recovered.  11/02/2006 MR received from treating hospital which revealed that patient was initially seen in ER approx. 24 hours post pneumococcal vax. with c/o severe left shoulder pain and a fever of 101.4F.  She also reported a feeling of being "paralyzed" and was unable to leave her car for that 24 hour period, after which she walked to a church where 911 was called. PMH: recently dx'd hypertension, EKG evidence of past MI in 1998.  Treated with IV Vancomycin x 10 days in the hospital, then transferred to a skilled nursing facility for the remainder of her 30 days of IV antibiotics. Discharge DX: 1. Septic left shoulder joint." The cause of the septic shoulder joint remains unclear.  It was felt the injection she received was probably coincidental, as the onset was so quick and the injection should not likely have entered the synovial joint space."  2. Hypertension./pc
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 01-OCT-2015, the patient was vaccinated with GARDASIL 9, injection, intramuscularly (dose, lot #, expiration date were not reported) for prophylaxis. On 25-OCT-2016, the patient received next dose of GARDASIL injection, intramuscularly (dose, lot #, expiration date were not reported). No known adverse effects reported.