chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time; No Adverse event; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Rash in the arm; Headaches; Pain in the arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), RASH (Rash in the arm) and HEADACHE (Headaches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headaches). On 21-Jan-2021, the patient experienced RASH (Rash in the arm). On 12-Jan-2021, PAIN IN EXTREMITY (Pain in the arm) and HEADACHE (Headaches) had resolved. At the time of the report, RASH (Rash in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Approx 36 hours after vaccine administration, (L) arm is red, swollen & getting bigger. No fever. Seen at local ER & dx with localized reaction. ER prescribed BENADRYL.
Patient was given a pediatric dose of Hepatitis A prior to age 12 months. Mom was notified.  Will repeat dose at 15 months with booster 6 months after.
unable to take a deep breath, or any deep breath, with sharp pain under right shoulder blade.  Symptoms were the same as previous pneumonia episode.  also the body aches all over, somewhat severe.   Body aches lasted 72 hours with decreasing after 24.  Breathing lasted 96 hours with decreasing after 48.
Pain in deltoid; This case was reported by a other health professional via call center representative and described the occurrence of localized muscle pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 3D57E, expiry date 11th December 2021) for prophylaxis.   On 10th December 2019, the patient received Shingrix. On 10th December 2019, less than a day after receiving Shingrix, the patient experienced localized muscle pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the localized muscle pain was unknown.   It was unknown if the reporter considered the localized muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in deltoid after receiving Shingrix. The patient was treated with icepack and Tylenol, with some relief. The reporter consented to follow up. This case has been linked with case US2019226008 reported by the same reporter. The batch number was changed from 3D538 to 3D57E as per sales data sheet.
pt recv vax & & stood up & fell;pt appeared to have fainted;pulse was checked & was WNL;was monitored for approx 20min & appeared to be fine;
Right thigh-softball sized area of pruritic erythema, induration, swelling, pruritis
Admission Date: 7/12/2022 Discharge Date: 7/13/2022  PRESENTING PROBLEM: Acute on chronic heart failure, unspecified heart failure type (HCC) [I50.9] Acute on chronic congestive heart failure, unspecified heart failure type (HCC) [I50.9] COVID-19 virus detected [U07.1]   HOSPITAL COURSE: Patient is a 76 y.o. male who presents today with history of heart failure, coronary artery disease, hypertension, pacemaker in place.  Patient presented to the emergency department today because he tested positive for COVID-19 a couple of days ago.  Apparently patient's wife tested positive about a week ago and they attempted to stay away from each other but he still tested positive.  Patient stated he discussed with his cardiologist from the advanced heart failure clinic, Dr, about his COVID-19 diagnosis and was told to come to the emergency department for further evaluation due to his extensive cardiac history.  Patient does have a history of an EF of 10%.  Patient has been complaining of a mild cough and shortness of breath lasting about a last week or so.  Patient denied fevers, chills, nausea, vomiting, lower extremity edema,  sputum production. The patient was admitted observation with exacerbation of heart failure and Covid-19.   He diuresed well with IV lasix, he lost about 2 kg while hospitalized. He reported his cough improved. He had no symptoms of shortness of breath, edema, abdominal fullness. He did not require supplemental oxygen. He felt safe discharging home. Dr was consulted through the transfer center and after review of case did not feel the patient needed to be hospitalized or diuretic dosing changed. He recommended follow up with Heart Failure clinic for further monitoring. The Patient was discharged home in stable condition on his prior medications with planned follow up with Dr at the heart failure clinic on Wednesday 7/20/22. Prescriptions were sent to the patient's pharmacy for guaifenesin and tessalon perrles
Swollen, itchy and red at injection site. Flu like symptoms with fever for 24 hours after injection.
Persistent severe headache, started about 4 days after injection and have continued. He has had a negative LP and MRI.  Normal ophthalmologic exam.
This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 53-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site lump and injection site warmth. The patient was treated with Tylenol. On an unknown date, the outcome of the injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump and injection site warmth to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported, however it could be 52 or 53 years. The patient received Shingrix on left arm. The reporter noted that the patient had a lump at the injection site the size of a golf ball. The area was warm to the touch. The reporter recommended treating the area with ice and Tylenol. This was all the information that was provided for the report. This case has been linked with US2018166437 and US2018166443, reported by same reporter.
vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse regarding the 4 year old male patient.  The patient historical vaccines included varicella virus vaccine live (VARIVAX). Concomitant therapies include fluoride tablets.   On 15-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the right upper arm, lot number W030849, expiration date 06-MAR-2024) and with hepatitis A Vaccine, Inactivated (VAQTA) (administered intramuscularly at the right deltoid, lot number W028555, expiration date 17-JUL-2024). Both vaccines experienced temperature excursion.    Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. on 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes.  She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023.  The patient received immunization impacted by excursion prior to notification.  There were no known adverse events.   This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid.  This is one of three cases from the same reporter (2311USA005370 and 2311USA005371).
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: CtHg6g4) at the age of 52 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204), on 01Apr2021 as dose 2, single (Lot number: ER8727), on 04Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid from 05Jul2023 to 10Jul2023, for the treatment of COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Very severe diarrhea until tool 6 IMODIUM - took 1 every hour until 6 pm. At 4 pm got chills, nausea and felt sick. Called doctor who advised her to ride it out. Still has chills.
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles on 12-FEB-2015. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-DEC-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular outbreak, accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient was prescribed gabapentin, valacyclovir, acyclovir, tramadol, and acetaminophen and NORCO for management of painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
SWELLING AT INJECTION SITE, ITCHING, WARM TO THE TOUCH, TREATED WITH PREDNISONE, MOTRIN, AND ALLEGRA.
arm soreness - i know surprise, surprise. felt it after 4-6h mark, felt it overnight, minimal discomfort this morning; headache - mild and dull but it made me spend the evening on the couch watching tv; fatigue - definitely felt this, spent the evening watching tv and went to bed early; This is a spontaneous report from a non-contactable consumer. An adult male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in Jan2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer) in Dec2020 for COVID-19 vaccination, in left arm, dose number=1 with no reported adverse event(s). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient stated, "arm soreness - I know surprise, surprise. Felt it after 4-6h mark, felt it overnight, minimal discomfort this morning (TYLENOL did the trick), headache - mild and dull but it made me spend the evening on the couch watching TV, fatigue - definitely felt this, spent the evening watching TV and went to bed early" in Jan2021. Treatment provided for the event arm soreness included acetaminophen (TYLENOL). The outcome of the events arm soreness, headache and fatigue was recovered in Jan2021. Since the vaccination, it was unknown if the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 12 hours after vaccine I woke up with muscle aches across shoulder going up back of neck.  The next morning same thing muscles ached in back...no fever, this lasted until I went toned that might.   Next morning got up and was really tired and sleepy for about 5 hours, and then no more side effects.
This spontaneous report was received from a quality manager via field employee, refers to a female patient of unknown age. Drug reactions/allergies were unknown by the reporter. Pertinent medical history included diabetes and blood disorder. Multiple (unspecified) concomitant medication were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, injection, (lot #, expiry date, dose and frequency not reported). On an unknown date, the patient experienced shingles on her scalp after receiving ZOSTAVAX. It was not specified how long after receiving ZOSTAVAX that the patient developed shingles. The patient was still receiving unspecified treatment for a scab on her left retina. The outcome of the events was unknown. Causality assessment was not provided. It was unknown if patient sought medical attention. No product quality complaint (PQC) was involved. No further adverse event information provided. Upon internal review, scab on left retina was determined to be medically significant. Additional information has been requested.
1:23cough,scratchy mucous in trachea got candy disc but didnt help 1:25 nurse got got cold water helped 1:50 left 1:53 itchy eyes, nasal drainage-- used inhaler pressure ears and neck can feel some swelling 2:56 called dr office not in clinic 3:05 50 mg benadryl taken 3:23 left message dr  cont to have swelling 4:08 talked dr wait to start steroid 4:40 throat scratchy loosing voice,eyes swelling slightly 6:45benadryl working no further swelling
Severe pain right neck, shoulder radiating to upper arm and scapula. Persistent for several hours and recurring for several days. Immunoglobulin infusion therapy - 15 infusions. Prednisone therapy - 60 mg daily for 2 months and then tapered. Paralysis is permanent.
acute parotid gland enlargement 2hr p/vax;no fever;only on rt side spontaneously resolved over next 5 days;
JANSSEN COVID 19 VACCINE INJECTED INTO TENDON VERSUS MUSCLE; INFLAMMATORY RESPONSE TO UNKNOWN SIDE OF ARM INJECTED THAT WAS LIKE AN ORANGE ON HER SHOULDER; CHILLS FOR THE FIRST FEW HOURS  AFTER INJECTION; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced janssen covid 19 vaccine injected into tendon versus muscle. On 01-JUN-2021, the subject experienced inflammatory response to unknown side of arm injected that was like an orange on her shoulder. On 01-JUN-2021, the subject experienced chills for the first few hours after injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills for the first few hours after injection on 01-JUN-2021, and had not recovered from janssen covid 19 vaccine injected into tendon versus muscle, and inflammatory response to unknown side of arm injected that was like an orange on her shoulder. This report was non-serious.
Itching at site of injection, red. Recommend cold compresses and BENADRYL on 7/5/12. On 7/6/12 - pt. says swelling, redness decreased, area stops itching. Did not take BENADRYL.
Pt developed petechia all over his body; platelets count dec to 1,000 2wks p/getting MMR;
Fatigue, sore arm with red swollen nodule at site. Nausea, vomiting, body-aches, and headache lasting almost 3  days.
Patient experienced fever, headache, lethargy, significant brain fog - all of these lasted 2-3 days
~ 24 hours after gardasil #1, patient reports left index and middle finger is mildly swollen and difficult to bend. Vaccine was given in the same left arm.
headache; Left side shoulder blade pain/ Left side of the body pain above the waist/ soreness; Neck pain; Injection site redness; Pain/ injection site pain; Rash / Injection site rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included paracetamol (Tylenol).   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th August 2019, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site rash. On an unknown date, the patient experienced headache, shoulder blade pain and neck pain. On 16th August 2019, the outcome of the injection site erythema, injection site pain and injection site rash were recovered/resolved. On an unknown date, the outcome of the headache was unknown and the outcome of the shoulder blade pain and neck pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site rash, headache, shoulder blade pain and neck pain to be related to Shingrix.  Additional details were reported as follows: On 16th August 2019, the patient received the 1st dose of Shingrix on left delotid via intramuscularly and she experienced injection site redness, pain, and rash which were started about 2 hours after the vaccine and lasted for only 4 hours. The patient also experienced general adverse reactions like left side shoulder blade pain, neck pain, left side of the body pain above the waist. This events also resolved in a few hours. The patient was a diagnosed with arthritis for which she was taking Tylenol. The reporter consented to follow up.
THE PATIENT CAME IN TO THE CLINIC ON 07/10/2021 TO RECEIVE THE BOOSTER DOSE OF PFIZER. WHEN DOCUMENTING THE VACCINE, WE NOTICED THAT A MISTAKE ON DOCUMENTING THE FIRST DOSE OF PFIZER WAS DONE. ON THE SYSTEM WAS DISPLAYED THAT THE PATIENT RECEIVED A DOSE OF J&J ON 06/20/2021 INSTEAD OF THE DOSE OF PFIZER THAT SHE ACTUALLY RECEIVED ON THAT DATE.
This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with M-M-R II [Lot# L019488, Expiry date: 11-FEB-2018, Lot# K014833, Expiry date: 14-SEP-2016, Lot# L001336, Expiry date: 13-JAN-2017, Lot# L012479, Expiry Date: 10-APR-2017 and Lot# L007217 Expiry Date: 03-MAR-2017] which were exposed to temperatures outside of the recommended range. No adverse event were reported. This is one of the several reports from the same reporter. Additional information has been requested.
pt recvd vax;arm sore next am;about 10am soreness & swelling noted at inj site;about 4pm noticed swelling all around upper arm; elbow very hot & painfull;seen at prime care;given lodine for pain;told to use sling;apply ice for swelling;
Myalgia, Fever, NauseaVomiting, faitgue, chills Narrative:
Large red knot with swelling, and rash growing in irregular size around injection site. Extreme soreness, child cries out in pain when area is touched. Warm skin at injection site.
Patient presented to health center for different reason and in conversation related that she had an episode of fever with vomiting at 2AM the following morning post immunization. No further reactions noted.
Got Shot one Thurs, Sat following (same week) woke up with a sore throat that hurt.
Severe L arm pain and unable to move it for 2 days and then feels has had Bilateral shoulder, knee, ankle and low back pain since getting the vaccine 1/28/19.
five expired doses were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (five expired doses were administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (five expired doses were administered). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (five expired doses were administered) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided.   No treatment medications were provided.   This case was linked to MOD-2021-354310 (Patient Link).
Pt vaccinated w/DTP cried inconsolably for greater than 3 hrs & most of day, temp 102.