chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported getting some bumps on her back a day or so after receiving the Shingles vaccination. She states that she got the same type of reaction upon receiving the first shot in the series and her physician told her to use a warm compress and the bumps went away after several weeks. On this occasion, her physician prescribed valacyclovir 1 gram to be taken 3 times a day for 7 days with a diagnosis of zoster without complications B02.9.
Patient developed a burning sensation in right armpit within an hour after receiving vaccine. Two hours later developed a lump in the same area. By the next morning the lump was the size of a golf ball. He was evaluated by Work-Med and referred to personal physician. Personal Physician did not symptoms were related to the vaccine. He was treated with an antibiotic.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 14-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", lot # L007720 with expiration date of 08-JUL-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 168 hours, where the lowest recorded temperature was 1 F (1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1 F (-1 Celsius degree) and 0 (0 Celsius degree), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
her arm started bothering again; warm; bump; red; it itches; it hurt; her arm a little bit swollen; Tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen) and VACCINATION SITE PAIN (Tender) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender) and VACCINATION SITE PAIN (it hurt). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (it itches). 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (bump). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5: Moderna /Dose Number: 4 :Pfizer/Dose Number: 3 :Pfizer/Dose Number: 2 :Pfizer/Dose Number: 1 :Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Sep2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022 at 09:00, outcome "unknown", described as "Dose Number: 5: Moderna /Dose Number: 4 :Pfizer/Dose Number: 3 :Pfizer/Dose Number: 2 :Pfizer/Dose Number: 1 :Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound symptoms of COVID-19, with a positive antigen test; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. anti viral details treatment start date 22Sep2022 and stop date 27Sep2022.  Clinical information: Patient took other medication in 2 weeks   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received no other medication in 2 weeks. Anti-viral details: [product=COVID 19 Treatment].  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Topical swelling at the injection site left arm. "Pass out" per babysitter for 3 minutes, after 24 hours of immunization placement. Treatment: hydrocortisone topical cream 1%, hydramine liquid (antihistamine) 1/2 tsp Q 6 hours. Tylenol soft chew.
No adverse event; HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later) 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 EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734665 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734665:Same Reporter ,Patient 2
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
Day 2 Chills Muscle Aches through entire body including fingers and toes Headaches Nausea Temperature 102.4 Completely  unable to move and take care of my children   Day 3 Headaches Arm Swelling all the way under armpit Red and Warmth under skin at injection site
shingles; other zoster-related conditions; Information has been received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 17-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot#, expiration date and route were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the pt was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered as not recovered. Causality between the events and zoster vaccine live (ZOSTAVAX) was related.
Patient stated it swelled significantly at injection site, today she has a bruise from just below site to elbow 75% of arm. Stated she felt not well, run down.
Granddaughter describes patient having a high grade fever (104.2) within 24 hours of receiving vaccinations. Over the course of 3 days, patient became lethargic, stopped eating/drinking, and started to become mentally confused. Patient admitted to emergency care on 11/12/23 due to declining health and continual high grade fever.
This case was reported by a other health professional via call center representative and described the occurrence of chills in a 58-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. Co-suspect products included ADACEL (batch number C5467BA, expiry date 20th June 2020) for prophylaxis. Additional patient notes included None. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and ADACEL. On 2nd July 2018, 4 days after receiving SHINGRIX, the patient experienced chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea. The patient was treated with benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the outcome of the chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea were recovered/resolved. The reporter considered the chills, electric shock sensation, injection site pain, injection site erythema, headache and diarrhea to be almost certainly related to SHINGRIX. Additional details were provided as follows: No medical history or allergies were reported. The patient received SHINGRIX and ADACEL in the right deltoid. The patient experienced chills, headache, diarrhea, injection site soreness and redness, and an electric feeling in her left toe and right temple. The reporting medical assistant stated that there was a doctor visit required at the office, and that the patient took Benadryl and Tylenol. The patient's symptoms had since resolved. The reporting medical assistant stated that the physician believed the patient's symptoms were most likely related to SHINGRIX, and that the patient might had been an emotional response to the vaccine in relation to the electric feeling that the patient experienced.
Patient had intermittent episodes of non billious, no bloody vomiting 24 hours after vaccinations. No diarrhea and no decrease in wet diapers. Symptomatic treatment including Pedialyte.
got the flu; allergic to egg; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious health care professional.  This case involves unknown age of patient who got the flu (Influenza) and allergic to egg (Allergic reaction to excipient), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported who got the flu (Influenza) and allergic to egg (Allergic reaction to excipient), (non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for flu, allergic reaction to excipient, at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported.
Small tender lump over collarbone; Small tender lump over collarbone; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 11May2021 at 13:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Other medical history was not reported. Concomitant medications taken within two weeks of vaccination included paracetamol (TYLENOL) and ibuprofen (ADVIL); both from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0162), via an unspecified route of administration in the right arm on 20Apr2021 at 13:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, the patient experienced a small tender lump over collarbone. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event small tender lump over collarbone was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt recv  vax on 3/6/99; 3 hr post vax pt exp fever, chills, shaking; tx=Motrin
Patient reported that she received the Johnson and Johnson (your website does not allow for input of this or any vaccine not listed by the drop down menu so I had to enter as one of those) covid-19 vaccine in April 2021. She stated the next day she had ringing in the ears, hot flashes , the room was spinning, had severe migraines, and had flare-up of her asthma symptoms. She stated that all symptoms outside of the migraine and asthma symptoms resolved after a few days. The migraines lasted about 2 weeks and her worsened asthma did not resolve until 6 to 8 months later after being on Dupixent for that same amount of time. She asthma which got worse as time went on..
skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst; skin on the arms and legs and the back of the shoulders are scarred; The skin on arms and legs and the back of shoulders breaks out; This spontaneous case was reported by a patient and describes the occurrence of DERMAL CYST (skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst), SCAR (skin on the arms and legs and the back of the shoulders are scarred) and RASH (The skin on arms and legs and the back of shoulders breaks out) in a  patient of an unknown age and 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, the patient experienced DERMAL CYST (skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst), SCAR (skin on the arms and legs and the back of the shoulders are scarred) and RASH (The skin on arms and legs and the back of shoulders breaks out). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, DERMAL CYST (skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst), SCAR (skin on the arms and legs and the back of the shoulders are scarred) and RASH (The skin on arms and legs and the back of shoulders breaks out) had not resolved.            No concomitant medications were reported.  The patient visited the physician and informed them about the patient's condition, and they only kept on giving the patient with a prescription strength hydrocortisone, but the patient reported that the medication did not work. The patient reported that it had been more than a year since the events happened, as if the patient's body was trying to reject whatever constituent was there in the vaccine.  These cysts form sometimes daily or weekly. The patient had tried everything in order to reduce it.
Severe flare up of my IBS and my Rheumatoid Arthritis; Severe flare up of my IBS and my Rheumatoid Arthritis; Severe stomach aches; Nauseous; Severe joint and muscle pain; Severe joint and muscle pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Dec2021 09:00 (Lot number: FF8839) at the age of 48 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "IBS" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Mar2021, when the patient was 48 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021 09:00, outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant), IRRITABLE BOWEL SYNDROME (non-serious), outcome "not recovered" and all described as "Severe flare up of my IBS and my Rheumatoid Arthritis"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Severe stomach aches"; NAUSEA (non-serious), outcome "not recovered", described as "Nauseous"; ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "Severe joint and muscle pain". Therapeutic measures were not taken as a result of rheumatoid arthritis, irritable bowel syndrome, abdominal pain upper, nausea, arthralgia, myalgia.  Additional information: it was reported that the patient had a severe flare up of IBS and Rheumatoid Arthritis. She also had severe stomach aches, severe joint and muscle pain.  No follow-up attempts are possible. No further information is expected.
MUSCLE PAIN; SORE AT SITE OF INJECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced sore at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle pain, and sore at site of injection on 07-MAR-2021. This report was non-serious.
Client received the COVID vaccine (Moderna, 1st dose, lot #041AB21A, exp. 5/6/2021) at (time). Client reported itching and burning in her arms, and intermittent itching all over her body. EMT and RN responded at 1120. The client denied any difficulty breathing and had no swelling around her mouth or tongue. She stated that she was vaccinated at 1045 and she started to experience itching at 1100. The client denied any medical conditions or any regularly prescribed medications. She stated she is allergic to penicillin, sulfa, voltaren, and trees. At 1125, the client's vital signs were as follows: blood pressure 130/78, O2 94%, heart rate of 51, and respiratory rate. She refused benadryl but accepted some water. At 1130, the client's blood pressure was 114/72. At this time she stated that her symptoms were resolved and left against medical advice, before her 30 minute wait was over. Education provided regarding emergency response and AMR activation, and primary care follow up. Client was escorted to her car and she had a friend drive her home. She ambulated out of the facility with a steady gait.