chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. received Varivax 6/21/10.  On 6/22/10 pt had area of redness at injection site which was size of an orange.  Pt. called HD on 6/23/10 and stated redness now size of grapefruit.  Pt. referred to her MD.  Seen by MD on 6/24/10. Pt told to take Benadryl and ice area and not to receive second Varivax.  MD did not think infection present, that redness was severe local reaction to vaccine.  TC to pt. on 6/25/10, and pt. states redness is starting to subside.
blood clot after taking the first dose; This is a spontaneous report from a Pfizer sponsored program. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021, as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced blood clot after taking the first dose and was just advised to take the second dose by her Doctor. Caller wanted to make an appointment for the patient's second dose. Caller refused to be transferred and will talk to his friend and Doctor first. The outcome of the event was unknown.  Follow up attempts are needed. Information about batch/lot number has been requested.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
patient over the age of 25 in college received 1 dose of the bexsero.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported but could be more than 25 years as the patient's age was reported as over 25 years. The patient received a dose of the Bexsero at this age, which led to inappropriate age at vaccine administration. The reporter did not have further details.  No reactions reported. The reporter did not consent to follow up.
SHARP PAIN TO ABDOMINAL AREA ON  BOTH SIDES; RIGHT LEG PAIN (THIGH); This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced sharp pain to abdominal area on both sides. On 13-APR-2021, the subject experienced right leg pain (thigh). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain to abdominal area on both sides, and right leg pain (thigh). This report was non-serious.; Sender's Comments: V0: medical assessment comment not required as per standard procedure as the case is assessed as non serious.
pt presented self on 29OCT96 c/o pain to rt arm p/vax given;14AUG96 pt can't grasp things w/finger & also states has a lump to site upon inspection no lump felt;sent to clinic for eval;
45 Days post First Vaccine, No Second Dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided.   This case was linked to MOD-2021-108572 (E2B Linked Report).; Sender's Comments:  MOD-2021-108572:crosslinked to Wife case
It was reported that a 39 year old male pt received IPOL and HEP-B (2nd dose) on 6/11/99 for travel. The pt started with "severe pain and burning in all four limbs and trunk, tremors, fatigue" on 6/17/99. Dx'd as small fiber neuropathy. Pt was treated with Prednisone. The pt had received other travel vaccines on 5/5/99. Pt was evaluated at hospital. New being followed at another hospital. Reportedly, modified work schedule. Pt under care of a Neurologist. Further information is requested.
pt with history of anaphylaxis to latex and fruit, presents to ED with urticarial skin reaction with itching, throat itching, cough, lightheadedness soon after receiving Covid vaccine.
This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 10-JUN-2016, the patient was vaccinated subcutaneously with an expired dose of M-M-R II (lot # M001200, expiration date: 28-AUG-2016, dose was not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Erythema multiforme (minor). 1 week after injection patient developed classic painful papular targetoid lesions on the palms, soles, distal extremities with no recent episode of herpes labialis. Patient was otherwise well and rash is self-resolving after ~2 weeks
Doctor spoke with dad on phone. Several hours after shots, babysitter noted child's face was with unusual gesture (grimace). Dad thought explanation seemed like a convulsion. No LOC, no fever. Taken to ER.
sick as a dog; hasn't been able to get out of bed; received a full dose instead of a half dose  for the booster.; hard to walk; restless; wasn't able to sleep; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (hard to walk), RESTLESSNESS (restless), INSOMNIA (wasn't able to sleep), ILLNESS (sick as a dog) and MOBILITY DECREASED (hasn't been able to get out of bed) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 011A21A and 043A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 28-Oct-2021, the patient experienced GAIT DISTURBANCE (hard to walk), RESTLESSNESS (restless), INSOMNIA (wasn't able to sleep), MOBILITY DECREASED (hasn't been able to get out of bed) and ACCIDENTAL OVERDOSE (received a full dose instead of a half dose  for the booster.). On 29-Oct-2021, the patient experienced ILLNESS (sick as a dog). On 28-Oct-2021, ACCIDENTAL OVERDOSE (received a full dose instead of a half dose  for the booster.) had resolved. At the time of the report, GAIT DISTURBANCE (hard to walk), RESTLESSNESS (restless), INSOMNIA (wasn't able to sleep), ILLNESS (sick as a dog) and MOBILITY DECREASED (hasn't been able to get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. patient does not take any medication.  No treatment medications were provided.
I now have covid pneumonia; I was covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (I now have Covid pneumonia) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (I was covid positive). On an unknown date, the patient experienced COVID-19 PNEUMONIA (I now have covid pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (I now have covid pneumonia) and COVID-19 (I was covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
As soon as I received it, about 2 minutes after, it was a drive thru event and my mom was also with me in the car receiving the vaccine also. I was still waiting for the nurse to replace her bandaid since she was bleeding a little more than normal. As soon as the car got out of the tent, I was driving, it felt like my head was being drilled, my vision blurred, everything turned dark, I could not hear, I had a bad headache almost about to faint but I kept on driving slowly to get to the waiting area. By the time I parked, I removed my mask, open the car window and relaxed and just started inhaling deeply.  I felt better soon after and spoke to the nurse there and she recommended drinking fluids the next 48 hrs.  I felt dizzy,  tired but not very sore like the first dose.  2 days later, I still feel dizzy, vision is blurry sometimes and occasional headache, a little tenderness on abdomen and feeling like I am catching my breath sometimes.
When I first took the Covid vaccination I had no symptoms then later that day  into the next morning about 1-2 am 3/12/21 started feeling fever, chills, headache, body aches, restlessness weak. Later the same day no appetite. Made myself eat so I could take some tylenol for fever and pain.
Suspected vaccination failure; a possible adverse event of shingles in a patient after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The pharmacist reported a possible adverse event of shingles in a patient after Shingrix. The reporter asked if the patient get shingles from the Shingrix shot and conservatively recorded the adverse event. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure, since the details regarding the dose number, time to onset for event and laboratory confirmation for shingles were not provided.
A few hours after I received the vaccine, my arm broke out in a rash and was extremely sore. However, this disappeared in two days. On 8/9/21, it came back but much, much worse.  It was very large covering most of my upper arm, warm to the touch, and was severely itchy. It lasted until the 13th, but still had a small outline of redness. I also had another adverse event which was much more severe, but it started on a different date and the form would not let me choose two dates. I will try to fill out another form for this one.  Just in case it does not let me do this, I will mention it here. On 8/12/21, I woke up to find my right eye had severe hemorrhaging. I took pictures and sent it to a nurse practitioner and my eye doctor.  As of today, it is still there, but is improving slightly.  I had a Teladoc appointment with my eye doctor and will going to see them tomorrow. I am also going to speak to my Family Doctor tomorrow as well.
This is a pregnancy case. This female subject was enrolled in a study. The subject received the 2nd dose of FLUARIX QIV on 12th November 2014. Previously administered products included FLUARIX (1st dose while pregnant). On an unknown date, an unknown time after receiving FLUARIX QIV the subject developed extra dose administered (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of extra dose administered was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy outcome was unknown. Additional information received: 2nd dose of FLUARIX QIV given in same season to a pregnant patient (1st dose given 9/2/14).
FluMist administered on morning of 10/21/2009. Developed fever, body aches, nausea, and fatigue beginning at afternoon/evening of 10/21/2009. Symptoms resolving on 10/23/2009. Also receiving seasonal influenza vaccination and PPD test at same time. No tobacco use. Social alcohol - none.
Pt given 1 dose of FLUZONE (.5). Pt upper arm became blotchy, arm was sore. After time arm blotches clear. Pt complain of dif raising arm.
Tingling left side of body, blurry vision, pressure behind left eye, foggy, dizzy, fatigued, hard time catching breath.
chills; fever; muscle aches (entire body).; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), via an intramuscular route of administration in the right arm on 07Apr2021 at 08:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and insomnia. Concomitant medications included trazadone 100 mg SID (MANUFACTURER UNKNOWN) and levocetirizine SID (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an intramuscular route of administration in the right arm on 17Mar2021 at 08:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. On 07Apr2021 at 23:30, 14 hours post injection, the patient experienced chills, fever and muscle aches (entire body). On an unspecified date, the patient received oral TYLENOL as needed as treatment for the adverse events. The clinical outcomes of the events chills, fever and muscle aches (entire body) was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Canker sores inside her mouth; Small shingles reaction; This is a spontaneous report from a contactable consumer, the patient. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0153; NDC number and expiry date: unknown) via an unspecified route of administration on 14Apr2021 at 18:40 in left arm as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included tick bite that was undiagnosed until 2000. The patient previously took antibiotics (NDC, lot number and expiration date not available) for chronic lyme's disease and the reaction had stuck around. Patient took antibiotics late in the game. When patient was a child, she had no reactions on getting vaccines. The patient's concomitant medications were not reported. Patient took flu vaccine (NDC, lot number and expiration date not available) in early 2000s that seemed to give her flu. On 24Apr2021 (10 days later), the patient experienced small shingles reaction and she was concerned because she never had shingles before. She also had some canker sores inside her mouth. She did not know if they were related as she was getting some dental work. She was not hospitalized for the events and did not require emergency room and physician office visit. She was scheduled to receive the 2nd dose of the COVID-19 Vaccine on 05May2021. However, she said her doctor told her to get the shingles vaccine (Shingrix). Patient took lot of heavy-duty Vitamin D3 and amino acid lysine to help her immune system and thus shingles did not get severe. The vitamins cleared up the shingles with no complications. Relevant tests were not reported. Event shingles recovered on 30Apr2021 while outcome of the event canker sores was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515261 same reporter/drug/AE, different patient;US-PFIZER INC-2021515262 same reporter/drug/AE, different patient
she is feeling in the left side of her back the same reaction she felt in the arm before having a; Injection site started itching a lot; Injection site started getting red; like if she had hives; rash; a little worried; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site started itching a lot), VACCINATION SITE ERYTHEMA (Injection site started getting red), URTICARIA (like if she had hives), RASH (rash) and ANXIETY (a little worried) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started itching a lot), VACCINATION SITE ERYTHEMA (Injection site started getting red), URTICARIA (like if she had hives), RASH (rash) and ANXIETY (a little worried). On an unknown date, the patient experienced RASH (she is feeling in the left side of her back the same reaction she felt in the arm before having a). At the time of the report, VACCINATION SITE PRURITUS (Injection site started itching a lot), VACCINATION SITE ERYTHEMA (Injection site started getting red), URTICARIA (like if she had hives), RASH (rash) and RASH (she is feeling in the left side of her back the same reaction she felt in the arm before having a) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Initial symptoms include worsening fevers, fatigue, and muscle weakness that required hospitalization since 11/30/15. Currently still hospitalized at this time with pending inpatient rehab facility placement.
Vaccine given in Left deltoid - swelling and redness. Area approx 7 in x 7 in. Hot to the touch. Pt has applied ice packs and taken BENADRYL for swelling.
She thought that they put more dosages in her body; Feeling horrible; Body aches; Fever; Chills; A spontaneous report was received from a physician concerning his wife,a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a thought that they put more dosages in her body, fever, chills, body aches, feeling horrible.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On 4 Feb 2021, The patient thought they put more dosages in her body. the patient also experienced the event(s) fever, chills, body aches and was feeling horrible.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The event she thought that they put more dosages in her body-was resolved on 04 Feb 2021. The outcome of events- fever, chills, body aches, feeling horrible were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 16-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.