chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of radiating pain in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced radiating pain and drug dose administration interval too short. On an unknown date, the outcome of the radiating pain and drug dose administration interval too short were unknown. It was unknown if the reporter considered the radiating pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient care of anecdotal evidence of pain radiating from armpit to breast. The reporter tried to do patient education but could not find that this type of pain was a known side effect of SHINGRIX, which began after 2nd dose given by pharmacy 35 days after 1st injection, which led to which led to the shortening of the vaccination schedule. The reporter seeking information you can provide so I can reassure patient symptoms were transient.
Patient fell faint, tingling in legs, felt numb B/P 110/60 P 40 monitored patient left after 20 minutes.
Behavior changes: 1. Confusion -lasted all evening see below. A. Loss of time as related to events 5pm. B. Frustration 6pm. C. Anger 6:30pm.
Per caller another Medical assistant pulled the needle out of a patient because they moved then accidental squirted it in another medical assistant eye.; This spontaneous report was received from a healthcare business professional and refers to a female patient (medical assistant) of unknown age. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 07-JUL-2022, the patient was accidentally squirted in the eye with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) by another medical assistant who was pulling the needle out of a patient, patient was being vaccinated for prophylaxis, because they moved (occupational exposure to product). Medical assistant has flushed her eye several times and had not reported any issues at the time of report.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002610:
My brother has epilepsy. His seizures can be triggered by low grade fever and exhaustion. He had covid in early October. His seizures are generally well controlled but he had several after the vaccine. I understand that the vaccine did not cause the seizures. The fever caused the seizure. I just think it?s important to neurologists to have this info to see how we can go about mitigating the seizures and if the 2nd dose is necessary. Keeping him hydrated may have helped and also giving him something immediately for the low grade fever. Just knowing these things may help others.
1/8/13 at 6PM, mother noticed patient's right thigh was red, swollen, and hard to the touch. Gave MOTRIN to patient. At the time mother called on 01/10/13, symptoms were improving.
COUGH, Fatigue, Muscle or body aches, Headaches, Congestion or runny nose, and Nausea or vomiting
Initial unsolicited report received from a consumer on 15 October 2015. This case involves a [age unknown] female patient who was vaccinated with a [route and dose in series were not reported] dose of FLUZONE HD [batch number, expiry date and site of administration were not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced dark, bloody stool. Lab data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
Pt developed a high fever of 104F on 11/07/01. She was lethargic on 11/10/01 with a rash and lethargic on11/11/01 with tremors.
Arm swollen from shoulder to elbow across elbow joint within 48 hours.  Swelling lasted over 1 week.  Within 48-72 hours after immunization acquired symtoms that were "flu-like"-fever, joint pain, muscle pain headache, lethergy.  Fever subsided other symptoms continue to date with occasional low-grade idiopathic fever.
Initial fatigue, nausea and lightheadedness at 3:00 PM, onset of muscle aches at 6:00 PM, on 9/17 woke up with severe headache, muscle ache, nausea and fever of 101 degrees.  Symptoms unchanged throughout day of 9/17.  9/8 which was day 2, woke up without fever but ongoing muscle ache, slight headache, fatigue.  9/19, today, only light muscle ache, no fever, slightly sweaty, fatigued.
Patient was given overdose of vaccine. When reconstitution took place the Diluent  mixed in was too little. Patient has not reported any adverse symptoms
pt recv 2nd dose vax JUN97 & 18JUL97 pt was inadvertently given a 3rd dose of vax & devel a fever of 100.2;
Brain fog; Loss appetite; Pain in injection site (right); Fatigue; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CALCIPOTRIOL (DOVONEX) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Mar-2021 at a dose of 2 doses. On 07-Mar-2021, FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved. On 09-Mar-2021, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was recommended for second dose on 30 March 2021.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Added concomitant medication and amended narrative.
achy knees and ankles,  low grade fever and chills.  onlu lasted about 3 hours
Well child visit on 03/24/2005 @ 9:30 shots included Pediarix, HIB, and Prevnar. Pediarix in left thigh, Hib and Prevnar in right thigh. At home, cried for 4 hours and decreased feeding, then noticed lethargy for 12 hours.
pt recvd 3 doses of Engerix-B & had a neg titer following the 3rd dose; pt then recvd 3 addtl doses & devel protective titers following the 6th vax;
rebound Covid case followed; rebound Covid case followed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 10Jun2022, outcome "recovering" and all described as "rebound Covid case followed". Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical course: vaccine received. No other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tested COVID positive with mild symptoms over next days; This is a spontaneous report from contactable consumer or other non healthcare professional via Pfizer sponsored program. A 99-years-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Jan2021 as single dose for COVID-19 immunization. Medical history included kidney and breast cancer survived after surgeries. The patient's concomitant medications were not reported. On 25Jan2021, patient tested COVID positive with mild symptoms over next days. On 25Jan2021, patient underwent lab tests and procedures which included covid-19: positive. On 29Jan2021, patient received infusion monoclonal antibodies followed by much worsening of symptoms. Gradual improvement within a month had strength and stamina back decided against getting second dose scheduled on 07Feb2021. Reporter wanted to know if patient should she get her second vaccination and when. Reporter also wanted to know if had any information about how long to wait to get the Pfizer vaccine after receiving monoclonal antibodies. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Nurse reported that, on 12-SEP-2013, the patient received the second dose of GARDASIL (dose, lot number and route were not reported) late. Nurse reported that the first dose of GARDASIL (dose, lot number and route were not reported) was given on 08-SEP-2011. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Extreme soreness on right arm for two weeks compared to the amount of soreness I felt on the left arm from the flu shot. Sharp pain, burning and numbness in right arm extending into right hand for the last two months.
she had a sore arm; Headache from hell; Neck pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included cervical spinal stenosis. Concomitant medications included: nortriptyline, 50mg daily. On an unspecified date, the patient experienced headache from hell, neck pain after Covid 19 shot (first shot). She said next day her headache was gone and neck pain was completely gone, which she said is unusual because she normally has neck pain every day from her cervical spinal stenosis. She said the day after the shot, she had a sore arm. The outcome of the events headache from hell and neck pain was recovered while for the other event it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received Pediatric Pfizer dose in left  deltoid.  She then received Flucelvax in right deltoid.  Upon receipt of 2nd vaccine, patient fainted and lost consciousness for a few seconds.  She quickly woke up, had a snack, and recovered.
100.7 Fever persistent for two days, body ache, injection site sensitivity, mild headache
A knot in the arm swelled up immediately after injection. It bled moderately but the swelling would not go down. It was a soft knot about the size of a cherry.
Moderna COVID-19 Vaccine EUA:  Muscular and joint aches started about six hours after injection.  At 5:00 am following morning I took 800mg Ibuprophen and an hour later was relieved of a good amount of the pain.  Joint aches seemed to be gone by 6:00, making the duration of the side effects about 24 hours.
suspected vaccination failure; He gave his wife the shot and. She got it!!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The reporter stated that the physician gave his wife the shingles shot and she experienced shingles. The physician gave her the Anti Viral Shot to help her and it went away. This case was considered as suspected vaccination failure since the details regarding the dose number, time to onset and laboratory confirmation of shingles was not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100411:same reporter
No adverse event; 11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medication information was provided. Reporter mentioned that no AEs were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391, US-MODERNATX, INC.-MOD-2022-662390, US-MODERNATX, INC.-MOD-2022-662385 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662390:same reporter US-MODERNATX, INC.-MOD-2022-662385:same reporter US-MODERNATX, INC.-MOD-2022-662391:same reporter
Coughing, wheezing and shortness of breath along with accelerated heart rate. I developed hives on the injection site arm.
This was an employer provided flu shot.  Symptoms were body chills (extreme cold), headache, fatigue, dizziness. Symptoms onset roughly 6 hours after shot and resolved after 12 hours.
began to feel pressure on and around her eyes; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (began to feel pressure on and around her eyes), CHILLS (chills) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Influenza vaccine.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced CHILLS (chills) and HEADACHE (headaches). On 10-Apr-2021, the patient experienced OCULAR DISCOMFORT (began to feel pressure on and around her eyes). At the time of the report, OCULAR DISCOMFORT (began to feel pressure on and around her eyes), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.             .   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021, No significant information was received.
she gets a cough every time she gets a Covid shot or vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Medullary thyroid cancer" (unspecified if ongoing), notes: Medullary thyroid cancer History of Medullary Thyroid Cancer; had Thyroid Removed; "Ulcer" (unspecified if ongoing), notes: she does have an ulcer and esophageal ulcers history; "esophageal ulcers history" (unspecified if ongoing), notes: she does have an ulcer and esophageal ulcers history; "Blood Pressure" (ongoing); "Migraine" (ongoing); "Covid", start date: Feb2020 (unspecified if ongoing); "bilateral pneumonia" (unspecified if ongoing); "influenza" (unspecified if ongoing); "Flu" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal (ongoing); SYNTHROID taken for medullary thyroid cancer (ongoing); TOPAMAX taken for migraine (ongoing); BYSTOLIC (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot no.: EW0153), administration date: 05Apr2021, for Covid-19 immunization, reaction(s): "she gets a cough every time she gets a Covid shot or vaccine"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot no.: EW0171), administration date: 26Apr2021, for Covid-19 immunization, reaction(s): "she gets a cough every time she gets a Covid shot or vaccine"; Flu shot, administration date: 2022, for Immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "she gets a cough every time she gets a Covid shot or vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the reporter states she also has a weird cough, states she gets a cough every time she gets a Covid shot or vaccine.
I felt muscle weakness, dizziness and fatigue. I laid down to deal wit the symptoms.
shingles; Information has been received from a lawyer and a patient 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 31-MAY-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient 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 event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Incorrect diluent volume resulting in higher than authorized dose. No immediate reactions noted. Patient informed by phone of medical error. No symptoms at this time but discussed potential adverse reactions with patient.
Grandmother called 1-9-2012 to report child developed swelling of tongue and lips on 1-5-2012.  She denied any difficulty breathing, or syncope.  Patient has a sports physical exam 1-5-2012, symptoms not noted until approximately 6:30pm. Grandmother described a nickel size area of redness and swelling at injection site, Benadryl spray applied, symptoms resolved within 4 hours.  Swelling of lips and tongue completely resolved 1-9-2012 morning per Grandmother.  Child was not taken to ED or PCP for medical evaluation, nor mentioned this to MD during her sports physical.
injury/They give me a tetanus shot seven days after my first dose of Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "injury/They give me a tetanus shot seven days after my first dose of Covid vaccine". Therapeutic measures were taken as a result of injury.  Additional information: Reporter stated because of an injury, they give them a tetanus shot seven days after my first dose of Covid vaccine. Reporter got the Covid-19 vaccine, the first dose last week about 7 days ago and today a weak after first dose of the Pfizer Vaccine reporter was given a tetanus shot and it was known to the reporter under CDC website, it says to wait 14 days between the Covid vaccine and any other vaccine so reporter wanted to know what should be done. Lot and expiration date of vaccine, reporter stated, the card was not with reporter right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site on left arm developed a red rash,  kind of like a welt  , raised read and sometimes itchy.  started day 8 after shot and lasted 12 days.