chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to a 25 year old patient. The patient's medical history and current conditions were not reported. On 13-NOV-2014 the patient was vaccinated with the first dose of GARDASIL and an early second dose on 13-NOV-2014. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
swelling of lymph nodes; loss of hearing in right ear; right ear began to feel full with pressure/pain; right ear began to feel full with pressure/pain; dizziness; vertigo; ringing in right ear (tinnitus); This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 20Apr2021 (Lot Number: EW0171) (at the age of 26-year-old) as single dose for COVID-19 immunisation.  Medical history included non-alcoholic fatty liver disease, allergies, asthma, autism, sensory integration disorder, appendectomy, pilonidal cyst removal, all from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  The patient previously took penicilline, tetracycline, amoxillin [amoxicillin sodium] and hydrocodone.  The patient experienced dizziness/vertigo within a couple of hours of first vaccine on 20Apr2021. Developed ringing in right ear (tinnitus) on same day. By 21Apr2021, right ear began to feel full with pressure/pain. All symptoms continued with swelling of lymph nodes and loss of hearing in right ear by 22Apr2021. The events were assessed as serious, disabling. The patient saw otolaryngologist (ENT) for hearing test and evaluation on 27Apr2021, hearing test showed substantial loss of hearing in right ear. Steroids were prescribed and taken. The patient underwent lab test and procedures which included magnetic resonance imaging (MRI): unknown results on an unspecified date. Dizziness/vertigo either resolved on 29Apr2021. The patient outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
from patient directly:  had the rsv vaccine ..no pain in the immediate are of the shot..but within 24hrs I developed a wheezing cough and the mucus I'm coughing up is clear but I haven gotten rid of it..no fever and I took a covid self test yesterday that was negative
Rash in the Rt arm site area of V-VAX given 04/27/16.
Left injection soreness (3/12/21) Right knee pain where replacement is (3/14/21). Right hip pain where replacement is(3/14/21). Right scapular pain (3/14/21). Bilateral hand coldness (3/14/21. Taking Naproxen 220mg 1 tablet daily since 3/14/21.
the Patient was given 0.2ml dose without dilution, patient received higher dose, 28mcg instead of 10mcg
Vaccine administered 3/17/04. On 3/25/04 patient had fever (104 degrees). On 3/26/04- patient had rash. On 3/24/04 patient had sore throat and ear infection. On 3/25/04 patient had diarrhea.
Fatigue extreme, fever, Headache, nausea and vomiting, diarrhea.
Large, raised, hard red welt x2 days so far.  3" x 2".   Extremely painful.  Very hot at welt.  Chills, body aches, full body pain, feverish,  sensitivity to cold, all over weakness.
ACHES; CHEST PAIN; FEVER; SORENESS AT INJECTION SITE; STIFFNESS; WEAKNESS ON THE ENTIRE LEFT SIDE OF BODY; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 196 pounds, and height was 63 inches. The patient's concurrent conditions included sulfas allergy, penicillin allergy and alcohol consumption. The patient does not smoke and does not have any drug abuse or illicit drug usage. The patient stated that she has a general good health.  The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left deltoid on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced weakness on the entire left side of her body. On the same day, the patient experienced stiffness, fever, and soreness at injection site and also recovered from the left side body weakness. On 23-MAR-2021, the subject experienced aches and chest pain. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from weakness on the entire left side of body on 22-MAR-2021, was recovering from soreness at injection site, aches, stiffness, and chest pain, and had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345029-Covid-19 Vaccine Ad26.Cov2.S - Weakness On The Entire Left Side Of Her Body. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
day after vaccination pt experiencing leg severe muscle pains, pt is not able to move much without using a walking stick, and has to have assistance to get around
Pt recv vax on 7/26/96; on 4/20/99 pt exp chicken pox
4.5 in diameter erythematous plaque to right upper arm, warm to touch and tender to touch.
acquired covid19 had mild to moderate symptoms; acquired covid19 had mild to moderate symptoms; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated 2 and a half weeks ago and a week ago, in Jan2021, she acquired Covid19 had mild to moderate symptoms. Event was reported as non-serious. The physician wanted to know when the 2nd dose should be given. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt was ambulating through hospital cafeteria at approx 13:50 when she developed sudden difficulty walking, gait ataxia witnessed by nursing staff. States, "It felt like the floor was rolling and I couldn't stay balanced." Pt diaphoretic, hypertensive. No other focal deficits. On arrival to ED, pt continues to have gait ataxia, but no ataxia on NIHHS assessment. Denies headache. Received COVID vaccine at approx 1 pm today.
Patient reported severe itching. Red from head to toes. Said felt like tongue may have swelled a little. Took BENADRYL & doing fine. 10-20-11.
Per HCW, she developed flu-like symptoms on 3/13/21 @ 0720 am. (Approx. 17 hrs post vaccination). Other symptoms include itching to face, headache, fatigue, pain behind the eyes and sore neck muscle.  Took Motrin and Benadryl.  Per HCW, symptoms worsened. On 03/14/21 @ 03:30am she noted swollen lips, injection site swelling, fever of 102 and shivering. She denied SOB, Chest pain.  Had mild nausea and diarrhea (resolved).  On 03/15/21, Sought treatment via PCP and was prescribed Alegra 180 mg by Mouth everyday and Ibuprofen 600 mg PO every 4-6 hours.  OUTCOME: Began feeling better on 03/16/201 at approx. 1130 am.  Continues to have a "knot" at injection site.  Intermittent neck soreness and pain behind the eyes.
got the singles vaccine, got Shingles anyway/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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. 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles anyway. The patient stated that, so much for vaccines. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 13Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Type 2 DM" (unspecified if ongoing); "Recent cervical surgery 02Mar2022.", start date: 02Mar2022 (unspecified if ongoing), notes: Recent cervical surgery 02Mar2022. Concomitant medication(s) included: ATORVASTATIN, stop date: 10May2022. Past drug history included: Oxycodone, reaction(s): "known allergies: Oxycodone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of COVID-19.  Clinical course: Paxlovid was taken by the patient for which start date was 10May2022 and stop date was 15May2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shingles antival Gabapenti Still having symptoms as of 3/2/2021
This case meets criteria for vaccine breakthrough review.  Did receive booster 11/23/21 SxS include fever, dyspnea, malaise, cough, increase O2 needs.
Dec 1: developed upset stomach, by Dec 3: had chills and fever. By Dec 5, became disoriented while driving, had car wreck.
About five hours after shot chills set in, followed by fever of 100.5. Fever lasted a couple days.
6-0.5-1 mm red papules with surrounding erythema scattered in a 3 cm patch on right upper thigh;  itching.
Rash on left side of face and neck, vomiting, headache, dizziness, muscle aches, heart palpitations
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that on an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). The patient received the second dose of GARDASIL (dose, route and lot not reported) too early. The patient was not experienced any known symptoms. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information has been requested.
Covid19 breakthrough.  1st vaccine received on 03/06/2021.  72 y/o PMH ESRD on HD, LUE AVF thrombosis, Cervical CA, recurrent UTI presented to ED with c/o unresolving cough, SOB x5 days.  Room air sat 83%, CXR with infiltrates, hypotension requiring pressors and afebrile.  Admitted to ICU and treated with IV ABX, IV steroids and Remdesivir.
Patient received expired covid bivalent booster. The covid bivalent booster vial was pulled 3/1/23 and was not tossed at the end of the day. When administered, it was not caught that the vial in the box was expired. Patient was administered the vaccine.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after immunization was given during the 15 minute observation period. Emergency medical services were contacted and came to check on the patient.
APPROX. 45 MIN. AFTER I RECEIVED THE 2009 H1N1 VACCINE, I BEGAN TO FEEL THE FOLLOWING SYMPTOMS: -DIZZINESS -LIGHTHEADED -NAUSEA -SWEATING -CHILLS -WEAKNESS -PALENESS  TREATMENT RECEIVED: I WAS TRANSPORTED TO HOSPITAL AT APPROX. 1815HRS 11/21/2009. I WAS GIVEN 1 DOSE OF IBUPROFEN AND 3 LITERS OF IV FLUIDS. AFTER TREATMENT, I STILL HAD MOST OF THE SYMPTOMS LISTED ABOVE. THE MOST SIGNIFICANT SYMPTOM WAS THE DIZZINESS. HOSPITAL STAFF WAS NOT CONCERNED ABOUT ANY POSSIBLE REACTION TO THE H1N1 VACCINE, NOR DID ANY OF THE TREATMENT I WAS GIVEN HELP. I WAS RELEASED FROM THE HOSPITAL AT APPROX. 0000HRS ON 12/22/2009. MOST OF THE SYMPTOMS LISTED ABOVE WERE GONE BY 1200HRS. ON 12/22/2009. ON 11/23/2009 I WAS SEEN BY MY PRIMARY CARE PYSICIAN (PCP) FOR EVALUATION. NO MEDICINE WAS GIVEN OR PRESCRIBED. DAYS AFTER THE EVENT I STILL FELT WEAK AND TIRED WITH SOME MINOR HEADACHES.
Around the 28th or 29th of April, I started having shortness of breath and  my heart was racing. I took my blood pressure and it  was high. My pulse was 116. I went to urgent care and they checked for signs of a  heart attack or blood clot and everything came back okay,  3 days later I went to the ER at Medical Center and they took a chest x-ray and spoke with a cardiologist. Over the next month I was feeling better. Now I'm seeing a cardiologist who is going to complete a carotid artery study and at the end of the month she will try to ween me off the high blood pressure medication she will also complete blood work because she wants to check my body for inflammation  that may be caused  by the vaccine. I was prescribed Kargel 6.25 mg twice daily while at the ER which I am still taking.
This spontaneous report as received from a physician refers to a male patient of unknown age. In 2014 the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous for prophylaxis. On 17-AUG-2017 the patient experienced rash. The outcome of rash is unknown.
Pt received 4 shots in right upper arm on 4/29/15. Today arm is red and swollen and itchy. Right upper arm over deltoid has 7" x 3" area of redness, mild warmth. BENADRYL 1 tsp. po given and assessed by medical provider.
Dizziness even worse; Balance problem even worse; Normal problems seem to be intensified; Does not feel as normal; Arm was a little warm; Arm was a little red; So tired that she fell asleep for 2 hour; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness even worse), BALANCE DISORDER (Balance problem even worse), CONDITION AGGRAVATED (Normal problems seem to be intensified), MALAISE (Does not feel as normal) and FEELING HOT (Arm was a little warm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Balance difficulty. Concurrent medical conditions included Dizziness.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (Dizziness even worse), BALANCE DISORDER (Balance problem even worse), CONDITION AGGRAVATED (Normal problems seem to be intensified), MALAISE (Does not feel as normal), FEELING HOT (Arm was a little warm), ERYTHEMA (Arm was a little red) and FATIGUE (So tired that she fell asleep for 2 hour). At the time of the report, DIZZINESS (Dizziness even worse), BALANCE DISORDER (Balance problem even worse), CONDITION AGGRAVATED (Normal problems seem to be intensified), MALAISE (Does not feel as normal), FEELING HOT (Arm was a little warm), ERYTHEMA (Arm was a little red) and FATIGUE (So tired that she fell asleep for 2 hour) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable
Bells palsy-Started with L sided facial weakness on 6/14.   Parents didn't notice anything until yesterday.   When she smiles she only feels the R side moving. No pain.   Can close eyes ok but smile and raising eyebrows is off.   breathing is fine.  walking is fine.
Pain, dec rang of motion & strength in L shoulder. Significant discomfort x 10 mos. Treated with cortisone inject, anti-inflammatories, phys therapy, massage, accupuncture, chinese herbs.
12 year old child may have gotten the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child may have gotten the Moderna vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FF2589.) for COVID-19 vaccination.  No Medical History information was reported.  On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child may have gotten the Moderna vaccine). On 09-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child may have gotten the Moderna vaccine) had resolved.     it was reported that the caller was the grandfather of a 12 years old granddaughter,patient He realized the previous doses may have come from Pfizer.So they were going to check with the vaccine provider. No concomitant medications were reported.  No treatment information was provided.
Also had flu like symptoms; And / kicked his butt; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season and an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms and feels awful. On an unknown date, the outcome of the influenza-like symptoms and feels awful were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feels awful to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. In November 2019, the patient received 1st dose of Shingrix prior to the pandemic and was sore at the injection site refer case: US2021079438. He mentioned that he had received the flu short for over 65 patients within 3 to 4 weeks of the Shingrix vaccine, however, he couldn't' confirm which vaccine he received first. The patient also had flu like symptoms with the flu vaccine and both kicked his butt.  It was reported that the patient received COVID-19 vaccine recently.  The patient refused to provide any private information and did not consent to follow up. Note: As it was unclear which vaccine was received first, so as per description chronology Shingrix 1st dose was conservatively considered as concomitant products.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021079438:Same reporter.
Was fatigued and in bed Jan 17-21.  Muscle aches, chills, hot flashes, headache.  Gradual recovery.  Complete recovery 1/22/2021.  This was dose 1 of the Covid 19 series.  Patient would appreciate information on expectations for dose 2.
Swelling at injection site, erythematous rash. Received Benadryl 25 mg PO.
It was reported that a 20 year old male pt received a Menomune A/C/Y/W-135 vaccination administered on 1/16/02. Reportedly, the pt was dx'd with Bacterial Meningitis-Group C on 3/28/02. The pt is recovering. From follow-up it was reported that the patient developed onset symptoms of Meningitis on 3/27/02. From telephone correspondence received at manufacturer on 4/29/02 the lot numbers are either UB0093AA (was determined to be diluent for yellow fever as per regulatory affairs) or UB0095AA. They received Menomune, MMR Tet booster, IPV, YF and Hepatitis A. All three cases are considered recovered.
Three weeks after the 2nd dose I experienced a large red rash on my abdomen. The large rash has yet to go away. A few weeks later the rash spread to smaller rashes over the body, trunk, back upper legs, upper arms. It appears I have Pityriaisis Rosea. Some documentation on this disease states that is can be triggered by a vaccine.
Very weak and long lasting headache; Every muscle in my body ached; Very weak and long lasting headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak and long lasting headache), MYALGIA (Every muscle in my body ached) and HEADACHE (Very weak and long lasting headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Very weak and long lasting headache), MYALGIA (Every muscle in my body ached) and HEADACHE (Very weak and long lasting headache). At the time of the report, ASTHENIA (Very weak and long lasting headache), MYALGIA (Every muscle in my body ached) and HEADACHE (Very weak and long lasting headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient had these symptoms started approximately 10 hours after the shot. All night and all day today. Treatment medication was not provided by the reporter.
A dark bruise appeared at the injection site 4 months after my initial Johnson & Johnson vaccine. It was painless and healed differently than other bruises I had in the past. I was on work assignment in and seen at the clinic. I received a booster in early November. Last Thursday and Friday I was symptomatic head and body aches and mild nausea. I noticed the bruise had re-appeared and it is still there. I am currently in between health care providers and have not been seen, nor had an updated covid test. I am awaiting arrival of an at home test to check it out.
pt was given DTP/HIB/MMR/IPV 23SEP from pt's mom 24SEP stating pt had welts on arms, legs-neck & were spreading; mom brought pt in to see MD given DPH;