chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative and also through a VZV identification program questionnaire refers to a 13 month old female patient. The patient did not have recent varicella zoster virus exposure or shingles. The patient had no known drug reactions or allergies. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 17-MAR-2014, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous, lot # reported J007953, expiration date 27-JUN-2015. On 19-MAR-2014, 2 days after VARIVAX (Merck) vaccination, the patient experienced diarrhea. On 20-MAR-2014, the patient experienced rash generalized on trunk and extremities, also reported as viral rash on her trunk and herpes zoster left anterior thigh at injection site also reported as a zoster like rash developed at injection site approximately the size of a half dollar coin. The physician treated the injection site as a skin infection with an unspecified antibiotic. On 20-MAR-2014, the patient's maximum temperature reported was 101 degrees. On 31-MAR-2014, 14 days after VARIVAX (Merck) vaccination, the patient experienced vesicles erythematous base. There were no laboratory diagnostics studies performed. The patient sought medical attention. Office would be submitting samples to Varicella Zoster Virus Identification Program. Physician stated that the diarrhea and viral rash cleared after fourteen days on 02-APR-2014 and 03-APR-2014 respectively. The outcome of vesicles erythematous base, diarrhea, herpes zoster left anterior thigh at injection site and rash generalized on trunk and extremities was reported as recovered. Additional information has been requested.
Pt received booster Hep A in ofc. Shortly after mom lets us know in ofc he develops rash on his stomach & legs. He is fine otherwise. Dr also examined.
Information has been received from a medical assistant concerning an unspecified patient (age and gender not provided). On an unspecified date the patient was vaccinated with GARDASIL. The medical assistant reported that GARDASIL had not been stored properly. No adverse effects were reported. Additional information is expected.
sore throat    -   sore left arm coughing (lots)   congestion    -   slight fever for 1 day  runny nose  itchy nose
got a bit of a fiber; and felt a bit sleepy; felt a little tired,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got a bit of a fiber), SOMNOLENCE (and felt a bit sleepy) and FATIGUE (felt a little tired,) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (got a bit of a fiber), SOMNOLENCE (and felt a bit sleepy) and FATIGUE (felt a little tired,). At the time of the report, VACCINATION COMPLICATION (got a bit of a fiber), SOMNOLENCE (and felt a bit sleepy) and FATIGUE (felt a little tired,) was resolving.            Concomitant medication was not reported. The patient was not tested positive or diagnosed with COVID. Patient hasn't taken other vaccine prior 1 month to Moderna COVID-19 vaccine. Patient hasn't experienced similar events in the past. It was reported that there was little improvement in the symptoms. Treatment medication was not reported.
Swollen, painful lymph nodes to left-side of neck and axilla. Painful swallowing lasted for 4 days post-vaccine.
shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-JAN-2011, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, and route not specified) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently (date unknown), the patient was treated by a physician for the following injuries resulting from ZOSTAVAX: shingles and other zoster-related injuries (ill-defined disorder). The outcome of the events was unknown. The causality between both events and ZOSTAVAX was considered to be related.
Information had been received on 01-SEP-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 20-NOV-2013 at a county health department, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, patient was treated by physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lightheadedness, slight headache and intermittent tingling to his left fingers. He reports itching to his extremities. He has not noticed a rash. He denies syncope, nausea, vomiting, sore throat, congestion, chest pain, SOB, palpitations, weakness, slurred speech, abdominal pain, diarrhea. He denies history of prior allergic reactions. No new medications. he is not anxious. Denies rash likely related to vaccine administration at 1400; seen in the urgent care at 1600 and discharged after treatment and evaluation at 1858. Inventions: ekg no acute findings; methylPrednisonolone 125 mg IV; diphenhydramine 25 mg IV; famotidine 20mg po; odansetron 4mg IV home with Benadryl 25 mg Q6 hours for 5 days.
She got her vaccine, she didn't notice anything until about an hour or so later of a severe headache.  The top of her head is where the headache was, and her eyes, had trouble with her vision focusing.  When she got home she had severe chills no matter what she did, she could not get warm.  Also her glands in her neck swelled and they are still swollen, and pressure in her ears, and aches all over as if she had the flu.  She got the flu shot last month, she did not have any reaction to that.  Last night about 4:30 she took a Tylenol quick release, and after she took that about 20 minutes or so she broke out into a sweat, and once she started sweating then the chills abated.  She still has a headache, not as bad, but
Feeling cold weak fatigue very slow gate tired sleepy beginning 5 days after vaccination with moderate improvement in next two weeks with above symptoms, but repeated drops in blood pressure starting around day 8 and persisting to present with episodes of a fib episodes 2 days later and brief leading to present prolonged episodes of  irregular beats and prolonged a fib.
she has been having continuous chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunisation series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset Oct2023, outcome "not recovered", described as "she has been having continuous chills". The event "she has been having continuous chills" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said she took the Covid-19 booster and she had continuous chills for weeks non-stop. Caller took blood tests and the results came back negative. Caller would like to know if there were also records of people experiencing that. Upon providing response, Caller stated that she got all the Pfizer COVID vaccines and all and subsequent shots and she understands that chills was part of it but never lasted for a month. Caller stated that she had taken blood test as instructed by her primary care physician and nothing showed up at all  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient has a rash on her LA after 10 days from getting her COVID-19 vaccine. It was itchy and after lots of scratching the arm became red. Patient used  HC cream, Benadryl and ointment . Better now.
muscle aches; knee pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   The patient's past medical history included knee operation.   On 31st May 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, 25 days after receiving Shingrix, the patient experienced muscle pain and knee pain. On an unknown date, the outcome of the muscle pain and knee pain were unknown.   It was unknown if the reporter considered the muscle pain and knee pain to be related to Shingrix.  Additional details were received as follows: The reporter stated that, the patient had muscle aches and knee pain, in both knees. The patient had a history of both knees having a surgical procedure but the reporter did not know what the specific procedure was. The reporter consented to follow up.
Received the vaccination.  Said immediately felt horrible pain  like pharmacist hit a brick wall.  There was bleeding which bandaid was applied to.  Had to wipe off with  tissue.  Bruising started middle of night. Swelling has occurred.  Pt has iced her arm.  Pt has continued to use the arm,  She is active with it.  Ice helps, but if take ice away pain  returns.
1100 Post vaccination reports dizziness w/no additional or associated symptoms Medical monitoring x 30  min, fluids offered, vitals assessed w/noted BP elevation 170/85 Reports "feels better" post rest and hydration , plan to f/up PMD due to elevated BP; released from facility.
About 72 hours after receiving the vaccination i was shivering uncontrollably on and off, breaking out in sweats on and off. Once i would start to feel better after sleeping 4-6 hours. I get out of bed thinking I was better, then another hour or so later the symptoms were back, so I would go back to bed shivering uncontrollably off and on again, sweating and uncomfortable until falling back to sleep.. This lasted for about 48 hours, which started 72 after receiving my vaccination.  No adverse symptoms the first 2 days following the vaccination. I got vaccinated on Tuesday, 1/19/21 - symptoms started Friday, 1/22/21 - Saturday, 1/23/21.  Sunday, 1/24/21 I finally felt normal again.
severe chest pain; scaring of heart muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: after having Covid in 2020; "myocarditis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: MYOCARDIAL FIBROSIS (hospitalization) with onset Oct2022, outcome "unknown", described as "scaring of heart muscle"; CHEST PAIN (hospitalization, medically significant) with onset Oct2022, outcome "unknown", described as "severe chest pain". The patient was hospitalized for chest pain (start date: Oct2022).  Clinical course: It was reported that patient had myocarditis after having covid in 2020 and vaccine in summer 2021, he was admitted with severe chest pain Oct2022. The reporter wanted the patient to be part of the study for any long-term risks he had scaring of heart muscle and was in hospital for week.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
w/in 5 min p/immun pt devel 1 hive or welt like lesion by rt ear; no other problems; went to MD aobut 25-30 min later & MD checked pt & gave Tavist syrup;
This spontaneous report was received from a nurse refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dosing regimen and lot # unspecified). The nurse reported that an unspecified patient developed an unspecified rash on an unspecified part of their body (unspecified date) as well as "ear pain" (unspecified ear/unspecified date) on unspecified time after receiving a dose of ZOSTAVAX. The nurse had to end the call and declined to provide any further information. No further information was provided. The outcome of both events was unknown. Causality assessment was not reported. Additional information has been requested.
Shortly after receiving vaccine, heaviness in chest. As day went on fever, chills, palpitations, stabbing pains mostly in legs. Injection site extremely painful - almost can't move arm. Note: Patient received vaccine after a fall off bicycle and had a large dirty wound.
Patient became flushed several minutes following vaccine and said she felt hot. After sitting for a few minutes it went away. Pt. left store with husband. That night felt nauseated, vomiting, diarrhea and temp of approximately 101. Was advised by RPh on duty to go to ER. Given Rx of FLAGYL. Instructed to follow up with PCP or Gastroenterologist. Stool culture was positive for C. Diff.
Patient noticed swelling on his trunk below the armpit - slightly painful - a day or 2 after receiving ZOSTAVAX.
administered an expired tenivac with no reported adverse event; Initial information received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 28 years old male patient who was administered an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7189AA) (with an unknown strength, dosage, expiry date) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Caller wants to know what to look for and if they need to revaccinate the patient.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Canker sore under tongue.  Very painful.  Have never had a canker sore previously.  Now recurrent.  No treatment.
Sore arm; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via unspecified route of administration in the left arm on 05Mar2021 at 16:30 (at the age of 47-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via unspecified route of administration in the left arm on 26Mar2021(at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient was allergic to sulfas. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) and fexofenadine hydrochloride (ALLEGRA) from unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021, the patient experienced sore arm. The patient did not receive any treatment for the event sore arm. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event sore arm was resolved o an unspecified date.   No follow-up attempts are needed. No further information is expected.
Individual was symptomatic on 12/20/21 with  cough and fatigue. Tested Covid positive on 12/21/21. Currently, in isolation until 12/30/21. Antibody testing ordered 12/22/21.
Reoccurring swelling, itching, and redness at injection site. Been ongoing since the date on injection.
Admitted to hospital 5/4/2021 with sepsis, acute hypoxic respiratory failure, Covid + fully vaccinated since mid-March, vaccine brand unknown  Still inpatient as of 5/25/2021
I have been sicker than a dog; Shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Shingles" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pneumonia shot flue; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have been sicker than a dog"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". Additional information: the patient considered the event as caused by the suspect product. The patient had a pneumonia shot flue and COVID booster shot all within the last three months and also had shingles and today and the last week, the patient was sick than a dog. The patient had no COVID but explained that the patient was still sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I just got really tired after receiving the vaccine. Late in the day on 11/07/2022 I had a sore throat. I tested positive for COVID-19 on 11/08/2022. I contacted my provider and got a prescription for Paxlovid. The taste was terrible and I vomitted once after eating some soup.  As of today, I am feeling better, but my sense of smell is little off.
Awoke with hard red knot at injection site on day 9 - pain, and itching rash
Patient had generalized tonic clonic seizure lasting approximately 3 hours: required not treatment.
pneumonia; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 12-Dec-2020.  This case involves a patient of unknown demographics who got pneumonia, after he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown), after the patient got the INFLUENZA VACCINE, the patient had pneumonia. The event was assessed as medically significant as per important medical event (IME) list.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.  There will be no information regarding the batch number for the case.; Sender's Comments: This case involves patient of unknown age who had Pneumonia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is known. Further information regarding previous vaccination, tolerance and laboratory tests ruling out alternate etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Breakthrough case admission after 3 vaccines Pfizer 1/18/21  lot# EL3249;  Pfizer 2/8/21 lot# EL9265;  Pfizer 10/14/21 lot# FF8841
Light diarrhea for 8 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Light diarrhea for 8 weeks) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 006B21A) for COVID-19 vaccination.     Concomitant products included MELATONIN for Sleep disorder therapy, COLECALCIFEROL (VITAMIN D3) for Vitamin D supplementation.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIARRHOEA (Light diarrhea for 8 weeks). At the time of the report, DIARRHOEA (Light diarrhea for 8 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: inconclusive Inconclusive. On an unknown date, X-ray: inconclusive Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided.    This case was linked to MOD-2021-194982 (Patient Link).
Muscle aches, headache, chills lasting from the morning of 7/20/2021 to morning of 7/21/2021.  I took Tylenol for pain, which seemed to help.  Slept at least 10 hours on the night of 7/20-7/21.  Feeling a little better the morning of 7/21.
Morning after vaccination, around 7am awoke feeling slightly unwell, worsened through the morning to slight fever, headache, nausea, chills, genera debilitating discomfort; began abating 8-10pm and returned to comfortable condition around midnight
Site: Pain at Injection Site-Severe, Systemic: pain in the arm lasting for several pain   patient tried aspercream sleep and various pain med   helps minor with the symptoms but pain is not going away-Severe, Systemic: Tinnitus-Mild
Nausea, diarrhea 2 hours after administration of vaccine. Tiredness, chills, nausea and diarrhea for 48 to 72 hours.
Edema (L) arm. Pt c/o soreness (L) arm presently.