chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHINGLES  delayed symptoms onset est 4-5 days after Second Pfizer Booster jab.First experierenved burning pain like a sunburn on back of neck and a subsequent raised welt. Then progressed  and scattered down neck on to  same side ushoulder,back and chest. Has now mostly  now fully blistered out and scabbing over breakage. Been suffering with the sharp intense pain for approx 4-5 days since initial burning symptom.
7 case pairs (more than one person in household) of tinnitus; 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 TINNITUS (7 case pairs (more than one person in household) of tinnitus) 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 TINNITUS (7 case pairs (more than one person in household) of tinnitus). At the time of the report, TINNITUS (7 case pairs (more than one person in household) of tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: ADR form received- No new information
Initial report was received from a consumer, who was also the patient's parent, on 14 May 2012. A 17-year-old male patient, with no reported medical history, had received an injection of MENACTRA, sanofi pasteur Inc. (lot number, route and site not reported) on 11 April 2012. Two weeks after vaccination, the patient started to experience headaches, then about one and a half weeks ago started to experience pain behind eyes which continued on the day of the report. The pain seemed to be getting worse and was so bad he couldn't wear his contact lenses. The patient saw an ophthalmologist but the cause of eye pain was not determined. Blood work was done (details not reported) and an MRI was scheduled. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Pain in the injection site; difficulty to sleep due to that pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and difficulty sleeping. On an unknown date, the outcome of the injection site pain and difficulty sleeping were unknown.   It was unknown if the reporter considered the injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but the patient was over 65 years old. The reporter did not provide initials, date of birth of the patient nor lot number and expiration date of the vaccine administered. It was reported that the patient received the first dose of Shingrix and started to experience pain in the injection site and difficulty to sleep due to that pain.  The reporter did not consent to follow-up.  The reporter mentioned that the patient received the vaccine sometime during the 2 last weeks of March 2020 in a pharmacy.
The pt was seen on 3/5 for left hand laceration. A TD was given in the right deltoid. The pt returned on 3/7 complaining of pain and redness at the injection site. Diagnosed with cellulitis to right shoulder area.
Patient came in today on 11/15 and told me about her symptoms she had when she got her flu shot on 11/1. She experienced redness, swelling, pain at injection site and later had flu-like symptoms of fever, congestion, nausea and fatigue which she said lasted 5 days. No treatment from Dr was sought out.
Woke up the next morning and all her joints on the right side was hurt. Took Tylenol and it clam it down. Talk to Doctor about it.
Tonic seizure with loss of consciousness lasting 90 seconds in clinic followed by 60 minute post-ictal state.  Patient received Anthrax vaccine #1 at 2112 on 4/18 and had event within clinic at 2116 of same evening (4/18).  Patient struck head on floor when seizure began.  He was stable and alert at the time of transfer to the Hospital.  Patient presently hospitalized with normal head CT and electrolytes.  Urine testing during hospitalization suggestive of presence of barbiturates in urine although patient reports taking no medications.  Over two hundred vaccines from the same lot were administered within 24 hours of the event in various clinics with no other similar events.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of increased crying in an unknown number of child subjects of unspecified gender who were vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer given on an unspecified date. On an unspecified date the subjects received unspecified dose of ENGERIX B (details unknown), which had not been shaken prior to administration (inappropriate preparation of medication). At an unspecified time after vaccination with ENGERIX B, the subjects experienced increased crying. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that they had not been shaking ENGERIX B prior to administration and had noticed that this seemed to result in "more crying" after administration to a number (unspecified) of pediatric subjects.
Sinuses were running after 1st shot; Throat was burning after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Allergy (Another Doctor (ENT-2) did allergy test in MAY2021 and She has a history of allergies.).    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot). At the time of the report, SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) to be possibly related.    Concomitant medication was not provided.  The patient received the first dose of Moderna COVID-19 vaccine on 11Jul2021 (Lot# 048C21A & Exp. Date: unknown) in her right arm. Two weeks later, her sinuses were running and her throat was burning. She visited a doctor, but they did not do any COVID test.  Company Comment: This case concerns an 83-year-old, female patient with a medical history of Gastroesophageal reflux disease (GERD), who experienced the unexpected non-serious events of sinusitis and throat irritation. The events occurred 2 weeks after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was positive as the events recurred after admininstration of the second dose of the Moderna COVID-19 Vaccine. The medical history of GERD, which may cause throat irritation, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-335341 (Patient Link).; Sender's Comments: This case concerns an 83-year-old, female patient with a medical history of Gastroesophageal reflux disease (GERD), who experienced the unexpected non-serious events of sinusitis and throat irritation. The events occurred 2 weeks after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was positive as the events recurred after admininstration of the second dose of the Moderna COVID-19 Vaccine. The medical history of GERD, which may cause throat irritation, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
his platelets dropped to 9k (9000) and went to the emergency room./He is having life threatening low platelets; This is a spontaneous report from a contactable physician. A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 27Mar2021 (Age of vaccination: Unknown) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number/Expiration date: Unknown) on 05Mar2021 for covid-19 immunization. On 17Apr2021 the patient experienced his platelets dropped to 9k (9000) and went to the emergency room and he is having life threatening low platelets. The patient underwent lab tests and procedures which included platelet count: 9000 on 17Apr2021, his platelets dropped to 9k (9000) , platelet count: 200000 on 2021 this helped bring his platelets up to 200 (k) , platelet count: 400000 on 2021 they (the platelets) went up to 400 , platelet count: 1000 on 2021 platelets dropped down to 1000 , platelet count: 25000 on 2021 Last week it was 25k. Therapeutic measures were taken as dexamethasone 40mg for 4 days and Promacta as a result of his platelets dropped to 9k (9000) and went to the emergency room and he is having life threatening low platelets. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event platelet count decreased cannot be totally excluded.   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.
Information has been received from a 50 year old male registered nurse, who in 10/04, was vaccinated with the first dose of Pneumococcal 23v polysaccharide vaccine. Twenty four hours after the injection, he developed flu like symptoms, soreness and a fever. The nurse reported that the fever lasted about a day. The nurse did not seek medical attention. At the time of this report, the nurse had recovered from the events. Additional information has been requested.
10/29/2003: Patient received Pneumovax to right deltoid at work.  That afternoon patient had sigificant swelling (entire upper arm), pain, redness, chilling, fevers, nausea.  We examined patient on 10/30/2003.
Patient is a 81-year-old woman who last Tuesday received her second vaccination shot in her left arm.  Several hours after the procedure she developed pain and discomfort in her left arm.  The left arm discomfort gradually increased over the past 3 to 4 days and she began to experience symptoms of claudication in her left forearm and hand.  She had a difficult time performing her daily tasks.  The pain significantly worsened today to the point that she had constant pain in her hand and developed numbness in her fingers.  She presented to the urgent care clinic and was subsequently transferred to the emergency room where CT angiogram demonstrates thrombus in her left brachial artery.  She denies a history of heart palpitations.  She has no history of hypercoagulable state.  She has no history of blood clots or easy bleeding.  She has no history of infection and denies fevers chills or night sweats.  She has no significant history of peripheral vascular disease and can walk over a mile without difficulty.  She denies symptoms of transient ischemic attacks.  Left brachial ulnar and radial artery thrombectomy due to inflammation of the brachial artery and thrombus in the brachial artery extending into the origin of the radial and ulnar arteries done on 3/22/2021. Discharged on aspirin 81 mg daily and Lovenox. Has transitioned to Eliquis now. Complication of left arm wound dehiscence. Debrided by wound clinic on 4/9/2021. Taken for washout/wound closure on 4/13/2021. Continues to f/u in our clinic.
horrible aches; flu like symptoms; could not get out of bed; fever; lymph nodes swelled under her arms to the size of lemons; lymph nodes are sore; congestion; intermittent smelling of cigarette smoke; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (horrible aches), PAROSMIA (intermittent smelling of cigarette smoke), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and NASAL CONGESTION (congestion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAROSMIA (intermittent smelling of cigarette smoke), NASAL CONGESTION (congestion), LYMPHADENOPATHY (lymph nodes swelled under her arms to the size of lemons) and LYMPH NODE PAIN (lymph nodes are sore). On 18-Feb-2021, the patient experienced PAIN (horrible aches), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and PYREXIA (fever). The patient was treated with FLUTICASONE at an unspecified dose and frequency. In February 2021, PAIN (horrible aches), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and PYREXIA (fever) had resolved. At the time of the report, PAROSMIA (intermittent smelling of cigarette smoke), NASAL CONGESTION (congestion), LYMPHADENOPATHY (lymph nodes swelled under her arms to the size of lemons) and LYMPH NODE PAIN (lymph nodes are sore) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications reported.
Patient complained of difficulty taking a breath approximately 15 minutes after vaccine administered.   Mother reported that this happened after his first Pfizer dose. At that time symptoms only lasted 10 minutes.  Patient observed. Stated that symptoms seemed like they were improving some. Patient was instructed to take deep breaths and was continually observed. Respiration rate at that time 22. Total observation period approximately 1 hour, symptoms stayed the same. No angioedema, abdominal pain, nausea, vomiting, chest pain.    Patient did not appear tachypneic.  Patient appeared non-distressed. Able to speak in full sentences. Skin color normal. No audible wheezing. No rashes/hives. Vital signs were taken about 30 minutes after vaccine administered and repeated about 15 minutes later. Vitals: pulse ox 96%, BP 128/73 mmHg, RR 22, Pulse 79, Temp 97.2 degrees F.  Based on patient appearance and vitals, on-site emergency protocols did not need to be deployed.   Patient instructed to call PCP to be evaluated, or go to ED if symptoms worsen.   Patient's mother spoke to PCP on the phone. Patient was instructed by PCP to be evaluated in emergency room. Patient's father came to school. Patient's parents left and took him to emergency room approximately 1.5 hours after vaccine administration.
This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
The pt complained of severe headache and vomited four times approx. 3hrs after initial injection was given.
LOST CONSCIOUSNESS; RHABDOMYOLISIS; TRAUMATIC FALL; PULMONARY EMBOLISM; ACUTE KIDNEY INJURY; DEEP VEIN THROMBOSIS IN RIGHT LOWER LEG; This spontaneous report received from a physician concerned a 38-year-old Male, race and ethnicity unknown. The patient's weight was 96 kilograms, and height was 183 centimeters. The patient's past medical history included panic attacks, prehypertension, syphilis, oropharyngeal gonorrhea, mild gynecomastia, and amphetamine use disorder. The patient was not on any medication at the time of event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 10-Apr-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-Jul-2021, the patient lost consciousness at home and was transported by ambulance to the local emergency Room. The patient was hospitalized on an unspecified date. The patient was found to have deep vein thrombosis in right lower leg and extensive pulmonary emboli. The reporter stated that no predisposing factors developed DVT (deep vein thrombosis) such as long time in stationary position or trauma to leg. The Patient was taken to the operating room for embolectomy and was started on anticoagulants. The patient experienced rhabdomyolysis due to traumatic fall and acute kidney injury during hospitalization. On 16-Jul-2021, the patient was discharged from hospital, with oral anticoagulant therapy (Apixaban 5 mg).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, acute kidney injury, and rhabdomyolisis, and the outcome of deep vein thrombosis in right lower leg, lost consciousness and traumatic fall was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20210820514.; Sender's Comments: V0: 20210835633-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pulmonary embolism, Acute kidney injury, Deep vein thrombosis, Lost consciousness, Rhabdomyolysis, Traumatic fall. This event(s) is considered unassessable. The event(s) 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(s).
Right deltoid post injection bruising (healing) TDAP on 9/21/16 visit for S/S 9/29/16. No angioedema, respiratory distress or other noted immunological S/S. No problem with past vaccine.
Lumps popped up on right side of breast; Soreness in the arm; Caller states what's going on with her is she is having come concerns about the first dose; Bumps in her armpit; And she thinks they're swollen lymph nodes.; This is a spontaneous report from Pfizer Sponsored Program. A female consumer (patient) reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified date two weeks after patient received her first one, the patient started having soreness in the arm, also stated then she had bumps in her armpit, lumps popped up on right side of breast and she thinks they are swollen lymph nodes, they are closer to the breast .The patient does have an appointment for the lumps to be looked at on her breast.She had some concerns about the first dose, said lumps popped up, not sure they are related to the Pfizer vaccine. The patient stated that she has lumps on the side of her right breast, and she does not know if that was due to coronavirus.The patient wanted to get some clarity before her appointment tomorrow for Pfizer and wanted to know if she should get the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
1 of 5 pts who were vaxed from the same lot# & exp an adverse event;pt recvd vax 8JUN95 9PM;the following morning pt was unresponsive x5mins;had drop in BP to 70/40 & shaking more than usual;
Dizziness, Headache, Myalgia, Fever, SkinRash, NauseaVomiting,  Fatigue, Loss of taste, Chills, Difficulty moving left arm, Unsteadiness, Nasal congestion, Scratchy throat Narrative: Self medicated with benadryl and tylenol as needed.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Hypertension-Mild
Narrative:  Patient had a PMH of type 2 diabetes mellitus, hyperlipidemia, PTSD, tremor, COPD/coal workers pneumoconiosis, hypertension, hip/joint pain, and obesity Patient received both the Moderna COVID booster and the Quadrivalent preservative free (Afluria) influenza vaccine on 11/4/21 Received 1st dose of Moderna COVID Vaccine on 2/13/21, 2nd dose on 3/13/21, 3rd (booster) dose on 11/4/21, Primary care nurse contacted patient's residence 11/5/21 to discuss knee x-ray findings. Patient's wife informed nurse that patient had passed away the night before on 11/4/21. Cause of death or other information currently not available at time of this report.
positive for COVID; positive for COVID; This is a spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 2nd of 3 reports. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 20Jan2021 (Batch/Lot Number: EL3302) as SINGLE DOSE for an unspecified indication. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced positive for covid (drug ineffective) (non-serious) on 04Feb2021 and positive for covid (sars-cov-2 test positive) (non-serious) on 04Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Feb2021. The outcome of the events were reported as not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162208 same drug and event, different patients;US-PFIZER INC-2021162159 same drug and event, different patients