chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm was red; her arm was swollen; Has blisters where it is hot, red and swollen; her arm is still hot; Low grade fever; Exhaustion; Lack of appetite; acting like she has a cold; This is a spontaneous report from a contactable other hcp. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), second dose via an unspecified route of administration on 01Feb2021 16:00 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical dose included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. Patient had no reaction at all from the first dose. On an unspecified date at night patient experienced her arm was red, swollen, along with blisters where it is hot, red and swollen, arm was still hot. low grade fever, exhaustion, lack of appetite, acting like she has a cold and called because she was concerned about her reaction. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Patient called 2/3/12 has rash (L) deltoid left arm bicep anterior and axillary irregular shaped erythematous plaque of varying sizes non blanching (+) tender - no adenopathy & painful arm.
Barely able to get around, difficulty getting up from chair and toilet; Aching gout pain in muscles of hip joints and shoulders; pain in his elbows and knees; Aching gout pain in shoulders, elbows, knees. muscles in his hips; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Aching gout pain in shoulders, elbows, knees. muscles in his hips), GAIT DISTURBANCE (Barely able to get around, difficulty getting up from chair and toilet), MYALGIA (Aching gout pain in muscles of hip joints and shoulders) and ARTHRALGIA (pain in his elbows and knees) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gout and Hypertension. Concomitant products included ALLOPURINOL and INDOMETHACIN [INDOMETACIN] for Gout, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced GOUT (Aching gout pain in shoulders, elbows, knees. muscles in his hips), MYALGIA (Aching gout pain in muscles of hip joints and shoulders) and ARTHRALGIA (pain in his elbows and knees). On 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Barely able to get around, difficulty getting up from chair and toilet). At the time of the report, GOUT (Aching gout pain in shoulders, elbows, knees. muscles in his hips), GAIT DISTURBANCE (Barely able to get around, difficulty getting up from chair and toilet) and MYALGIA (Aching gout pain in muscles of hip joints and shoulders) had not resolved and ARTHRALGIA (pain in his elbows and knees) had resolved.            Patient reported that she never had aches in all those locations at once, with previous gout attacks and the symptoms lasted longer than usual as well. Concomitant medication included blood pressure medicine. Treatment details included Indomethacin for his symptoms (increased use of indomethacin).   This case was linked to MOD-2021-139294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: second dose information was added
chills, warm injection site, diarrhea, sore arm - patient is resting at home
Approx 2 minutes after receiving dose, patient became dizzy.  Per pt's father, patient became stiff and tremored some.  He lowered patient to the floor at which time there was LOC.  Reaction clinician used smelling salts which brought patient to (pt was out for approx 1 min per staff)  No loss of bowel/bladder.  Pt was brought to med obs 1 via stretcher.  Vitals taken, water and crackers given   Pt feeling well and discharged to home with father and sister Vitals:  11:46 HR 82, Resp 16, BP 109/70, O2 100 12:02 HR 86, Rep 16 BP 102/70, O2 100
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: PROBABLE VASO VAGAL REACTION-Mild, Systemic: Shakiness-Mild
Fever, chills, itchy throat, fatigue, muscle aches, cough, congestion, lost voice
16 years old female, seemed very nervouse before getting vaccine. Gave patient vaccine and she immediate closed her eyes and said she didn't feel well.  patient's eyes rolled back and patient began jerking her hands and body and seemed to pass out.  patient came to after about 5 minutes and didn't remember what had just happened. we called 911 and paramedics examined patient but parents decided to take patient home and call doctor.
DEATH; PATIENT PLACED ON VENTILATOR; COVID-19 INFECTION; ILLNESS; This spontaneous report received from a consumer concerned a 61 year old male male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was super healthy before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in AUG-2021, few days after receiving vaccine, the patient started getting sick. On 12-Aug-2021, as soon as received vaccine patient got deathly ill. On an unspecified date, patient tested positive for covid -19. It was reported that the patient was anti vaxer. On an unspecified date, the patient was hospitalized for unspecified number of days and on ventilator at time in hospital. The reporter thought that getting the vaccine and having Covid complicated patient illness. On 01-SEP-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 01-SEP-2021, and the outcome of covid-19 infection, patient placed on ventilator and illness was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20211143152-covid-19 vaccine ad26.cov2.s-Death, Patient placed on ventilator, covid-19 infection, Illness. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
COVID-19 Vaccine EUA.     Red, raised, warm, and itchy bump.  Treatment of Tylenol 1000 mg.  Applied Benadryl ointment to affected area.
The evening after receiving the vaccine, at 2130 started with chills which advanced to  sweats and chills through the night. Awoke Sunday morning with joint and body aches, headache and fatigue. Later that afternoon started with a fever- 100.3 and was not able to work the following day. Symptoms resolved in the afternoon on 1/4
Developed shingles within a 24hr of receiving MODERNA vaccine.  I have been vaccination against shingles 3 years ago, with the ZOSTAVAX vaccine. Symptoms: extreme pain, intercostal areas (under R breast-under R-arm, and R-upper back).  Saw my doctor (dermatologist) the following Monday (48 hrs post), and was given Valacyclovir, and Ultracet for pain.  Valacyclovir was given for 7 days.  Continued having extreme pain (same areas), and was given an Rx for prednisone 20mg.  Still alot of pain, continued with ice packs, OTC medications, Percocet, Ambiem (for sleep), and the Ultracet.  After 2 weeks saw my primary doctor Dr. and was told to titrate the predinisone, and begin gabapentin.  Increased gabapentin as the days continued with pain from 200mg/day, to currently 900mg/day.  Also using Lidocaine 5% patches.  Second Moderna dose was given with my doctor's approval (same location) on Friday February 5th, around 10am.  Did not notice any arm swelling, or muscle aches following vaccine, but continued with my Shingles nerve pain.  Today pain much improved, but still using Lidocaine 5% patches, and taking gabapentin.  Notified my doctor of all information.
Within 10 minutes of receiving dose patient felt  like her throat was starting to swell. Taken to hospital Emergency room at 09:59 where she received Prednisone 60mg . She watched and then discharged 10:30 with no symptoms.
Intermittent body aches and fatigue throughout the day that lasted about an hour. Tylenol taken to mitigate aches.
a bump appeared on pt's face; pt scratched the bump & it became infect c/staph infect; hosp; pt has scar on face
This case was reported by a nurse and described the occurrence of swelling arm in a child subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The nurse reported that "a number of" subjects experienced a reaction following receipt of the 4th dose of Infanrix, however , a specific number of subjects was not reported. On 01 May2006, the subject received 4th dose of Infanrix in an unspecified arm (lot AC14B021-incomplete lot number). The nurse reported that, on 02 May 2006, the subject experienced a large local reaction to the vaccination that was manifested by "swelling of the entire upper arm," injection site warmth and injection site redness. On 01May 2006, the patient also received a separate injection of inactivated poliomyelitis virus vaccine (IPOL Aventis Paateur) and MMR vaccine (manufacturer unknown). The reporter considered that the events were possibly related to the use of Infanrix. The outcome of the events was not reported.
This vaccine is approved for age 18 and older and was inadvertently administered to 12 mo old child.
Severe local reactions to right arm such as: fever, redness, pain to injection site. Severe pain in right shoulder/arm and difficulty moving arm. Started few hours after administration.
pt recvd vax;mom stated pt devel T 104.4 in eve;T dec w/ tepid baths & apap;on 1mar95 T varied from 102-103 w/ tepid baths & apap; to MD 2MAR95 & MD told mom to notify hlth dept;
patient had first dose of Pfizer around 826am and then after assessing pt around 0845 pt c/o of itchiness and scratchy throat. Notified Doctor on site re: patient's S/S. Doctor asessed and prescribed/given Benadryl 25 mg by mouth around 0850am. observed patient for 30 more mins and pt left stating feeling better. no other symptoms noted.
This case was reported in a literature article and described the occurrence of vasculitis cerebral in a 15-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified) and meningococcal acwy vaccine (non-gsk). The subject's medical history included orbital trauma. Concurrent medical conditions included exercise induced asthma. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). 10 days after vaccination with Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK), the subject experienced vasculitis cerebral (intracerebral vessel inflammation). This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was unlikely to be related to vaccination with Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK). This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Developed rash on the site of injection after 48 hours then patient to come in and purchased 1 bottle of Benadryl 25mg.
A few days after receiving the vaccines I started having seizures. These seizures have continued and are expected to continue. My neurologist is wanting surgery performed.
pt recv vax 22APR96 & 1MAY96 + vesicles over arms /abd & back;
Dizziness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 37 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Apr2021 (Lot number: EP7534, Expiration Date: 31Jul2021) at the age of 37 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication included: MULTIVITAMIN N [ASCORBIC ACID;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "Dizziness". The event "dizziness" was evaluated at the physician office visit and emergency room visit.  Additional information: Consumer have been having dizziness ever since she got the vaccine which was on 05Apr2021. She went to urgent care, to a chiropractor and to an ENT and have not taken any actual medication. She was on multivitamins.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored of RECOMBIVAX HB (lot # K010216, expiry date 17-SEP-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient stated two main adverse events. The first one is swelling in the lip and left check and the second is bone and joint aches in whole body. Patient did not report any hives or itching. Patient stated that symptoms lasted from the night after the vaccine was administered until today. The lip swelling has been slowing disappearing.
patient received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of a vial after 12 hours of initial puncture) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of a vial after 12 hours of initial puncture). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lot 047C21A Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture. One dose given 6/1/21 at time of puncture. No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-418964 (Patient Link).
I had aches and pains and I expected that but the following Monday I had a rough cough that would leave me light headache 18th of October. I didn't see a doctor on until the 23rd of Saturday. They prescribe Azithromycin 5 Day Dose Pack and a cough suppressant every 8 hours about 3x times daily for a week. I've been out of work since this last past Thursday.
Attacked all joints. Could BARELY walk, move head, use hands( started 8pm stop 9am). Excessively freezing (8pm-7am).  Fever(101.3). Nausea (8:30pm - 2am).   Diarrhea (second day - (lasted 6hrs).
10 mins in very minor soreness in arm; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA156051) via an unspecified route of administration in the left arm on 12Mar2021 at 15:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 15:15, the patient experienced 10 minutes in very minor soreness in arm. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Mar2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was unknown. The clinical outcome of the event 10 minutes in very minor soreness in arm was resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Went to urgent department on 4/5/21 with suspicion of pneumonia vs bronchitis. Given Z-pack and Augmentin. Later hospitalized 4/6-15/21 for SOB, fever s/p 1st covid vaccine. CT chest 4/6 with multifocal bilateral ground glass opacities. Acute hypoxic respiratory failure, pneumonitis (GVHD lung vs flare checkpoint inhibitor induced pneumonitis). Bronch 4/7 not infectious; TBBX no malignant cells but +eos, c/w pneumonitis. He was started on prednisone 75mg bid, central line placed and he started photophoresis. Not recommended for patient to receive further mRNA vaccines.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-FEB-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 104, 33 and R; 88, 32 and R; 208, 31 and R; 112, 30 and R; 72, 29 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
10/31/22 presents to EC ED for "shortness of breath, cough". PMHx of "COPD, HTN, GERD, T2DM, CKD"