chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Haemophilus influenzae type b (HIB) infection; Virus infection; This case was reported in a literature article and described the occurrence of hemophilus influenza infection in a child patient who received Haemophilus influenzae type b vaccine for prophylaxis.  On an unknown date, the patient received the 1st dose of Haemophilus influenzae type b vaccine. On an unknown date, unknown after receiving Haemophilus influenzae type b vaccine, the patient experienced hemophilus influenza infection (serious criteria hospitalization and GSK medically significant) and viral infection. On an unknown date, the outcome of the hemophilus influenza infection and viral infection were unknown.   The reporter considered the hemophilus influenza infection to be related to Haemophilus influenzae type b vaccine. It was unknown if the reporter considered the viral infection to be related to Haemophilus influenzae type b vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Haemophilus influenzae type B (HIB) infection in a child aged less than 5 years of unspecified gender, who was vaccinated with unspecified Haemophilus influenzae type b (HIB) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of retrospective study that aimed to describe the cases of all hospitalized patients with culture-proven invasive Haemophilus influenzae infections at Hospital, between 2009 and 2018. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received only 1 dose of unspecified Haemophilus influenzae type b (HIB) vaccine (administration route and site unspecified, batch number not provided). The age of vaccination was not provided. On an unspecified date between 2009 and 2018, an unknown period after the vaccination, the patient's blood culture or cerebrospinal fluid (CSF) culture or both blood and CSF culture showed Haemophilus influenzae type B (HIB). Subsequently, the patient was hospitalised and diagnosed with culture-proven invasive Haemophilus influenzae type B infection at Hospital. The patient had virus coinfection.  This case has been considered as serious due to hospitalization. Treatment was unknown. The outcome of the event was not reported. The author did not comment on the relationship between the event of Haemophilus influenzae type B (HIB) infection and unspecified Haemophilus influenzae type b (HIB) vaccine. The authors concluded, "Invasive H. influenzae infections were associated with substantial morbidity and a 2% case-fatality rate." This article corresponding to this case is not available for regulatory submission due to copyright restriction.      Lab Comments: On an unspecified date between 2009 and 2018, the patient's blood culture or cerebrospinal fluid (CSF) culture or both blood and CSF culture showed Haemophilus influenzae type B (HIB).
I had extreme dizziness, vertigo, and my sinuses were really dry. I felt like I had a stuffy head. I went to my local ER on December 31, 2021. I was vomiting because of the dizziness. It felt like my ears were plugged. I do have a history of sinus stuff, but I never had a dryness with it before. The doctor had prescribed me with Ondansetron and Meclizine. I continued to have that dizziness for three days. I had continued issues with dryness in my sinuses as well. January 13, 2022 I saw another doctor who prescribed me with Prednisone. Then she prescribed Doxycycline.  I'm still not feeling up to par.
pt recvd vax;devel swelling on rt side,which resulted in difficulty talking;took a Xanax just p/tongue swelling began;p/ tx w/ IM dph & ice chips,condition improved;later worse,pt tx w/decadron,dph;BP=158/96;P=72;color good;
LEFT ARM/SHOULDER PAIN AND STIFFNESS WITH GENERALIZED JOINT PAIN AND BODY ACHES STARTED SAME DAY AS VACCINE
This spontaneous report received from a pharmacist concerned a 6 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: 27-APR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced received a Janssen Covid-19 vaccine that the temperature of the fridge had gone up to 46.9 F for 17 minutes, and out of specification product use. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a Janssen Covid-19 vaccine that the temperature of the fridge had gone up to 46.9 F for 17 minutes and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121692.
A physician reports post vaccine, that evening pt developed fever of 102F, 24 hours post vaccine he developed generalized hives.
Syncopal episode during 15 minute waiting period. Was sitting in a chair and was syncopal and fell out of chair onto the floor. Woke up immediately. Monitoring period extended. Recovered and went home.
Almost immediate left shoulder tingle.  Tingle progressed up to shoulder, collarbone area, left side of neck, underside of chin.  Some numbness accompanied the tingling.  Left cheek and left ear felt hot (internally).  These symptoms never worsened.  Subsided approximately 2-3 hours after vaccination.  About 6 hours later, my left calf was incredibly itchy.  I took a Benadryl and went to bed.  Felt normal the next day.
Muscle aches; chills; nausea; vomiting; diarrhea; sweating; fever to 101.2; headache; This is a spontaneous report from a contactable nurse (patient). This 37-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK4176), via an unspecified route of administration on 09Jan2021 15:15 at single dose on the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. No other medications received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number: EK5730) on 20Dec2020 15:15 at single dose on the left arm for COVID-19 immunization. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced muscle aches, chills, nausea, vomiting, diarrhea, sweating, fever to 101.2, headache on 10Jan2021 02:00. No treatment received. Outcome of the events was recovering.
Two  tonic-clonic seizures just hours before receiving second dose of the vaccine, exactly 21 days after the first dose.   development of epilepsy, no previous history of seizures.
Low grade fever, body aches, and generalized body weakness which started approximately 24 hours after getting the dose that lasted until the following day (duration of symptoms lasted about  24 hours ).  Symptoms resolved about 24 hours without treatment - just hydration, rest, and sleep.
Rash/welt on shot arm developed 2 days later underneath arm not at injection site. Red blotchy not itchy but very tender and bruised feeling.
Fever of 102, severe headache that wouldn't go away with ADVIL, severe total body aches and pains, weakness, nausea. I couldn't even walk. Stayed in bed, but difficult to get comfortable, body pain. The second day I feel better, but still have the headache, and feel slightly out of it.
Initial report received from a consumer on 21 May 2012. Local reference number: 12-0296. A 52 years female patient, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL on an unspecified date (lot number: C4030AA) on left deltoid on 09 May 2012. It was reported that on 14 May 2012 the patient experienced general malaise, periorbital edema, achyness 5 days post vaccination and sore throat 12 days post vaccination. The patient was evaluated by the physician from 14 May 2012 and 21 May 2012. No treatment was prescribed. The outcome of the adverse reaction was not reported. List of documents held by sender: none.
screaming; crying for 5 hrs; t100 states MD doesn't want pt to have any more pertussis;
Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 80-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no pre-existing condition. Concomitant product use was not provided by the reporter. It was reported that expired vaccine was administered to the patient as first booster day after it's expiration. Treatment information was not provided.
cold; arm was sore; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (cold), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (arm was sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027620A and 026620A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and INJECTION SITE PAIN (arm was sore). At the time of the report, NASOPHARYNGITIS (cold), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (arm was sore) outcome was unknown.            No relevant concomitant medications reported.  Patient's health care provider approved the use of aspirin to help with the side effects.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
pt recv vax & 5-10min p/vax pt fell while walking & was pale, limp & unconscious;breathing ceased for approx 2-3 seconds;incident lasted approx 15-30seconds;pt became alert on own & was taken to clinic for eval
Information has been received from a registered nurse (R.N) concerning a patient who on 11-JUN-2008 was inadvertently vaccinated with a dose of VARIVAX (Merck). No symptoms were reported. A product quality complaint was not involved. Additional information has been requested.
pt developed large swollen area at injection site. Was seen by Dr. and was given Cephalexin 500 1 PO TID x 7days due to MD believing it was a bacterial infection caused by vaccine
Painful Swollen lymph node under left armpit, fatigue,  starting few hours after injection
Right after MMR vaccine being given pt started scratching at injection site. Site welted up and became very red. Dr. came and accessed pt approx 2 minutes after vaccine was given and pt seemed well. Dr advised to Mom to wait to make sure reaction had stopped and Mom chose to leave AMA.
Urticaria within 5 minutes of immunization. Bilateral thighs with associated edema, redness, swelling. BENADRYL 12.5 mg IM given with resolution. *At MMR and Varicella sites*
Increased swelling at site of DTaP injection--TO. MD on 9/6 states that worse reaction I've seen in a long time. Edema shoulder to hand, area red and warm to touch. Complained of pain in arm.
Ear cartilage got bright red, itchy neck and face, questionable fine rash. Several patches left volnar forearm; no urticaria. Afebrile, no erythema, no adenopathy.
This spontaneous case reported by a consumer, describes the occurrence of administered expired product (received dose post-punctured for over 12 hours) and product storage error (dose punctured for over 12 hours) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (received dose post-punctured for over 12 hours) and product storage error (dose post-punctured for over 12 hours). At the time of the report, administered expired product (received dose post punctured for over 12 hours) and product storage error (dose punctured for over 12 hours) outcome: unknown.  No concomitant medication or treatment information provided.
This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargic), FEELING ABNORMAL (Punky), HYPERSOMNIA (Slept a lot) and FATIGUE (Tired) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced LETHARGY (Lethargic), FEELING ABNORMAL (Punky), HYPERSOMNIA (Slept a lot) and FATIGUE (Tired). On 06-Jun-2021, LETHARGY (Lethargic), FEELING ABNORMAL (Punky), HYPERSOMNIA (Slept a lot) and FATIGUE (Tired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. It was reported that the patient felt nothing with the first shot. This case was linked to MOD-2022-457985 (Patient Link).
A male patient approximately 70 years old, has been receiving Tice BCG for treatment of T1 Bladder Cancer.  In February 2003, a second maintenance series of 3 instillations was given.  Very shortly after the third instillation the patient began to experience "very severe arthralgias", which still persisted through the time of this report.
Pt. had no record of prior vaccination with covid Vx and was aware he was receiving Dose 1 of Moderna primary series and signed consent form. After receiving vaccine he asked how he could find out where he received other shots?  Thought he went to a clinic or pharmacy.  Told him to check with them and he left.  Then checked vaccine registry and found he had already received Pfizer primary series and booster.  Should have received Moderna Bivalent booster today.
Serious hives over 25% of body lasting for 6 days, took Benadryl every day and they went away but came back in 24 hrs. I have never had hives before.
Within about 2 weeks of shot, patient reports that symptoms of aches/pain in shoulders and neck, upper arms, hips, buttocks, thighs, stiffness, limited range of motion, fatigue, malaise, depression, began and steadily worsened. First reported this to us on 7/26/13.
Per patient, patient experienced soreness, itching, cramps in finger, and swelling from injection site. Injection site was warm to touch but patient does not have any fever. As of 03/13/19, patient's symptoms had be reduced. Pain had been reduced, swelling had been reduced, itching had been reduced.
Within 4 days after admin immun PO pt had emesis with increased temp 99.4
Vaccine used was FLUARIX QUADRIVLAENT (GSK) Patient voluntarily received annual flu vaccine as part of our company annual free flu vaccine campaign where our employees are offered the vaccine free of charge. Patient received the vaccine from our pharmacist on duty with no problem or complaint. He returned to his work station where he stands and enters orders in the computer (he's a pharmacy technician). About 5 min later, he passed out and his head hit the counter that was behind him. He remained passed out for about 10-15 seconds. Assistance was provided by myself (I am also a pharmacist) and our staff pharmacist. 911 was called as a small wound was present on his occipital region due to contacting the countertop on his way down, and to provide further medical evaluation. He was evaluated at the ED. All imaging was negative and the small laceration was repaired. The attending provider concluded that a vagal response to the injection was likely responsible for the post-vaccination syncopal event. This patient has received flu vaccines for the past 3 plus years without any reaction of this sort.
Patient was given Moderna for dose #2 when Pfizer was given for the first dose. Patient was monitored in office for 30 minutes and no reaction was noted. Patient was aware of mixed dosing following injection.
Pain, redness and swelling at injection site increasing daily for at least 4 days now.  Swelling is a lump approx. 2 inches that is painful and throbbing without stimulation.  Surrounding is a 2? X 4? vertical  strip of deltoid that is painful, light red, and hot to the touch.
Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (exposed to 33F for 0.5 hours) ROTATEQ (lot # K010224, expiration date 13-MAY-2016, dose was unknown, orally) (Incorrect product storage). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left injection site arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left injection site arm). At the time of the report, PAIN IN EXTREMITY (Sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-404528, MOD-2021-404541.
Patient woke up at 3:00 AM freezing and sweating with a bad headache. Chills and sweating stopped by 7:00 AM but slept for a majority of the day due to headache persisting.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 11-year-old male patient who received MENVEO for prophylaxis. On 4th August 2018, the patient received the 1st dose of MENVEO. On 4th August 2018, unknown after receiving MENVEO, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 5th August 2018, the patient experienced swelling arm, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the swelling arm, erythema of extremities and itchy upper limbs were recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities and itchy upper limbs to be related to MENVEO. Additional details were provided as follows: This case was reported by the patient's mother. The patient received only the liquid component of MENVEO to left arm. The liquid Men CYW-135 liquid component was not reconstituted with the lyophilized Men A component before administration, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The next day after receiving MENVEO, the patient experienced redness, swelling and itching on his left arm. The reporter stated that the patient's left arm was swollen and the bright redness was approximately 4 inches across his arm. The reporter stated that she called the patient's doctor to report this, however, the patient was not seen at the doctor's office.
pericarditis; A fibrillation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2016-020714 (RA).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA) (Batch/Lot number: unknown) at 20 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for covid-19 immunisation. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A fibrillation". The action taken for lenvatinib mesilate was unknown.  Clinical course: Patient mentioned that his thyroglobulin increased after missing 2 doses of Lenvima. He also said that in 2018 he was on Lenvima and had to decrease the dose due to bad side effects.  Pfizer is a marketing authorization holder of bnt162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of bnt162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child had prickly rash on arm area on 8/12/02. On 8/15/02 he had raised red area that grew together then on both legs-area were hot mom said. The swelling was halfway between top and thigh to knee and went around halfway around leg. She took baby to Dr on 8/15/02. No meds given. By 8/17/02 the swelling was gone. No fever.
moving like an old person now; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (moving like an old person now) and MYALGIA (muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included DVT, Chronic pain and Spinal cord neoplasm (sand spinal cancer). Concurrent medical conditions included Atrial fibrillation. Concomitant products included AMIODARONE, GABAPENTIN, METOPROLOL TARTRATE (METOPROLIN), RIVAROXABAN (XARELTO), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and CANNABIDIOL (CBD OIL) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (moving like an old person now) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (moving like an old person now) and MYALGIA (muscle pain) outcome was unknown.            The patient lab test includes EKG, blood work, and chest x-ray.   This case was linked to MOD-2021-194873, MOD-2021-194873 (Patient Link).   Reporter did not allow further contact