chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 20 year old female pt received Menomune , lot UA298AA, administered SC in the rigth arm at 9:30am on 2/26/01. The pt developed meningococcemia secondary to Group C N. meningitis, on 10/20/03. The pt was hospitalized and still remains in the ICU. She has not recovered from these events. No other info was reported. From additional information obtained on 11/3/03 from a telephone contact with the reporting physician, it was reported that the physician spoke with the patient's father who reported that the patient was still in the intensive care unit and was intubated and in renal failure. Additionally, the patient may lose her fingertips due to the vasopressive therapy she is undergoing. From additional information received on 11/6/03 from the responsible physician, it was reported that the patient also received a Mantoux tuberculin skin test (lot number and manufacturer not reported) on 2/26/01 at the same doctor's visit. No other information was provided at this time.
At 4:45pm on March 14, 8days after receiving first dose, I noticed a red bump on my left arm (arm where the vaccine was injected). It was tender and warm to touch with something solid being felt under the surface. Around 9:30pm, the same bump became itchy.
Patient was given flublok on 9/10 and given fluzone high dose on 10/5 with no A/E; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received via an other health professional (under reference number: US-SA-SAC20211008000035).  This case involves an adult patient with an unknown age and gender who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on 9/10 INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 10/5 with no adverse event (extra dose administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On 10-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On 05-Oct-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (after 25 days) lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Clinic manager called me to find out next steps."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  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.  There will be no information on lot number for this case.
expired dose of Typhim VI was given to a patient (with no reported adverse event); Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 22-years-old female patient (Not pregnant) who was administered expired dose of typhoid VI polysaccharide vaccine [Typhim VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Yellow Fever Vaccine, and Rabies Vaccine for Prophylactic vaccination.  On 06-Nov-2023, the patient received 0.5 mL expired dose of suspect typhoid VI polysaccharide vaccine (Frequency: once; Strength: Standard) (lot number: U2A471M; expiry date: 02-Nov-2023) via intramuscular route in the left deltoid as Immunization for Travel (Immunization) with no reported adverse event (expired product administered) following the administration of typhoid VI polysaccharide vaccine.  Treatment: No  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.
In this order coming to full reaction by 12/20/2013. Deep strong sneezing, tickle in sinus/upper throat area, shortness of breath, difficulty breathing even to eat, fatgue,- started nebulizer treatments 1212/21/2013, large hives on the upper torso, burning/pain in sinus/upper throat area, slight fever ranging from 100/101 degrees, out of it unable to stay away, received double shot for allergic reations, antihistimines Pepcid, updraft medication-Xopenex, cromyline solution.
Itching expanded to the whole body; Itching that started at the upper left arm; Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching expanded to the whole body), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and VACCINATION SITE PRURITUS (Itching that started at the upper left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Usually use a inhalator for asthma.).    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021 at 10:00 PM, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). 29-Oct-2021 at 10:00 PM, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (Itching expanded to the whole body) and VACCINATION SITE PRURITUS (Itching that started at the upper left arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Oct-2021 at 10:00 AM, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, PRURITUS (Itching expanded to the whole body) and VACCINATION SITE PRURITUS (Itching that started at the upper left arm) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Developed a bilateral lower extremity peripheral neuropathy several weeks after vaccination. Confirmed by recent EMG/NCS.
Woke up Saturday morning three days after 1st Pfizer vaccine on Feb 20, 20201 at 5:25 a.m. and I was extremely dizzy.  stayed in bed and slept until about 5:00 p.m. and got up at 7:15 p.m. for about 15 minutes then went back to bed until Sunday morning around 6;10 a.m. and felt fine.
Four months since first dose; 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 PRODUCT DOSE OMISSION ISSUE (Four months since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Four months since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Four months since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO CONCOMITANT AND TREATMENT DRUG WERE USED
Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms started 5-10 minutes after patient received her 2nd Pfizer vaccine dose. Patient has h/o vertigo and reported vertigo, headache, nausea, and emesis following the first vaccine dose. Unsure if syncope 2/2 vaccine vs vaccine adminitration anxiety vs h/o vertigo. NS bolus, Benadryl, Ativan, Tylenol, and Motrin were given. Normal EKG. Symptoms improved and patient discharged from the ED.
Feeling terrible, awful feeling; pain; arm hurts; chest pain; weakness; Exhaustion, chest muscle tired when talking; Throbbing headache; fever; chills; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling terrible, awful feeling), PAIN (pain), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (chest pain) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling terrible, awful feeling), PAIN (pain), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (chest pain), ASTHENIA (weakness), FATIGUE (Exhaustion, chest muscle tired when talking), HEADACHE (Throbbing headache), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling terrible, awful feeling), PAIN (pain), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (chest pain), ASTHENIA (weakness), FATIGUE (Exhaustion, chest muscle tired when talking), HEADACHE (Throbbing headache), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown.            This case was linked to MOD-2021-090528 (Patient Link).
doesn't think she got the full dose either time; underdosed; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (doesn't think she got the full dose either time) and UNDERDOSE (underdosed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (doesn't think she got the full dose either time) and UNDERDOSE (underdosed). On 27-Mar-2021, INCORRECT DOSE ADMINISTERED (doesn't think she got the full dose either time) and UNDERDOSE (underdosed) had resolved. Not Provided          Patient reported that she received both the doses of Moderna vaccine but was under dose both the time, She wanted to know if she can get vaccinate again with full dose.  Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   This case was linked to MOD-2021-090489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-JUN-2021 contains significant information: Added New Event  (Underdose) On 28-Jun-2021: Non-Significant Follow up Appended - Reporter mail address updated
Headaches, fevers of up to 102, nausea, chills, body aches, fatigue, palpitations upon standing with dizziness, feeling faint and nausea.  Last fever episode was Monday night. Body aches, palpitations, nausea, dizziness and feeling faint were persistent until yesterday evening.  Still having mid headaches and fatigue.
Full body hives that started on neck and have spread through arms, legs, etc. Very itchy, burning and swollen. Over the counter antihistamines and Benadryl not working. Started on steroids today but no relied so far. Going to the doctor tomorrow.
Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm.   At 2:am  next morning, March 17, sudden severe nausea and diarrhea, severe headache, hot flashes and sweats continued for 2 hours.  Intermittent syncope twice.
No adverse event happened. We are reporting that this vaccine was given 7 days past the beyond use date.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N001488 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA009857.
2pm 3/8/17 Fever rash mom took child to ER.  Doc- rash fever 101 in ER given TYLENOL and BENADRYL and fever and rash disappeared. Never had an appt, vomit, Pt always playful and active F/U call 3/9/17 no rash no fever no meds.
Patient stated he was feeling nauseous and had a headache. Patient was given snacks and vitals were taken by EMS. No known allergies. No past medical history. BP: 104/67. Pulse: 95. Os Sat: 98. Patient started feeling better and refused to go to the hospital by EMS.
Within 3 days of getting the vaccine i experienced fever chills lose of strength flu like systems which have lingered for 4 weeks. I'm still not feeling feel at all. I went from a healthy active lifetime feeling like I'm going to die. 3 episodes of feeling like I was going to have a heart attack.
This spontaneous case reported by a consumer, describes the occurrence of oral discomfort (feeling of a scalded mouth), tongue disorder (raised taste buds) and pharyngeal erythema (very red patchy throat) in a patient, of an unknown age and gender, 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 experienced oral discomfort (feeling of a scalded mouth), tongue disorder (raised taste buds) and pharyngeal erythema (very red patchy throat). At the time of the report, oral discomfort (feeling of a scalded mouth), tongue disorder (raised taste buds) and pharyngeal erythema (very red patchy throat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
This was a followup flu vaccine. The 1st vaccine was "Trivalent" by Sanofi, patient had no reaction whatsoever to this. This followup was a quadrivalent. Within a few hours she spiked a fever of 103.6 that lasted through the evening. Despite combinations of ibuprofen and acetaminophen, the fever was difficult to control. It persisted until about 36 hours later dropping to 102.7.
Tachycardia (HR 116 BPM); Severe High Blood Pressure (170/90 mmHg); This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Severe High Blood Pressure (170/90 mmHg)) and TACHYCARDIA (Tachycardia (HR 116 BPM)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 024m20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (allergy to clindamycin and zithromax) and Blood pressure since 01-May-2019. Concomitant products included METOPROLOL from 01-May-2019 to an unknown date and AMLODIPINE BESILATE (NORVASC) from 01-Jun-2019 to an unknown date for an unknown indication.   On 17-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Severe High Blood Pressure (170/90 mmHg)). On 31-Mar-2021 at 10:00 PM, the patient experienced TACHYCARDIA (Tachycardia (HR 116 BPM)). On 01-Apr-2021, BLOOD PRESSURE INCREASED (Severe High Blood Pressure (170/90 mmHg)) and TACHYCARDIA (Tachycardia (HR 116 BPM)) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: (High) 170/90 mm/Hg. On 17-Mar-2021, Heart rate: (High) 116 bpm. On an unknown date, Blood pressure measurement: 160/90 (High) 160/90 mm/Hg. On an unknown date, Electrocardiogram: tachycardia (abnormal) Tachycardia. On an unknown date, Heart rate: 120 (High) 120 bpm.         No treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.   This case was linked to MOD-2021-054522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Followup information was received on 11 May 2021 wherein patient contact details, conditions and dose details were added.
Donor came in today c/o pain in left arm - area has two reddened spots under injection. No further tetanus injection.
puffy red rash across my cheeks; my face got a puffy red rash across my cheeks; along with the customary arm pain; my entire body was itchy for 2 days after the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 11:45 (Lot number: FC3180) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "None. Occasional seasonal allergy to pollen." (unspecified if ongoing). Concomitant medication(s) included: CLARITIN ALLERGIC; PROBIOTIC 10. Past drug history included: Nickel, reaction(s): "Known allergies: Nickel (skin allergy)", notes: Nickel (skin allergy).; Whey protein, reaction(s): "Known allergies: Whey protien"; Lactose, reaction(s): "Known allergies: lactose".The following information was reported: RASH (non-serious) with onset 12Aug2021 12:00, outcome "recovered", described as "puffy red rash across my cheeks"; ERYTHEMA (non-serious) with onset 12Aug2021 12:00, outcome "recovered", described as "my face got a puffy red rash across my cheeks"; PAIN IN EXTREMITY (non-serious) with onset 12Aug2021 12:00, outcome "recovered", described as "along with the customary arm pain"; PRURITUS (non-serious) with onset 12Aug2021 12:00, outcome "recovered", described as "my entire body was itchy for 2 days after the shot". Therapeutic measures were taken as a result of rash, erythema, pain in extremity, pruritus with Claritin.  Additional information: Patient not receive any other vaccine in four weeks. Patient self-administered AE treatment Otc allergy meds. Prior vaccination patient not tested covid positive, post vaccination patient did not tested covid positive.  No follow-up attempts are possible. No further information is expected.
Tachycardia for about 3 minutes; shivers and general lethargy for the following day; rash onset 4 days thereafter, lasting for almost 4 weeks.
high fever (tactile) on day of vax 7 next 2 days, rash on face, chest & legs, cheeks swollen & hard to touch, pt fussy w/ dec po until 4 or 5DEC94; pt eval in clinic on 6DEC94 papular rash over ant thighs;
pain in the left arm, chill during night, ear temperature 102 K, severe joint pain at knees, ankles, wrists and elbow, , severe headache
This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (mild in 2001). On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 28th January 2019, less than a day after receiving SHINGRIX, the patient experienced headache and pain. On 29th January 2019, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On 4th February 2019, the patient experienced bruising of arm. On an unknown date, the outcome of the headache and pain were unknown and the outcome of the erythema of extremities was recovered/resolved and the outcome of the swelling arm, itchy upper limbs and bruising of arm were not recovered/not resolved. It was unknown if the reporter considered the headache, pain, erythema of extremities, swelling arm, itchy upper limbs and bruising of arm to be related to SHINGRIX. Additional details were reported as follows: The first night after the injection, the patient experienced achiness with headache. The following day, the patient had enormous red itchy and puffy left arm that extended 3 inches wide. The patient claimed that the area was red on 31st January 2019 and although the redness had improved at the time of reporting, the itchiness was unresolved. She also reported that, the area was still pink at the time of reporting and it almost looked like bruising on her arm. The reporter gave consent to follow up.
Information has been received from a physician concerning three patients over the age of 65 years old who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658450/1380U). The physician reported that the patients had injection site reactions after the injection was administered. A follow up telephone call to the doctor's office as made to obtain more information about the patients. No more information was available at this time. The outcome was unknown. This is one of several reports from the same source.
Mother reports that child had a fever 101 after getting Imm. on 3/20/2007. States @ 9:00pm on 3/21 she took him to ER with and allergic reaction to re lat thigh. States that it was larger that size of golf ball. ER MD put him on steriods and an antibiotic. States the Dr thought it was infected. States back to normal self today.
Within 24 hours of receiving the ACAM2000 smallpox vaccine by itself at a clinic, pt developed urticaria of bilateral lower legs and tongue and facial angioedema. Pt was prescribed an unknown medication and all symptoms resolved within 6 hours of taking medication. Did not recur.
I experienced fever, chills, bone pain(hips/femur), flank pain bilateral, severe headaches and nausea lasting 36 hrs.
Tuesday - started with lip and perioral swelling and tingling. Tip of tongue tingling and sore. Scratchy throat. - all progressing through the day.  Treated with 2 Benadryl before bed with fair results.   Wednesday - continued puffiness in face below the nose and around mouth. upper and lower lip swelling .  Lower lip pain, cracking and rawness.  Less scratchiness in throat. Treated with 2 Benadryl before bed.  Thursday - less facial swelling. Upper lip appears somewhat normal. Lower lip moderately painful, tight, with swelling and cracking. Treated with 2 Advil before bed with good relief.  Friday - red halo above the upper lip, less defined demarcation of lips to face. Lower lip painful, purplish in color, raw and cracking.  *of note - reacted to a less degree after my first injection on 1/3/21 but attributed it to new facial creams, however redness and soreness did not go away immediately. Treated with hydrocortisone cream at the time.