chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone HD was administered but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event; Fluzone HD was administered but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old female patient who was administered Fluzone HD but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ904AB and expiration date: 30-Jun-2023) at an unknown dose via unknown route in unknown administration site for immunization.  On 29-Aug-2022,the patient developed a non-serious  event of fluzone hd was administered but vaccines had been in transit too long and were not suitable for use, administration post excursion with no reported adverse event (poor quality product administered)(latency: same day) (product storage error).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Unknown for both events     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.
Information has been received from a physician concerning a 70 year old Japanese female with high blood pressure and a hx of adverse reaction to Lopid, Colestid, Lozol, Esidrex, Dyazide, Harmonyl, Procardia, Questran, Zestril who on 22OCT2003 at 10:00 am was vaccinated SC in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included losartan potassium HCTZ, Hydrazine. Tenex, potassium chloride, Betagan, Xalatan. ON 25OCT2003, the pt developed redness and swelling where the shot was given on the arm and had neck pain on the left side. It was also noted that the pt had not recovered and the neck was still sore as of 27OCT2003. Unspecified medical attention was sought and a prescription drug was required. A product quality complaint was not involved. Follow up information was received from a registered nurse which indicated that on 22OCT2003 at 3pm, five hours after injection, the pt developed swelling and redness. The next day there was redness and swelling still . The pt developed left sided neck pain a day later and could not put her head down. It was noted to be painful. The next day the pain on the left neck traveled to the right side of the neck. the pain gradually subside don 04NOV2003. The pt was considered recovered on 04NOV2003. The physician also reported that tow other pts experienced similar rxns. No further information is expected.
pt woke between 12 & 130AM crying, t105.2 R;cried all noc x day;rt thigh swollen & red;temp 102-103 all day;parents giving APAP & motrin q 3hr;to see MD 17APR;
On 9/17 (2 days after shot given) pt. presented with quarter - half dollar size red itchy spot at injection site.
Severe hives all over body. Has occurred after each booster (dose 3 in November 2021, and now dose 4 in November 2022)
1st dose on: 03May2021 and 2nd dose on: 14Jun2021; Patient received Moderna Covid-19 vaccine at age 16; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on: 03May2021 and 2nd dose on: 14Jun2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on: 03May2021 and 2nd dose on: 14Jun2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16). On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on: 03May2021 and 2nd dose on: 14Jun2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.   This case was linked to MOD-2021-101703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains no significant information.
Patient was in the observation area when the incident occurred. He refers to feeling discomfort when swallowing after the administration of the vaccine. Doctor was consulted and ordered to administer 50mg of BENADRYL P.O.
Warm to touch at injection site, Burning at injection site, Mouth tingling and burning, Facial and neck paresthesia (tingling, burning, itching),  Scalp itching. Started approximately 1 hour after injection and lasted for several hours.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt has longstand allergic rxn Hx, with use of epipens. Pt refused Bendaryl and also DID NOT want  EMS called.  She was a nurse and very capable of handling the symptoms.  She called her allergist who gave her an rx for epipen and prednisone to ensure the rxn would remain under control.
1 week after vaccine given, patient noted 2" diameter tender nodule at site of injection. 6 days after first noted, area "pea" size and tender. No erythema.
Arm soreness 4-24 hrs after.  Vomiting, nausea and headaches approx 48 hrs after.  Could not keep water down.  Had to pull out old anti nausea prescriptions
respiratory problems; This is a spontaneous report received from a non-contactable nurse.  A 2 year-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) at the age of 2 years as, single dose for immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: Respiratory disorder (non-serious), outcome "unknown", described as "respiratory problems".  No follow-up attempts are possible. No further information is expected.
pt recv vax 8JAN98 & 10JAN97 pain, stiffness in rt shoulder, elbow & hand, used heavy doses of Ibuprofen for 4 days;better p/4 days;
He got his vaccine, was ok.  Went to bed, woke up and he could not lift his head like somebody hit him in the head with a hammer.  The left side of his face was swollen and he could not open his mouth as it was sore, and thought he had an abscessed tooth.  He called the dentist and informed them that he could not open his mouth and they saw him that day.  When he got there they x-rayed his mouth and told him that there was nothing wrong with his teeth.  She checked his teeth out and asked her why his jaw was sore and she gave him a prescription for some antibiotics.  He took those and he keeps getting things swelling up all over his body and has extreme itching all over his body, his hand is sore and he cannot open and close it, his jaw is still swollen and sore and it's been 15 days.  The bumps/hives are all over his body, his stomach, his arms, his hands, his legs and itch very bad.  He did not have any of these symptoms until he got the vaccine.  Each night he swells up and it's driving him crazy.  He is unable to sleep as his hands feel like they are on fire and they keep itching.    The first four vaccines his arm was sore that he could not lift it, and a slight fever, but nothing more than that.  These symptoms stopped after a few days, but this time it's crazy.
Developed wheezing & SOB in PM after receiving 2nd hep B vaccination on this am. Breath sounds tight. Pulse 96 - RR 26, BP 142/96. Taken to ED per wheelchair.
Slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight soreness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0211L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Slight soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Slight soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medication included statin.   This case was linked to -MODERNATX, INC.-MOD-2021-066954 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-066954:2nd dose
Narrative: Headache, Myalgia, Fever & NauseaVomiting
Presented with cough and SOB. The patient completed 5 days of remdesivir. She completed a 14 day course of intravenous meropenem. She completed intravenous dexamethasone and nearly completed the subsequent oral taper with only a few more doses planned post-hospitalization as below. The patient also completed 18/21 days of isolation from the date of diagnosis.
Patient reports 01/09 and 01/10 feeling body aches, fatigue and a sore arm but the evening of 01/11 he developed full body hives after taking aspirin.
Woke feeling lousy; Major chills, Teeth chattering; Quickening pulse; Sore arm last night where he received the jab; Tiredness; Light headache/Headache intensified; This is a spontaneous report received from a contactable reporter (Consumer) from a sales representative. The reporter is the patient.  A 54 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "Sore arm last night where he received the jab"; FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset Apr2021, outcome "recovering", described as "Light headache/Headache intensified"; MALAISE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Woke feeling lousy"; CHILLS (non-serious) with onset 17Apr2021, outcome "recovering", described as "Major chills, Teeth chattering"; HEART RATE INCREASED (non-serious) with onset 17Apr2021, outcome "recovering", described as "Quickening pulse". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had sore arm last night where he received the jab, tiredness and light headache. He woke up feeling lousy, headache intensified as the morning progressed. 24 hours after jab, he started having major chills, teeth chattering, and quickening pulse. Symptoms were lessening one hour after they started.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Approx 12 hours after receiving vaccine injection I experienced extreme chills with extreme shakiness and trembling for approx 6 hours. Fever of 100.2 F . Extreme malaise and fatigue lasted for approx 36 hours. Pain at injection site, headache and joint pain for approx 36 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 04Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Patient reports delirium and confusion for two days after receiving Pfizer COVID vaccine. He states he is fine now and back to baseline. He did not seek medical care during this time.
had them 3 times since my vac.shot/Suspected vaccination failure; had them 3 times since my vac.shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them 3 times since the vaccine shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
UNUSUAL SENSATION OF ELECTRICITY IN HEAD; FLU LIKE SYMPTOMS WHICH WERE HARSH; RASH ON STOMACH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unusual sensation of electricity in head, flu like symptoms which were harsh, and rash on stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms which were harsh, unusual sensation of electricity in head and rash on stomach was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Puffy face, heavy headed, heaviness in arm and dull. Administered BENADRYL 12.5mg 3 tsp. Felt better with above meds.
bleeding in the brain after vaccination; This spontaneous case was reported by a nurse and describes the occurrence of CEREBRAL HAEMORRHAGE (bleeding in the brain after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 CEREBRAL HAEMORRHAGE (bleeding in the brain after vaccination) (seriousness criteria death and medically significant). The reported cause of death was bleeding in the brain after vaccination. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Retired nurse read something online where there was a case of bleeding in the brain after vaccination and consumer ended up passing away.  No treatment medication was reported.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious AESI of cerebral haemorrhage after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient experienced bleeding in the brain after vaccination and eventually passed away on an unspecified date. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious AESI of cerebral haemorrhage after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The patient experienced bleeding in the brain after vaccination and eventually passed away on an unspecified date. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: bleeding in the brain after vaccination
Petechial rash on neck - spreading to trunk/extremities on 2/27. Also diagnosed with RSV 2 wks ago = Dx with Otitis Media about 1-month ago- Rx with amoxicillin.
Itchy face hours after vaccination took Benadryl, Less then 12 hours after vaccination woke up with ongoing body aches and pain, soreness at vaccinated arm
Pain in left armpit, swelling in left armpit starting the day after the shot that got worse over the next few days.   Pain radiated down from left armpit towards wrist. Booster shot was on Tuesday Jan 4, and Sunday Jan 9, pain was almost gone.  I took Ibuprofen / Tylenol but it didn?t help the pain much.
red, swollen, raised 2 inch by 1.5 inch area below the injection site; swollen, raised 2 inch by 1.5 inch area below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z, expiry date 5th November 2021) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose on an unknown date).   On 20th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced erythema and local swelling. On an unknown date, the outcome of the erythema and local swelling were unknown.   It was unknown if the reporter considered the erythema and local swelling to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed an extremely red, swollen, raised 2 inch by 1.5 inch area below the injection site. The reporter was consented to follow up.
Sudden onset of rapid heart rate (up to 175 bpm), nausea, dizziness, cold sweat, and weakness.  Tachycardia lasted more than 2 hours. Treated in the Emergency Room at Hospital.  Given an intravenous push of adenosine to reset heart rate.  Diagnosis: Supraventricular tachycardia, nonsustained Prescribed: Metprolol tartrate (lopressor) 25 mg for recurrance
Mom noted 3 fluid vesicles on inject site x2 days.  No tx & resolved.  31Aug91 irritable & no tx; 01SEP91 swollen w/ welts, looked scalded to mom, itching, pruritic urticaric.  Given Benadryl, resolved slowly.
Got shot on 3/23 at 630pm,  On 3/27 woke up with 100 temperature and body aches.  Took 2x Tylenol and symptoms went away in 2 hours  On 3/28 woke up with 103 temperate and severe body aches/chills.  Took 2x Tylenol and symptoms went away later in afternoon
Patient said she developed a rash and whelps in the area the shot was given and a sore arm the day after the shot.
22Aug89 tp vax w/ 2nd hepta B;  devel pain in posterior cervical area of neck.  Tx w/ APAP. Lab revealed neg titer.
Information has been received from a  physician concerning a 6 month old patient who was vaccinated with a dose of Rotateq. In approximately September 2006 the patient developed intussusception. Medical attention was sought in the physician's office. The outcome was unknown at the time of this report. There was no product quality complaint. Upon internal review, intussusception was determined to be an other important medical event. This is one of several reports from the same source. No further information is available.
A report has been received from a Health Professional concerning, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 31-Oct-2013. It was reported that FLUMIST quadrivalent was inadvertently administered to a pregnant woman which started on 31-Oct-2013. The outcome of the event of inadvertently administered to pregnant woman is unknown. The patient was pregnant and the pregnancy outcome was unknown. The report was considered to be non-serious. Follow-up of insignificant information received AstraZeneca/MedImmune on 22-Nov-2013 from health professional was provided lot number, and expiration date of FLUMIST quadrivalent.
Pt presented 3 days after shot w/red, itching, warm spot where shot was given. Told pt to take IBU & use hydrocortisone. ZOSTAVAX, ADERS.
Id reaction: the next day, she developed a fine papular eruption on face, behind ears, on the front of the neck, back of the neck and upper back.
Feeling great prior to booster shot. Had injection at 1:30. Around 8 pm that evening had tachycardia and was in atrial fibrillation as confirmed on ECG.
About 4 days after the booster shot I started to feel a small burn in my lower right calf, thought it was a muscle ache. On Dec 6 I told a few friends about it, and over the next few days it slowly moved up from my foot, low calf to midcalf. On Saturday Dec 11, 2021 I went to the Emergency room and was diagonsed with Deep Vein Thrombosis.
LT thigh got swelling & redness down to knee, slight warmth to touch.  Pt very irritable - cried non stop - gave TYLENOL & MOTRIN - cold pack.  Father said that crying began 3 hours after left office - then began crying non-stop.
My tips of my fingers and toes immediately began to tingle and two toes went numb on my left foot.  It began on 4/8 to present.  At night my right hand and arm pain so bad to where I cannot lay on my right side for long, or the tingling intensifies.