chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP reports that a 1 year old patient inadevertedley received Kinrix instead of Havrix; HCP reports that a 1 year old patient inadevertedley received Kinrix instead of Havrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number d24g7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received Kinrix instead of Havrix at the age of 1 year, which led to inappropriate age at vaccine administration and wrong vaccine administered.  No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
23 days, post vax, pt had macro-papular rash, a few vesicles and < 30 lesions. No fever. Mild itching. No signs or symptoms of secondary infection.
Pain, swelling,redness,and elevated temperature in right upper arm.  Cellulitis
Patient came into store and informed myself that on 10-7-09 he had received a flu shot. Since that day his arm has felt sore ( the arm feels like I still have needle in muscle). He can not use arm. His wife must put shirt on for him. I suggested patient see a physician.
experiencing a reaction at the site of injection; Soreness of the arm; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site reaction and pain in arm. On an unknown date, the outcome of the injection site reaction and pain in arm were unknown.   It was unknown if the reporter considered the injection site reaction and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix shot back and experiencing a reaction at the site of injection and soreness of the arm. The reporter did not consent to follow up. Not all information was available.  Unable to collect date of birth and other adverse event details because caller abruptly disconnected.
Temp of 39.9 degrees C and swelling of lips. Occurred approx. 5hrs after immun. Taken to ED. Given acetamophen, BENADRYL. Symptoms resolved. No tongue swelling or trouble breathing.
SEVERE BACK PAIN Narrative:  Patient states he is in bed with "severe back pain" and has not reported to work today.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: cucumbers" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "allergies" (unspecified if ongoing), notes: allergies; "anxiety" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; MONTELUKAST; BUSPIRONE. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient took other medications in two weeks. The patient was given COVID-19 treatment with anri viral drug from 19Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient's DOB and age on the consent form is 11/16/2008 and 12. Based on that information the vaccine was administered. On billing the patient's insurance for the administration of the Vaccine, the insurance rejected saying that the DOB was not correct and that it was 11/16/2009 on their system. This is why I am reporting this incidence.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient.  Neither medical history nor concomitant medications have been reported.  On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine.  The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.
This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of a GARDASIL (dose, route, lot # and expiration date were not reported), and 1 week after, on an unknown date, the patient inadvertently received the second dose of the GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as no consent to contact the reporter was provided.
About 5 hours after injection. Site got red and swollen. Very painful. 2 days later-arm still swollen, rash has developed and started to spread down arm towards elbow, pneumo vac site, recommended MD visit.
Fever; This is a spontaneous report from a contactable consumer via Pfizer- sponsored Program. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Aug2021 patient experienced fever after getting the 1st dose of the covid-19 vaccine. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt had reaction to unknown vaccine several years ago, had flu vaccine last year without any reaction. Once vaccine was administered, pt became hot and passed out. Woke up feeling ok and able to communicate effectively. Patient moved while unconscious, unknown whether or not convulsions.
Patient had a reaction to the Prevnar 13 vaccine about one week after getting the shot. The reaction was red, and was a large circular (2 inch diameter) wheal/rash on the right deltoid.
Arm sore to move. Golfball size knot. Very hot to touch. Reported on Friday 9/1/2017 patient told to call Dr if does not get better/worse and use a warm compress for swelling.
Vaccine given 6/13/12 - child woke up at 130 am 6/14/12 projectile vomiting x over 1 hour. "Very hot" but mom did not take temp. Would not keep TYLENOL down. Remained fussy throughout 6/14/12 & had temp 6/15/12. Infamy doing better/eating/sleeping.
fever 101-102, fatigue, headache, sore throat, arm soreness, nausea
Tremendous pain, stabbing muscle pains, fever, chills, exhaustion, vertigo, sensitivity to light
Body Temperature 100.2F, Headache, Chills, Sweat  - Continued for 2.5 days
menstruation issue, heavy blood clots, its not even her regular cycle yet.; she is having heavy bleeding for days; This is a spontaneous report from a contactable consumer (patient's Mother) reported for a patient. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was 33 years) at a single dose for Covid-19 immunisation. Medical history and concomitant medication were not reported. The caller called for her daughter who received the first dose of the Pfizer covid vaccine and she was having menstruation issue, heavy blood clots, went to see doctors but they were not sure what's going on. The caller wanted to know if menstruation issue has been reported. Caller stated that she was having heavy bleeding for days and its not even her regular cycle yet.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After a few days my left upper arm was blothchy with red warmer areas, this morning 4/7/21 I have a 4 diameter circle of redness that is warm to the touch and slightly itchy.  No ID'd swollen lymph nodes, no fever.  Two weeks seems a bit long after the injection to now have this.
Pain/ Soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    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 PAIN (Pain/ Soreness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain/ Soreness). At the time of the report, PAIN (Pain/ Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
1 of 3 pts immunized who exp a nodule @ the DTP inject site; also had 1-22" area of induration & erythema; event occurred in pt w/in 48 hrs of vax;
Adhesive Capsulitis, ongoing (unresolved) Physical therapy, cortisone injection
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-JUL-2007, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-MAY-2016, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
About 8-9 hours after shot around 9:00 PM on 9/14/22 , I developed 102.4 fever with chills and body aches.  I took two, 200mg Advil capsules to help with fever and pain.  Fever broke around 3:00 AM, 9/15/22.  During the day on 9/15/22, fever did not return, but i still was very tired and achy.  I have a few red welts and pain at injection site (upper left arm); the pain spans around my entire upper arm area and armpit.  I had difficulty sleeping the last 2 nights due to general all over discomfort.  Today 9/16/22 is better than yesterday but still do not feel quite right, with a slight headache.  Body aches are mild now.
Red swollen area of thigh from knee to inguinal region on leg above site. Symptoms began 2 hours post and got worse overnight.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccines on 2/11/21, 3/11/21, and 8/31/21. On 12/20/21 presented to ED referred by cardiologist for possible pleural effusion. Admitted for Acute respiratory failure with hypoxia and COVID PNA. PMHx CAD, HTN, CKD, and Waldenstroms Macroglubinemia. Respiratory status cont'd to decline -> intubated. Tx'd w/dexamethasone, antibiotics, paralytics. Expired 12/30/21.
mild headache; mild shivering; 99.5 fever; slight tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on unknown date. Please refer the case US2020AMR187682.).   On 16th September 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, 1 days after receiving Shingrix, the patient experienced headache, shivering, fever and tiredness. On an unknown date, the outcome of the headache, shivering, fever and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, shivering, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 2nd dose the patient experienced the mild headache, mild shivering, 99.5 fever and slight tiredness.  The reporter consent to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR187682:same reporter
Hot below injection site; Itching below injection site; Redness below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot below injection site), VACCINATION SITE PRURITUS (Itching below injection site) and VACCINATION SITE ERYTHEMA (Redness below injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot below injection site), VACCINATION SITE PRURITUS (Itching below injection site) and VACCINATION SITE ERYTHEMA (Redness below injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot below injection site), VACCINATION SITE PRURITUS (Itching below injection site) and VACCINATION SITE ERYTHEMA (Redness below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment for the events included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Initial additional
Day 9 developed redness, swelling, heat, hardness & itching at injection site
Approximately after receiving vaccine 10 minutes later father and brother brought patient back to pharmacy. Father was carrying patient and said she felt faint. Patient appeared pale and clammy. Had no breathing difficulty but had visual disturbances. Paramedics were called. Vitals were in normal limits but blood sugar 62. Patient recovered within 15 minutes and felt better.
Severe chest pain,  shortness of breath,  severe headache & fever. Went to an Emergency room on June 1st and was diagnosed with Pericarditis. Was released the same day and given IBprofen & Colchicine as an antiinflammatory for the fluid buildup around the heart. The pain continued despite medication returned to ER on June 3rd, 2021. Was hospitalized through June 8th. Was released.  Symptoms and pain continued after release. Revisited ER on June 10th, 2021. At this point, ER doctor reevaluated all symptoms and after further consultation determined the immune system was causing adverse symptoms due to the Covid vaccine and started new treatment to suppress the immune system. This proved to help with pain and symptoms.
This is a spontaneous report from a contactable Pharmacist reporting on behalf of a patient. An over 65 year female patient of an unspecified ethnicity received PREVNAR 13, L(ot # M13068, Expiry Date Apr2017, NDC #  0005197102) via an unspecified route of administration at single dose on 08Sep2016 for immunisation. The patient medical history was not reported. Concomitant medications included flu vaccine on 08Sep2016 for immunization. On 10Sep2016 the injection site started itching and turned red. She put cold rags on it and took BENADRYL which didn't do anything. She has been using Benadryl for several days.  Reporter has not seen a reaction like this before. She had no fever, and did not feel bad. The area was not swollen, just red and itches and burns. It was the size of a small orange and started at the top of her arm down to a little below the injection site. The events outcome was unknown.
fever of 102 degrees Fahrenheit; nausea; tiredness; Blood pressure was up; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 12May2021 11:20 (lot number: EW0173) at the age of 73 years old as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 virus on Jan2021 (completed his isolation and recovery; came out of quarantine on 10Jan2021), ongoing atrial fibrillation (Diagnosed 20 years ago in 2001), ongoing parkinson's disease (Diagnosed 12 years ago in 2009). There were no concomitant medications. The patient had no history of previous vaccination with the Pfizer vaccine considered as suspect. No vaccines administered on the same date with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. No relevant tests reported. When the patient had the COVID-19 virus in Jan2021, the patient completed his isolation and recovery and then waited the suggested 90 days until he received his first dose of the Pfizer COVID-19 vaccine. After he received his first dose of the vaccine (symptoms began about 12 hours after the shot, at the same time on the evening of 12May2021), he had a "bad reaction" which included fever of 102 degrees Fahrenheit, nausea, tiredness and his blood pressure was up so he went to the hospital. The patient was admitted to the hospital for 3 days (from 14May2021 to 17May2021) and then released. He was scheduled to receive the second dose of the vaccine on 04Jun2021 (23rd day after the first dose) and he would like to know if it was advisable to proceed with the second dose or not. The patient wanted to know how effective was receiving only the first dose of the Pfizer COVID-19 vaccine if he chose to forgo his second dose. The patient stated that he listened to all these people on the news one day, they said to get it, then one day, they said don't get it. The patient mentioned that they said wait 60 days then they said 90 days, so he had to make a decision and then waited 90 days after he was clear of the virus. The events required a visit to the emergency room but not to the physician's office. The patient received unspecified treatments as a result of all the events. The patient recovered completely from all the symptoms reported on 16May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Patient stated that Ideopathicthrombocytopenia, Brusing occured all over body about 2 weeks after receiving vaccine (03/31/2021). bloodwork done on 04/19/21, and was tols that blood platelet dropped to 5,000 and was sent to ER same day. Decadron was administered, and was sent to hematogist, was given 3 IV infusions of Decrdeon, was given 3 does of rituxan over a 3 week period along with steroid infusion, was also on oral steroid, and blood platelet have improved.
Thigh L red, swollen, warm to touch TX: oral antibiotics Thigh 6" in diameter. TC to clinic. IV antibiotics were given in ER prior to pt coming to clinic.
This literature marketed report has been received from the authors of a published article, titled as stated above and refers to a 57-year old female patient. Her medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, she presented with dyspnea, wheezing, throat tightness and worsening angioedema of the face and was admitted to the critical care unit, where an extensive review of her history did not reveal any suspicious ingestion or skin exposure. The patient was treated with parenteral antihistamines and high dose methylprednisolone. However, her symptoms including angioedema persisted, with further development of hives and lip paresthesia. Intermittent epinephrine intramuscular (IM) injection provided temporary relief. Further exploration of her history revealed that the patient received the hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided) vaccination two days prior to onset of symptoms. Treatment with systemic glucocorticoids continued for 2 weeks with a combination of diphenhydramine, famotidine, cetirizine, montelukast, and hydroxyzine added. The outcome of anaphylactic reaction and angioedema was unknown, however it was also provided that she slowly improved on this regimen. The reporter considered protracted anaphylaxis and angioedema to be related to hepatitis a vaccine, inactivated (manufacturer unknown). Upon internal review, the events of anaphylactic reaction and angioedema were considered to be medically significant.
Nurse gave dose from the Moderna 6 years to 11-year-old COVID-19 vaccine vial instead of for Moderna 6 months to 5-year-old. Dose given was correct at 0.25mL. Parent contacted. We are awaiting her to return voicemail message.
Information has been received from a nurse practitioner concerning "a few patients" (ages and genders unknown), Who, on an unspecified dates, were vaccinated with a dose GARDASIL. Subsequently the patients experienced pain at the injection site. At the time of the report, the outcomes of the patients were unknown. Additional information is not expected.