chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix given to a 7 year-old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The pharmacist reported administration of Kinrix to a 7 year old patient. Additional adverse event details were unavailable per health care professional.  The reporter consented to follow up. Additional Supportive Information: The seven-year-old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender whom since 24-JUN-2014 have received (Oka/Merck) VARIVAX, subcutaneous (lot #, dose and route not reported) which went out of temperature range multiple times. These excursions were supported. No adverse effects were reported. Additional information has been requested (correspondence containing a request for additional information is scheduled).
c/o redness, swelling (2X2 area) at site of injection. Shoulder discomfort which improved 2 days later. Denied appointment for evaluation with physician.
Episodes of flashing lights at  left eye to episodes of partial loss of vision for 48 hours ( by March 1,2  2021) . Ischemic left optic neuropathy as per retina specialist. Problem appears resolved to this date.
Information has been received from a registered nurse concerning a 19 year old white asplenic (spleen removed 06/03/1994) female student, who on 10/03/2002 at 14:15 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 637093/0802L).  The first dose was administered in 1994.  Concomitant therapy with the second dose included a dose of meningococcal polysaccharide vaccine and ethinyl estradiol (+) norgestimate (ortho tri-cyclen).  The reporter indicated that the second dose of pneumococcal vaccine 23 polyvalent had expired on 04/14/2002.  There was no illness at the time of vaccination.  Subsequently, the patient had a painful reaction in the arm that received the injection.  The patient stated that her "arm/armpit was very sore, hard, swollen" and that she, "could not use her arm very well".  Unspecified medical attention was sought and the patient was treated with cold/warm compresses and ibuprofen (Motrin).  No laboratory tests were performed.  One week later the patient recovered.  Additional information is not expected.
Patient got blood drawn and the vaccine administration, she stood from chair to go to the bathroom and fainted, with loss of consciousness for few seconds.
Swollen, red, hot upper left arm over bicep area. Given cephalexin for cellulitis.
Information has received from a general practitioner concerning a 16 year female in good health with a history of blood pressure increased 2 years ago who in January 2008, was vaccinated with the first dose of GARDASIL. No adverse effect. In March 2008, the patient was vaccinated with a second dose of GARDASIL. 24 hours after the second dose of GARDASIL in March 2008, the patient experienced severe fever 40 deg C during two days. There was no associated symptoms. She had some Paracetamol. In March 2008, she also had blood pressure at 15/8. In September 2008, the patient received only half of the third dose of GARDASIL. There was an under dose. In September 2008, the patient had blood pressure at 15/9. she had no concomitant treatment. She had recovered on an unspecified date. Other business partner numbers included: EZ008-08727 and E2008-0B737. Additional information has been requested.
Patient received the vaccine, covid, J&J, and 2 minutes later was found unresponsive in the chair, pharmacist felt for pulse, no pulse was present, when pharmacist went to lay the patient down he woke up. Said he felt fine, and mentioned a previous vasovagal incident in the past. Paramedics arrived but the patient refused to be transported to the hospital. Agreed to wait for a few more minutes, then said he feels well and left
Initial report received from a health care professional on 11 October 2013. A female patient (date of birth and age at the time of event was not reported) had received an intramuscular dose of FLUZONE HD (batch number and site of administration was not reported) on an unspecified date of October 2013. The patient illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date of October 2013, the patient developed a bleb under the skin at the injection site and it bleeds a lot. Laboratory tests were not reported and the patient had received Aspirin as corrective treatments. At the time of this report the outcome was unknown. List of documents held by sender: none
no adverse event; expired ROTATEQ (EXP: 17DEC2021) to a patient on 17JAN2022.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions or concomitant therapies provided.  On 17-JAN-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, expiration date reported as 17-DEC-2021 (exact dose and lot # were not reported) for prophylaxis (expired product administered). The reporter confirmed the vaccine was stored within recommended storage range, with no temperature excursions prior to administration. No adverse event (AE) was reported.
4 days later after the vaccine my left eye turned really red with crust and mucus coming out. I went to walk in clinic and was being treated for pink eye. I was started on an antibiotic eye drop. A day later my right eye started to have the same problem. I scheduled an appt with a eye specialist where he examined both eyes and said I had a major infection. I was started on steroid eye drops which I am still taking but seems my eyes are not getting better. I have a follow up with another specialist next week for further testing. I have been out of work due to this matter.
Twelve Moderna vaccines were given in office. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation.   Communication to patient: The Moderna Vaccine patient received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. Pt will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
patient reported a fever of 103 at home following the Pfizer monovalent vaccine  evaluated at the ER, treated with acetaminophen. Fevers reduced.
Period lasted longer than 8 days, then restarted and was very heavy and super painful for 5 more days, lots of clotts.
Pt was in the office given the vaccine at 1103am. Patient then went to work after 10-15 min of observation, with no interaction. Patient then went to the ED at 2209 with notation of Allergic Reaction. She presented to the ED with Hives and Pruritus. Notation from ED says that within 30 minutes patient broke out in a rash on Abdomen & Arms that is Pruritic. Denied swelling of lips and tongues, but felt as if something was stuck in her throat. NO wheezing, stridor, shortness of breath, nausea or vomitting. Patient is allergic to Carbofed DM which contains benadryl. However patient takes Claritin and Zyrtec PRN with no issues.
Patient reports redness and swelling at injection site.  Patient also reports injection site is hot to the touch.  Patient also reports fever.
After the second and third doses of Pfizer vaccine for COVID (last dose given Oct. 2, 2021); given 3 doses due to immunocompromised status; On Oct. 5, liver enzymes went up to 3 or 4 times previous labs; Suspected causes included meds begun in between lab results in June 2021 and Oct. 2021 (Cosentyx, Bactrim, COVID-19 vaccine series); Cosentyx later ruled out.
temp>105, 2hr of unresponsiveness & 4-5hr of unconsolable crying;
First shot no issues pain nothing. Second Shot Wednesday at 3:30, extremely sore arm around 7pm (2x worse than Tetanus shot IMO) chills and body aches around 2AM- chills resolved around 4AM. Whole body still aches (hair even hurt to shampoo), some dizziness and lightheadedness on quick motions.....7/10 migraine and I felt 50% of normal energy  12hrs later (checked temperature and was 98.9). But still could not get warm all day. . Developed a fever around 6pm (100.0)....felt 20% of normal energy shook with chills till midnight when i woke up drenched in sweat and had to change my clothes. Next day still have 6/10 migraine and 5/10 body aches. Woke up at 6AM on Friday and felt 70%. Today, Saturday feel 85% but woke up once in night soaked with sweat requiring clothing change.  Side note I am breastfeeding my 10mo old son still
approx 20 days p/vax pt devel severe vomiting on 6/10. admitted to hosp for rehydration. unable to take any po feeds. dx gastroparesis; now fed by NJ tube & no po feeds;Annual follow-up dated 09/27/00 provided no additional data.
Information has been received from a physician concerning a 6 year old (previously reported as a 4 year old) white female who on 12-JUN-2001 (previously reported as one day the week of 09-MAY-2006) was vaccinated SC on the left side with a first dose of Varivax (lot # 637974/1896K). There was no illness at the time of vaccination. On 04-MAY-2006 the patient developed shingles around the eye and face with second degree cellulitis. Unspecified medical attention was sought. On 04-MAY-2006 a culture was done that was positive for the varicella-zoster virus. She was treated with acyclovir, mupirocin (BACTROBAN), ceftriaxone sodium (ROCEPHIN), and amoxicillin (+) clavulanate potassium (AUGMENTIN). Subsequently, the patient recovered. The patient's shingles was considered to be an other important medical event. No further information is available.
I became very tired around 5pm, but had some things to do that evening, so I went on as normal. However, around 7pm, I began having cold chills & feverlike symptoms. I knew there would be side effects, so I wasn't worried.  Later, around 8:45pm, it was everything I could do to stand up right and all I wanted to do was go to bed with ALOT of blankets on. I felt like I was going to vomit throughout the next several hours. Around 3am, I was throwing up and had diarhea. I had a massive headache as well. I had several rounds of extreme vomiting for the rest of that morning, but they were just dry heaves by then.  My head hurt so bad, I was worried.  I continued to vomit several more times that day and slept on & off
Hive like rash located on wrist hands feet and stomach. Took benadryl
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced pain and discomfort. The patient received a dose on an unspecified date. The patient experienced pain and discomfort. The outcome of the events were not reported. No additional information was available at the time of this report.
2 days p/vax pt saw sl bruising around inj site of rt area & discomfort in arm;pt states bruises easily;bruising /soreness lasted about 2 wk;28NOV pt noticed large bruised area (2"x2.5") on rt arm inner deltoid area;yellowish edges, purple
Arm was swollen; Red; Feels like heat is around the swollen part; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Red) and FEELING HOT (Feels like heat is around the swollen part) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2OA) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 16-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 PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Red) and FEELING HOT (Feels like heat is around the swollen part). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Red) and FEELING HOT (Feels like heat is around the swollen part) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Child started her first period ever. Every period the last 13 months have been extremely heavy, child has been very sluggish, and no motivation to do anything. Child has had blood work to test for hereditary blood disorders. Child was diagnosed as anemic. Child started having headaches, that turned into a diagnosis of Migraines with Aura. Child has become more exhausted, with little to no energy. Child had an episode, of breathing, but no real response. After ER visit and normal MRI, child was told, likely a seizure. Child had EEG, normal results. Child has loss of appetite. Child is starting to go into depression. Child has short term memory loss, and a hard time concentrating. Child has new symptoms, almost daily.
Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Additional Details: Patient experienced swelling of both hands, and a generalized blotch rash on arm, back, and ribs bilateraly
Just was not feeling like my self all day no energy then about 1:00PM my arm started to hurt and it progressively got worst to the point I could hardly move it the pain kept me up all night the next morning I got up to go to work and took my temp I was not feeling good at all and it was 102 and my arm had a raised red spot around the injection site took some Tylenol and called the Doctor they had me go into the office @4:30PM and they told me I had Cellulitis they are treating it with Cephalexin and diphenhydramine.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Nausea-Mild, Additional Details: Patient called about 1 hour after her shot stating that she had some swelling of her face with no difficulty breathing. I recommended she take benadryl 25mg and call her md. 4 hours post injection, she called and stated that the swelling went down, she was feeling better and her md had recommended that with her next shot she take benadryl 25 mg in preperation. 2 days post injection, I called her and she stated that she was tired and nauseous but no longer swollen.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a seven-months old male patient who had the diluent of pentacel and did not mix the vaccine with water, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE for Immunisation. On 18-Sep-2018, the patient received a once 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot N022173, expiry date- 07-Dec-2018 via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate reconstitution technique as the patient did not receive the (HIB) portion of PENTACEL. 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 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. Documents held by the sender: none.
Patient stated a few hours after vaccination, when she was asleep, started having a itchy red rash starting from the top part of the neck down to the whole torso. It did not affect the hands or the legs. She stated taking some Benadryl and Zyrtec and some Aveeno Cortisone cream to relive the discomfort. The rash lasted for about 6 days and she appears to be doing better.
No Adverse Event; a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial) and NO ADVERSE EVENT (No Adverse Event) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a 17-year-old patient received a Moderna COVID-19 booster dose (0.5ML) from a vial of Monovalent 6M-5Y of Moderna COVID-19 vaccine instead of Bivalent vial).    No concomitant medications were reported.   No treatment details were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VICKS DAYQUIL [PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 16Oct2023, stop date: 18Oct2023. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. 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: Negative, notes: 3 days after testing negative (with no symptoms); Positive, notes: positive antigen tests on Day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included paxlovid from 16Oct2023 to 21Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;face red, swollen 2 1/2 hrs later;no SOB or difficulty swallowing per mom;behavior unchanged;instructed to seek med intervention;not pursued by mom;pt recovered;
Dizziness, Headache, Myalgia, Arthralgia, Fever, SkinRash, Diarrhea, Nausea Vomiting, shortness of breath,  Narrative: employee reports awaking the day after the COVID vaccine, c/o being ill to the point that she could not get out of bed for 4 days, was seen by a provider on 1/13/21.
Vaccine which were kept above -80C for 5 minutes and noticed that 2 doses were given to two patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine which were kept above -80C for 5 minutes and noticed that 2 doses were given to two patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine which were kept above -80C for 5 minutes and noticed that 2 doses were given to two patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine which were kept above -80C for 5 minutes and noticed that 2 doses were given to two patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Reporter said these patients are part of Research and their identification is unknown.  No treatment information was provided.