chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 11 year old daughter who on 16-OCT-2008 was vaccinated with her first dose of GARDASIL (route and site not reported). Concomitant therapy included flu vaccine in the same day. On 16-OCT-2008, later that evening the patient experienced vomiting and nausea and was hospitalized for at least 4 days. Patient was vomiting almost every half an hour for those days. When the patient was brought home, she started vomiting again and was hospitalized the second time for 2 days. The patient was recovering. The patient was tested for computed axial tomography (cat scan), magnetic resonance imaging (MRI) and blood test with no result. Follow-up information was received from a registered nurse. The nurse stated that the patient received dose 1 of GARDASIL 0.5 ml IM on 16-OCT-2008. The patient was treated with Phenergan and her symptoms were almost completely resolved. Additional information has been requested. Follow up information was received from the patient's mother concerning her 11 year old daughter. The patient had symptoms of respiratory abnormality at the time of vaccination. On 16-OCT-2008 the patient was vaccinated with GARDASIL (lot number 659657/1487U) IM into her left arm. Concomitant therapy included FLUZONE (lot number U2761AA) IM into her left arm. On 17-OCT-2008 the patient experienced vomiting and was hospitalized. The patient had stayed in the hospital for 4 days. Complete blood count. Streptococcus. basic metabolic panel, urinalysis, chest poster-anterior/laterial and gastric occult blood were performed with no result reported. The patient recovered at the time of reporting. Additional information is not expected.   1/22/09 Received PCP medical records of 10/16-10/25/2008.  Records reveal pt in state of usual health on day of vaccination.  Later same day, parent had to pick up from school due to SOB, weakness & dizziness.  Seen same day by PCP & dx w/allergic rhinitis.  Tx w/antihistamines.  Developed vomiting.  RTC 10/20 for same & sent to hospital.  RTC 10/24 s/p hospitalzation.  Concerns for PVCs noted in hospital & continued lightheadedness, otherwise feels well.  Referred for Holter monitor.  Recurrent vomiting 10/25 & was readmitted to hospital.  1/22/09 PCP records included hospital medical records of 10/20-10/23/2008. FINAL DX: vomiting w/dehydration & viral exanthem Records reveal patient experienced bilious vomiting x 5 days, poor appetite, lack of sleep, fatigue.  Had been seen in PCP office previous week for viral infection w/SOB & dizziness. In hospital had nausea & diarrhea.  On 3rd day in hospital developed facial flushing & rash.  1/30/09 Received additional hospital medical records of 10/25-10/26/2008. FINAL DX: dehydration, bilious vomiting & sinusitis Tx w/IVF & oral antibiotics.  Improved overnight & d/c to home on continued oral antibiotics w/PCP f/u.
Muscle cramp, charlie hoarse on calf and muscle weakness  in legs, went in the following day to doctor to check for blood clot [ 03/03/2021] this was before all the news about potential clotting.  Blood was drawn to check, came back ok.  Since that time I have had erectile issues., which were never an issue before.
inadvertently administered an additional dose of adacel today with no adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11-year-old male patient who experienced inadvertently administered an additional dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] today with no adverse event.   The patient's past vaccination(s) included Adacel in NOV-2021. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for Immunization.  On 28-Mar-2022, the patient received a dose of suspect Adacel (lot U7276AA) 0.5 ml via intramuscular route in the left deltoid (formulation, strength, expiration date: unknown) as prophylactic vaccination.  On 28-MAR-2022, (latency same day) the patient reports inadvertent administration of an additional dose of adacel today with no adverse event (extra dose administered).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Miscarriage on 01/03/21  (due date 08/08/21) 2 previous pregnancies with live births (2006,2010)
I developed tinnitus about a month after receiving a Moderna booster. I had originally received a Janssen vaccine in June of 2021.
6 days after receiving the vaccine I began to feel I'll. My arms were numb, I was sweating profusely, and was having a bad headache while at work. Suddenly I began to get tunnel vision and felt as if I was about to pass out. I was transported via ambulance to Medical Center where I was given IV and medication to treat vertigo and massive head pain/migraine. Since that day I have continually dealt with severe neck and head pain leading to migraines causing visual issues (auras and blind spots), vertigo, and nauseau.
ever since the 1st dose, he has had diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (ever since the 1st dose, he has had diarrhea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (ever since the 1st dose, he has had diarrhea). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (ever since the 1st dose, he has had diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Diarrhoea; Vomiting; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ESCITALOPRAM OXALATE (LEXAPRO) and CELECOXIB (CELEBREX) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced DIARRHOEA (Diarrhoea), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (Fatigue). On 11-Apr-2021, VOMITING (Vomiting) and NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA (Diarrhoea) had not resolved and FATIGUE (Fatigue) outcome was unknown.            Treatment included gatorade and water for diarrhea.   For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Left leg swollen at site of injection. Mother took him to ER, said to use cold compresses, hydrocortisone cream on leg.
Puffiness both eyes with conjunctival swelling & redness & nasal congestion - 4/22/08.  Treated with Patanol eye drops & Benadryl.  4/23/08 - Blotchiness of face & hives - papuloerythematous rash over buttock.  Treated with Claritin/hydrocortisone.
Fever up to 103 F, intense fatigue, dizziness, vivid dreams, joint pain, body aches,  bone pain (especially in the long bones of the leg), waves of nausea, diarrhea, loss of appetite, and severe headache/pain when I moved my eyes. This lasted for 2 weeks.
Pt rec'd Fluzone vaccine in same arm as IPV on 11/10/02. that night, side red + swollen. Today, entire upper arm swollen, hot + red localized reaction w/ second degree cellulitis
Menstrual period started day after the vaccine with both shot 1 and shot 2.  I haven't had a menstrual period in 3 years until I received shot 1 and then again with shot 2.
Patient came to pharmacy 2 days after vaccination with red rash at site of PNEUMOVAX injection. (Right arm). No fever. No pain. She received no treatment.
Extreme muscle and body aches, fatigue, nausea, loss of appetite, fevers every four hours, coughs, sore throat. Only took TYLENOL for fevers.
Fainted, fell and hit head on ground. Contusion to lip. EMS responded on scene.
Right after the 2ND  vaccine was administered I felt a warm feeling all over my body which resolved in a few minutes . Then that night my arm was  very sore and warm  where the injection was given. It was difficult to lift my arm. Also severe body aches and fatigue. Then I started to have a  severe headache, head pressure and ringing in my ears . Took my blood pressure and it was 145/98, 155/101 and 160/100. I am monitoring it daily and it has not been below 147/92 and as high as 163/97. I have never had a problem with my blood pressure before.
Vaccine adm 07/12/12. No allergic reaction or any acute event in clinic. 07/13/12 - Fever up to 102 degrees F. 7/14/12 - Fever & rash on face and hands - beginning to peel. 07/16/12 - office visit - no fever. Dry red papules over pre-existing eczema patches elbows, knees, eyes & face. Also noted 2-3 patches on throat. Ref'd to Dermatology. Differential Dx = Herpes 'Eczema herpeticum' - Coxsackie disease. DFA fine lesion by Derm 'negative' for Herpes Simplex. Parents left for another country same week with child. Mother states it took 2 weeks for rash to resolve and she remained 'very itchy' during this period. Approximately 1 week after arriving in another country her 'eyes were swollen' -> take child to ER where she received IV steroid and ATARAX by mouth. Eye swelling took 4 days to resolve. Mother is concerned that above sequence of events may be related to Typhoid vaccination.
Pfizer-BioNTech COVID-19 Vaccine EUA.   Shortly after injection, during the initial 15 minute waiting period until 5 or 6 hours later, there was a weird taste in my mouth and a tightness in the back of my throat, as though the glands were swollen and constricted my throat making it uncomfortable to swallow.   There was no pain.  Between a rating of 1 to 10, the discomfort level was about 5.  I also felt weakness in my whole body and walking felt strange and lasted for the entire day.  The injection site has mild soreness even 24 hours later.
Cough  Fatigue  Muscle or body aches  Congestion or running nose  Diarrhea
This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS-MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown".; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event thrombosis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300272365 Same article/drug/event, different patient;US-PFIZER INC-202300272367 Same article/drug/event, different patient;US-PFIZER INC-202300272366 Same article/drug/event, different patient;
Information has been received from a physician concerning a pt who about 2 weeks ago, in 08/03 was vaccinated IM from a multidose vial with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed localized swelling around the injection site which was described as painful, ring-like cellulitis and a fever of 102 degrees F. Subsequently after a week, the pt had a complete recovery and was in "good" condition. Medical attention was sought and the pt was placed on an antibiotic (unspecified) for the cellulitis. No further information was provided. No product quality complaint was involved. It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES # 0309USA01513, 0309USA01723, 0209USA01724, 0311USA02365 & 0311USA02366). It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with the pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
they have received expired doses of FLUZONE HIGH DOSE QIV with no reported adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves 5 patients of unknown age and gender who received expired doses of fluzone high dose qiv with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (expiry date: 20-JUN-2022), (lot number, strength was unknown) via unknown route in unknown administration site as Immunization with no reported adverse event (expired product administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
About 8-10 hours after the second covid dose, I woke in the middle of the night with chattering teeth and soaking wet from sweat.  This symptom would come and go for a couple days but lessened over time, none as bad as the first episode but still significant enough to note.  I had a headache for several days and my skin was generally painful to touch for about four days along with muscle pain in my larger muscles.  I experience lethargy for about five days and it was about a week until I felt decent and perhaps a month until I felt like all of the effects had worn off.
Fever 103.5, Rash (small red) over entire body (torso, limbs, face, butt, very concentrated on neck), lethagy, poor appetite, very fussy, crying.
Inflamed; The arm was sore; had a sensation of warm to touch; circled the redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflamed), PAIN IN EXTREMITY (The arm was sore), SKIN WARM (had a sensation of warm to touch) and INJECTION SITE ERYTHEMA (circled the redness in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INFLAMMATION (Inflamed), PAIN IN EXTREMITY (The arm was sore), SKIN WARM (had a sensation of warm to touch) and INJECTION SITE ERYTHEMA (circled the redness in the injection site). At the time of the report, INFLAMMATION (Inflamed), PAIN IN EXTREMITY (The arm was sore), SKIN WARM (had a sensation of warm to touch) and INJECTION SITE ERYTHEMA (circled the redness in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter No treatment was reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine given Friday, patient noted burning/itching and redness to injection site on Sunday.  Outlined area and monitored, noting it increased in size and intensity by Monday so went to ED.  Was eval and she reports she received IV Vancomycin as she does "not do well with oral antibiotics" but dose stopped half way through due to itching to scalp and she was given benedryl and sent home on oral clindamycin.  Today she is feeling slightly better but continues with a golf ball size welt in injection site.
A few hours after the injection I noticed that my arm was itchy below the injection site.  When I looked I saw some large raised red areas. I took an Allerclear tablet and the itchiness subsided.  Since then the raised red spot is much smaller, about the size of a 50 cent piece and the itch is mostly minimal although today it is a little more intense. This is not a serious problem, but I read that it seems to be a known reaction and wanted to contribute to the information base.
Severe apneic and bradycardic episodes requiring bag and mask. Intubated infant and now on a ventilator.
Noticed pain immediately upon injection which has progressed to include shoulder left.  Left hand joints also "achy".  No signs of infection, no numbness or tingling.  So hard to raise arm above shoulder level.  Had not prescribed 11/21 ice and anti-inflammation worsened.  Has not seen MD. Unable to reach for further follow up.
injected Tues A.M ; napped in afternoon did not sleep Tues, Wed., Thurs.,  slept 4 hours total Fri.  Edema resurged after antibiotic ceased for 4 days, (swelling and water retention)
COVID positive after first dose; Congestion; Cough; Loss of taste and smell; Loss of taste and smell; Headache recurrent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID positive after first dose), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion) and COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (Headache recurrent). On 30-Mar-2021, the patient experienced AGEUSIA (Loss of taste and smell) and ANOSMIA (Loss of taste and smell). On 31-Mar-2021, the patient experienced COVID-19 (COVID positive after first dose), NASAL CONGESTION (Congestion) and COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID positive after first dose), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough) and HEADACHE (Headache recurrent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  COVID-19 test was positive on 31-Mar-2021 and 07-Apr-2021.
Patient noticed redness, pain and heat at sight of injection. At routine dr's appointment, showed dr who prescribed Dicloxacillin for cellulitis.
There was an excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from freezer) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis. The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Farhenhit and maximum 5.7 degree Farhenhit. The excursion duration was 6 minutes. On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contain updated contact information.
RED SWOLLEN AREA 2 INCHES BY THREE INCHES. CRYING, FEVER, LOSS OF APPETITE, FEVER ONGOING 103.5 ADMIN. TYLENOL AND ADVIL ALTERNATING EVERY 3 TO 5 HOURS
Complained of overall muscle aches throughout body which started about 3 days after receiving flu vaccine. It worsens after dark and causes pain and sleeplessness at noc. Treated with a 1 week course of Prednisone taper dose and now on Prednisone 1 X 1 day X 30 days and Vioxx prn. Dx'd with Polymyalgia Rheumatica. MD states that she feels that signs and symptoms are unrelated to the flu vaccine.
Patient was given adult dose of Hep A, Instead of pediatric dose.  Patient did not show any signs or symptoms before leaving the office.