chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient recieved 2nd COVID-19 vaccine (Pfizer) on 3/2/21. About one month later, lost sense of taste and complained of tongue pain when eating spicy foods. Was seen by dentist, dentist dx his tongue with inflamed papilla. PCP treated with bethametsone cream. Sx have not resolved as of this reporting.
Received injections around 11:00AM at 1PM same day,4/7/04,became faint feeling, dizzy, temp 102 degrees, joints aching-back hurts, neck hurts, nauseated, not eating, back and spine hurts. Seen ER. On 4/8/04 and 04/11/04.  4/12/04 seen ER. 04/13/04 phone call from pt "feeling a little better, still fever"
pt recvd vax; w/in 24 hrs, pt exp migraine & devel skin sensitivity;
cellulitis at the injection site; This spontaneous report was received from a pharmacist via a company representative referring to an elderly female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot number and expiration date were not reported) for prophylaxis, which was recommended by Centers for Disease Control and Prevention (CDC) for the patient's age.        On an unknown date the patient developed cellulitis at the injection site on the arm. It was unknown if patient sought any medical attention, received treatment or any lab/diagnostic tests were performed.  The outcome of the event was recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the event was not reported.
FEVER; Vomiting; fatigue; This is a spontaneous report from a contactable nurse.  A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient was still taking Xeljanz but doses missed due COVID vaccine. The patient also reported a general side effect of Xeljanz of fatigue. On an unspecified date patient experienced stomach bug which included fever, vomiting and fatigue. Outcome of the events fever, vomiting was resolved and for fatigue was not resolved.No follow-up attempts are possible; information about lot/batch cannot be obtained.
Report 20010038911 described vomiting, diarrhea, and general malaise in a 33 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis of hepatitis B. The vaccinee is allergic to oysters. Reportedly she had no medical history and took no concomitant medications. On 01/02/2001, the vaccinee received her second 20 mcg IM dose of Engerix-B. Within twelve hours post-vaccination, the vaccinee experienced vomiting, general malaise, and diarrhea. Symptoms resolved on 01/02/2001. As of 03/13/2001, the outcome of the events is resolved. The reporter has reported these adverse events directly to VAERS.
Headache & Myalgia Narrative: missed work following second dose of vaccine due to about symptoms
On 10/19/2000, the patient developed a temperature and tiny bumps. Unspecified medical attention was sought. Additional information has been requested.
Information has been received from a registered nurse concerning a 10 year old female patient with no allergies and family history of lupus who was vaccinated with two doses of GARDASIL.  The patient developed lupus after vaccination.  The vaccinations were administered at another location and no information was available on administration dates.  The onset of the systemic lupus was unclear.  The patient was performed unspecified blood and laboratory tests.  The patient was first seen at the office on 16-MAY-2008.  The patient's lupus persisted.  Upon internal review, lupus was determined to be an other important medical event.  Additional information has been requested.  7/14/2008 MR received from Rheumatology consult for initial and f/u visits 5/16/2008 and 5/29/2008. DX:  Raynauds. Probably Lupus with limited manifestations of disease at this time. Pt presented for eval of a 2 mon hx of cold induced vasospasm in the hands in conjunction with a high ANA. Pt had cold induced pallor to the level of the PIP joint. Occasional arthralgias w/o joint swelling.
Pfizer COVID vaccines received on 2/26/2021, 3/19/2021, and 9/29/2021 Hospitalized on 10/5/2021 with positive COVID 19, viral pneumonia, and chest pain
diagnosed with Cancer; This is a spontaneous report from a non-contactable pharmacist. A 72-year-old male patient received his first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 72-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of COVID-19 vaccine on 08Feb2021 and was reported to have been diagnosed with cancer on an unspecified date in 2021. The second dose was paused and the pharmacist was asking if it was still okay to get the second this late (into the 9th week). The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, the event is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.
NO ADVERSE EVENT NOTED OR REPORTED. Jynneos 0.1 ml, ID administered with no wheal production; therefore, additional dose administered with wheal production.
Patient started with muscular weakness below the knees with first vaccine and it got worse after second vaccine.
patient was given expired doses of pentacel with no adverse event; Initial information received on 05-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4-month-old male patient who was given expired doses of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) with no adverse event.  The patient's past medical history, medical treatment, vaccination, and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 04-Apr-2022, the patient received 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ414AAA and expiry date: 12-Mar-2022) via intramuscular route in the left thigh for Immunization.  On 04-Apr-2022 the patient developed a non-serious event, patient who was given expired doses of pentacel with no adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event patient who was given expired doses of pentacel with no adverse 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.
On same day (Saturday) as vaccine I got covid arm. Site around area was hard and as big around as an orange. Very itchy. Very sore. Rash from site down to wrist of left arm which is the arm I got shot in. Had all symptoms thru Tuesday. On the following Saturday one week later, all symptoms returned. Only this time the hard knot wasn?t as big. Maybe the size of a golf ball. Had symptoms till around tues or wed.  Site area continues to flare up, itchy rashy, fever like, maybe once a week. It?s Monday before I get my second dose Saturday coming up and it was hot and rashy for a few hours today.   Also, my whole life I?ve never had a period longer than 4 days and never have worn pads during my period only panty liners. Never had a heavy period. This month I started my period on 4/11/21 and for the first 5 or 6 days it was lite as usual but longer than normal. And a dark red. It?s now 4/19/21 and the last couple days it?s been very very heavy and bright red. With today 4/19 being the heaviest so far. There?s been no break in it. I?m now on day 8 and it?s heavier than it?s ever been my whole life. I?ve had a normal regular period since I was 15. I have no children by choice if that helps somehow.  I have not gone to the dr for any of these side effects.
This spontaneous report was received from a pharmacist regarding an approximately 55 year old female patient. There was no a pertinent medical history and drug reaction or allergies. On 15-OCT-2014, the patient was vaccinated with ZOSTAVAX, strength not reported, single dose, product lot# K007988, expiry date: 03-SEP-2015 subcutaneously in the left arm. The patient did not take any concomitant medication. On 16-OCT-2014, the next day after vaccination the patient developed a rash at the injection site. The patient self treated the rash with application of home laser named Q Laser. The area of the rash was now getting larger and was the size of a credit card. No laboratory diagnostics studies were performed. The patient sought medical attention by visiting pharmacy. No intervention was done to prevent the seriousness criteria. There was no product quality complaint involved. The outcome of the event was reported as not recovered. Additional information has been requested.
fever started in late afternoon on 23JAN96;had 3 szs 1st one 630PM 2-3mins;#2 7PM lasted 1-2mins;#3 8PM lasted 2-3mins;blanked out stared into space, arms swollen (not red) @ inj site & sore;fever 102-103 APAP given
Pt recvd 2nd dose of Hep B vax 24MAR87 & w/in 20 minutes of vax pt started wheezing; also exp nausea, itching, chest & throat tightness, difficulty breathing & nervousness; resp problems; vomiting, h/a, stiff neck, weakness, photophobia;
Diagnosed with Covid-19 on 07/28/2021. Patient reports having a dry cough, sore throat, conjunctivitis and stuffy nose since 7/24/2021. Pt received Monoclonal Antibodies on 7/29/2021. Reports being fully vaccinated with Covid-19 vaccine.
Cellulitis with brawny edema down left arm. Admitted to administer IV cefazolin, converted to oral cephalexin. Returned to duty.
Patient had complete series of pfizer covid vaccine in january/february 2021.  admitted to medical center on july 29th with covid.  patient tested positive for covid on 7/27 per patients report.  Unknown vaccination site.  Covid 19 confirmed again by pcr at our hospital during admit on 7/29.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Patient called pharmacy c/o nausea, vomiting, diarrhea. Told patient -if symptoms continue or worsen seek medical attention at nearest emergency room.
WAS ACCIDENTALLY GIVEN A BOOSTER DOES OF 0.25ML INSTEAD OF A FULL SECOND DOSE OF 0.5ML.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information on patient's medical history or concurrent conditions was provided. ON approximately 15-OCT-2015 (reported as about 4 days ago), the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). No information on patient's concomitant medication was provided. In October 2015, the patient developed rash around injection site, about 6 inches in diameter  with red center, post ZOSTAVAX. Rash was reported just around injection site. No treatment was given to the adverse event. The outcome of rash around injection site was reported as not recovered. The causality between rash around injection site and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
father states pt has Reynauds synd which began last fall & has gotten progressively worse;pt has been under a lot of stress makes straight A's & has lost weight;hands have been cold;hands get so blue & cold it is scary;taken to hosp;
This is a spontaneous report by a contactable consumer and then from a contactable physician. This male consumer reported on behalf of his two month old daughter who received PREVNAR 13 single dose on thigh of the right leg on 12Sep2012 at 11:35. Relevant medical history was unknown. Vaccine given on the same day included ROTARIX oral vaccine and Hepatitis B vaccine given on left thigh. Vaccines taken within the last four weeks were none. On 12Sep2012 at 11:35 while administration the needle of the vaccine broke due to which only some of the vaccine was injected and the broken needle remained in her right thigh and her right leg was bleeding. The patient did not have any sibling. Relevant lab data was none. The physician clarified that this was not a malfunction of the vaccine. The needle separated from the pre-loaded syringe when the nurse was giving me vaccine. However we put the needle in the syringe so it was not a manufacturer error. At the time of the report the outcome was unknown. Follow-up (15Oct2012): New information received from a contactable physician includes: confirmation of the events and reaction details. Follow-up attempts completed. No further information expected. Follow-up (08NOV2012) Follow-up attempts completed. No further information expected.
FATIGUE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and back pain, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 09:30 for prophylactic vaccination. Concomitant medications included atorvastatin for diabetes, metformin for diabetes, and saxagliptin for diabetes. On 04-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
One min. after vaccines, went pale and rigid in all limbs with slight jerking for 15 seconds. Loss of consciousness for 1 1/2 min. Alert to name and place at but tired and groggy at 2 min. At 5 minutes was able to stand and walk.
Three weeks after my 2nd  covid 19 dose, I experienced severe joint pains in arms, hands, back, and hip to the point of not being able to take care of my daily routine, ie shower, cooking ect. I was in tears as it was really debilitating . I made appointment with my pcp at that time, Nurse practicioner. He referred me to a pain clinic. They proscribed anti inflammatories that did not help. I went to Physical therapy which helped more. I do the exercizes daily now, but I'm still debilitated in moving the way I used to. It was a sudden overnight onset which was very alarming. I reported to Dr that I'd gotten the Pfizer vaccine three weeks prior to this onset.
Patient received both vaccines on 11/29/22. She reported feeling dizzy and feeling a funny sensation in chest within one minute of administration. Vital signs were checked and HR 96 RR 20 BP 162/90, Sp02 99%. Blood sugar was 147. Heart and lungs sounds were normal. After a few minutes patient felt chest symptoms were gone. Reported dizziness persisted, repeat BP were all about the same at 20-30 minutes after. Patient stated did not take her HTN medication that morning.
Patient reports itchy rash with eruptions on trunk and arms. Has been taking benadryl which helps but when that wears off it flares up again. She also applys OTC hydrocortisone.
I just opened up at the pharmacy.  There were patients waiting to pick up meds, and 1 patient asked for shingles and flu shots, then came 2 patients asking for 1st covid shot, since one is under age, I gave pfizer shot, the other person also wanted Pfizer.  Then again came another person who had appointment for 2nd covid shot.  I tried to pass out consent forms, printed up vis for shingles and flu, (I am a floater pharmacist), mixed the shots.  administered.  and even tried to help patients picking up meds in between.  Somehow, I neglected to ask the other person receiving the covid shot which one it was, on the form it was blank.  His 1st shot was Moderna
I was 21 weeks pregnant at the time. I experienced a brief episode of vertigo on 1/28/2021, and had a return of the vertigo on 2/4/2021 that lasted all day.  I called my OBGYN thinking it could be pregnancy-related, and was referred to OB triage for monitoring and treatment with IV fluids and Zofran. I made another trip to OB triage on 4/8/2021 for the same reason. The symptoms would fluctuate in severity but never let up, and I?m still dealing with episodes of dizziness to this day. I?ve seen specialists including a neurologist, ENT specialist, audiologist, and am currently in weekly vestibular therapy for my symptoms. Ultimately, I?ve been given a differential diagnosis of vestibular neuritis vs vestibular migraine. I may have been experiencing BPPV when the symptoms began, as well. A neurologist I work closely with believes the symptoms I?ve experienced could be relayed to the COVID-19 vaccine (2nd dose was received on 1/22/2021).
Mother called 5 days after shot. Said there was a lump where shot was adm. Arm was swollen, warm and painful. No fever noted. Child did not miss school. Adm ice packs - swelling remained x 1 week. Skin discoloration - penny sized - reported.
Pt has history of Hepatitis B. 17Dec97 Pt recv vax SC. No concomitant med. Approx 12 days later, pt devel generalized varicella-form rash of 60-80 lesions.Pt stated had fever 2 days prior to eruption.
Extreme Heart palpitations, extreme heat in my body and ches,  pressure on the chest, lightheaded, diarrhea, insomnia, fatigue, bad taste in the mouth, sores in the mouth (lips), body shivering,  soreness in the arm of the injection site.  Lasted for a week.  But mainly it was worst the first two days, right the day on the injection, and the day after symptoms were extremely bad..
Vaccine given outside of the beyond use date of 7/19/2021. Vaccine was given 7/20/2021. No adverse symptoms
Information has been received from a female who was vaccinated with MMR II, in the 1970's. Subsequently the pt developed severe ulcerations in the mouth and she was subsequently diagnosed with ulcerative colitis. Unspecified medical attention was sought. Upon internal review, ulcerative colitis was considered an other important medical event (OMIC). The pt reported that her older sister experienced the same reactions when she was vaccinated with MMR II (WAES0211USA00719). Additional info has been requested.
Placed in the fridge and given beyond the 30-day expiration to 7 patients; No adverse event; Dose given beyond 30-day expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event) in a 21-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients).    The caller called and said that the vials were initially stored in the refrigerator on 06-Jul-2022. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown. The caller needed information on stability after 30 days and if there are recommendations on revaccination.  The vials did not undergo any temperature excursions.  No concomitant medication reported. No treatment medication reported.