chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extra dose of ACTHIB was inadvertently administered to a patient with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient  to whom extra dose of HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Nov-2022 extra dose 0.25 ml (once) dose of suspect HIB (PRP/T) VACCINE (formulation: unknown) (lot UJ636AA , strength, standard) via unknown route in the thigh NOS (not otherwise specified) for immunization was inadvertently administered to a patient with no reported adverse event (extra dose administered) (latency: same day).  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.
After vaccination pt got a very high fever and became very ill. His attitude and behavior was indifferent after the vaccination.
SUSPECTED COVID-19 INFECTION; REALLY SORE MOUTH; NOT FEELING RIGHT; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: not reported) dose was not reported, 1 total, administered on 09-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-AUG-2021, the patient was tested positive for coronavirus disease (Covid-19) (suspected clinical vaccination failure). Patient's only symptoms were sore mouth and he was not feeling right. Patient's primary care physician (PCP) was aware of the complaint. On an unknown date, patient experienced suspected covid-19 infection. Patient's wife (who had received the first dose of Moderna) and children (unvaccinated) were tested negative for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection, really sore mouth and not feeling right was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210837418-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
20 minutes after shot, I went from feeling fairly normal to very suddenly had very severe problems including dizziness, confusion , significant difficulty breathing, significant difficulty staying conscious, tingling all over, loss of control of some body movements,  inability to sit or stand, pulse dropped to 51 according to medic,.  I believed I was dying.  Medic indicated I turned "white".  The symptoms peaked within 1-2 minutes after onset and stayed bad for several minutes.  After a few  minutes  My pulse started to increase and  all symptoms started improving.  Within 10 minutes I was feeling well enough to sit, and within 30 minutes I was able to drive home.
Pt recv vax on 1/11/99; on same day pt exp swelling/ redness of leg w/ soreness, vomiting, fever (105), unable to eat
Pt received 3rd anthrax dose on 20 Feb 03 in right upper arm.  Now c/o of eczema-like dermatitis of back of her neck , headache and malaise for 6 days.  Pt afebrile, no finding at the injection site.  Vital signs are stable.  Symptomatic treatment provided with topical steroids for the skin rash and NSAIDS for headache.  Close f/u recommended in the 24-48-72 hours.
PATIENT GOT THE SHOT & COMPLAINED OF FEELING DIZZY.  HER MOM WAS WITH HER. SHE WAS PROVIDED WITH WATER & FELT OK. SHE SAID SHE GAVE HER EXAM AND CAME TO GET SHOT, DID NOT EAT OR DRINK. THEN SHE FAINTED FOR SECONDS.  WE CALLED 911 & AMBULANCE.  SHE WAS CONSCIOUS AGAIN, SAID SHE IS FEELING BETTER. THEN AFTER 2 MIN FAINTED AGAIN. WAS BREATHING OK.  AMBULANCE ARRIVED AND SHE WAS CONSCIOUS AGAIN. SHE FELT BETTER AS SHE DRANK WATER.  SHE WAS OFFERED TO GO TO HOSPITAL IN AMBULANCE BUT PREFERRED TO GO TO HOSPITAL WITH HER MOM IN CAR.  SHE SAID SHE WAS FEELING MUCH BETTER WHEN SHE LEFT.  RECOMMENDED TO KEEP HER HYDRATED AND GIVE ELECTROLYTES AND WATER
Mixed series ? Incorrect mRNA COVID-19 vaccine product administered for second dose in 2-dose series First dose: Pfizer/ Second Dose: Moderna
2-3 hrs p/vax pt said head hurt & was trembling all over, felt hot;
Patient given vaccine from punctured vial that was on the counter since 16Jul2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication were reported. No information on treatment medication were reported.
I appear to be developing Shingles.; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on 16Apr202 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. As of 20Apr2021, the patient appeared to be developing shingles (event start date: 20Apr2021). The outcome of the event was unknown. The outcome of the event was non-serious.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Patient and Guardian both verified birth date of 06/28/2009 but insurance has DOB as 06/28/2010 making patient underage for current guidelines
Patient felt tingly arm in injection arm 20 minutes after injection. Patient was given 25mg Benadryl and reported feeling much better and left on own accord.
patient received both immunizations 10/7 on 10/9 she started with a spot or 2 on her back that would hurt when itched. by 10/11-10/12 it has spread around under her breast line to stomach area with same pain when itched. she called to inform us about this reaction and said it seemed to be getting better today. she would call if it got worse or if she has to seek treatment.
rheumatoid arthritis flare up; experienced inability to get out of bed; sickness; FACILITATED COLLECT This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in 2021 at dose 1, single and the second dose intramuscularly in 2021 at dose 2, single for COVID-19 immunisation; patient started to receive adalimumab (HUMIRA solution for injection in pre-filled pen, citrate free) subcutaneously for moderate to rheumatoid arthritis; prednisone for unspecified indication. Medical history included moderate to rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications were not reported. In 2021, the patient experienced inability to get out of bed, sickness and rheumatoid arthritis flare up. The patient also experienced prednisone with no effect. The events were reported as follows: patient experienced events of non-serious inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up with adalimumab. In 2021, the patient experienced inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up. Prednisone and BNT162b2 were also considered suspect. The action taken with adalimumab and prednisone was unknown. The patient was recovering from the events.    Causality for adalimumab: the reporter's causality for the event(s) of inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up was not provided.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Rheumatoid arthritis, Mobility decreased, and Illness and the suspect drugs.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Patient with significant erythematous reaction to left deltoid ~ 13x20 cm in size.  Progressively increasing in size. Tx for concern of cellulitis vs. localized reaction due to Prevnar 13.
Received the Bivalent Pfizer on 10/6/22 and again on 10/10/22 by another healthcare facility . No reaction.
I have experienced weakness, headache, stomach pains, lethargic, muscle aches (legs feeling 'heavy') for the past 18 days.  Last night I took my temperature because I was feeling worse and found out I had a low grade fever (99.6).  Today is Sunday and I cannot call my doctor until tomorrow, but I will report this to him then. I have no idea whether I was exposed to the virus before immunity kicked in, or if this is a 'breakthrough' virus or if it is something else.  That is why I will call my Dr. in the morning. I did however want to report the adverse side affects to you so you would be aware of what transpired with me after my second dose of Moderna. Obviously, none of my side affects have been serious, but they have been bothersome and left me worried because I have been feeling ill for almost 3 weeks.
Dizziness, felt faint, diaphoretic, immediately after injection.  Reclined and recovered after 5 minutes.
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from a contactable nurse. An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) Intramuscularly on 13Jan2021 at single dose for COVID-19 immunization in a nursing home/senior living facility. Medical history included s/p cerebrovascular accident (CVA), Insulin dependent diabetes mellitus (IDDM) and hypertension (HTN). The patient had no allergies with medications, food or other products. Concomitant medication included insulin glargine (LANTUS). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The resident (patient) tested positive in the SARS-Cov2-RT PCR (nasal swab) on 01Feb2021. Patient did not receive treatment for the adverse event. Event was considered by the reporter as non-serious. Outcome of events was recovering.  Information on the lot number and batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.
Extreme fatigue, weakness, muscle aches, steady headache, from 2 pm until next day. Still fatigued and some dizziness and weakness on second day. Headache diminished. Slight queasy feeling. On third day, one incident of weakness almost to point of fainting. Improved after lying down for 15 minutes. Sore arm.  Almost 10 days after injection, raised welt and itching area at injection site. Still itchy  14 days after shot. No other symptoms.
Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2016552260) on 09-FEB-2017. This case involves a female patient (onset age was unknown) who was vaccinated with dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to tetanus-itching. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Daily and nightly headache for 2 mo.  Severe debilitating insomnia for 2 1/2 weeks.  Intermittent burning sensation in my chest for approximately 6-7 weeks , improving.
Unbelievably severe back pain; This is a spontaneous report from a contactable Physician.  A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknow date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient complained of unbelievably severe back pain that lasted a few days. The patient recovered on unknown date. Information on the lot/batch number has been requested.
Vaccine given to a 16 year old female patient. Patient was not at the age to receive vaccine.
Patient received 3 doses of SHINGRIX but only 2 are required. Patient did not report any syptoms.
Blister on both sides of the tongue occurred, patient given dexamethasone to sinse
While in observation area for 30 min pt reported dizziness. Continued to monitor pt still reports dizziness. Pt moved to area with monitor for closer observation. Pt states she felt better but still reported dizziness with sitting and standing. EMS called to transport pt to ER. Initial BP 196/83 HR 90 RR 22 99% RA. Pt assisted to lie on stretcher. Continued to monitor pt. Pt reports her dizziness improved with lying down. Reinforced to pt to go to ER for further evaluation and monitoring and not driving with dizziness for her safety. Pt agrees to go to ER for further evaluation. Pt states she will go to ER but she is not staying because she needs to go home. EMS here to transport Pt to ER. Dstick done by EMS 106 mg ldL. Sinus rhythm on monitor no sigs or symptoms of respiratory distress noted at this time or at time of transport from clinic area. Pt alert oriented x 4 upon while in clinic and at time of transport to ER. Report called to Nurse in ER.
headache; Fatigue; injection site pain; Dose Number: 3; 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), administered in arm left, administration date 24Nov2021 10:30 (Lot number: 33026bd) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "latex" (unspecified if ongoing); "pcn" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; OMEPRAZOLE; MELATONIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Neomyocin, reaction(s): "known allergies: neomyocin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ep6955, Location of injection: Arm Left), administration date: 02Apr2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 10:30, outcome "unknown", described as "Dose Number: 3"; HEADACHE (non-serious) with onset 25Nov2021 17:00, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 25Nov2021 17:00, outcome "recovered" (2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 25Nov2021 17:00, outcome "recovered" (2021), described as "injection site pain". Therapeutic measures were taken as a result of headache, fatigue, vaccination site pain. No follow-up attempts are possible. No further information is expected.
Fever, discomfort. Joint pain everywhere. Back pain. Muscle spasms. Uncomfortable but not unbearable.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VAQTA lot # N008823 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA.; Sender's Comments:  US-009507513-1709USA003454: US-009507513- 1709USA003453: US-009507513-1709USA003455:
Administration 9/19/12. All is OK, pt comes in on 9/21/12 reporting a swollen arm hot and tender to touch. We were attempting to present her to clinic but she went to ER.
This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 02-MAR-2018, the patient was vaccinated with an improperly stored Oka-Merck PROQUAD for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). The temperature excursion was reported from 6°F to 14°F, and the time frame was reported as 1 hour and 30 minutes. Previous temperature excursion was reported from -9°C to 9°C (-6.4°C) for a time frame of 3 hours. Data logger was reported. Merck sterile diluent was used to reconstitute the vaccine. No product quality complain was present. This is one of several reports received from the same reporter.
Patient became light headed and diaphoretic, and vasovagal Vitalsigns monitored, given orange juice. Patient stable within 15-20 minutes
not doing fine; achy; low grade fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not doing fine), PAIN (achy), PYREXIA (low grade fever) and FATIGUE (fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (not doing fine), PAIN (achy), PYREXIA (low grade fever) and FATIGUE (fatigue). At the time of the report, MALAISE (not doing fine), PAIN (achy), PYREXIA (low grade fever) and FATIGUE (fatigue) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Information has been received from a registered nurse concerning a 26 year old white female on contraceptive therapy who, due to negative rubeola titers, on 6/12/02, at 13:55, was vaccinated IM in the left upper arm with a booster dose of MMR II (637255/1380K). On 6/16/02 the pt started to feel "run down." In follow-up, the nurse reported that on 6/16/02 the pt developed a headaches, fatigue, and a fever of 101 degrees. On 6/17/02 the pt's fever increased to 103 degrees, her fatigue and headache worsened, and she developed swollen glands in the axilla bilaterally. The pt was treated with ibuprofen for the fever. On 6/20/02, the pt recovered from the fever, headache, fatigue and swollen glands, with the following lab values: white blood count 3.5, erythrocyte sedimentation rate normal, and Epstein-Barr antibodies screen was normal. On 6/20/02, the pt had returned to work, and the nurse reported that the pt "felt better," was afebrile, "exam" was negative, and the pt denied rash, sinus tachycardia, nausea, vomiting, arthralgia, or cough. It was reported that the pt worked with lab monkeys that needed to be protected. It was also reported that the pt's sister had an adverse reaction after the second dose of rabies vaccine at 25 years of age. No further info is expected.
Flare up of plaque psoriasis; First injection reaction was fever and sore; First injection reaction was fever and sore; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flare up of plaque psoriasis), PYREXIA (First injection reaction was fever and sore) and VACCINATION SITE PAIN (First injection reaction was fever and sore) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (First injection reaction was fever and sore) and VACCINATION SITE PAIN (First injection reaction was fever and sore). On an unknown date, the patient experienced PSORIASIS (Flare up of plaque psoriasis). At the time of the report, PSORIASIS (Flare up of plaque psoriasis) had not resolved and PYREXIA (First injection reaction was fever and sore) and VACCINATION SITE PAIN (First injection reaction was fever and sore) outcome was unknown.            No concomitant medications were reported. On an unknown date, the patient experienced flare up of Plaque psoriasis. In 2021, the patient experienced Moderna vaccination reaction/first injection reaction was fever and sore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623160 (Patient Link).